Scientific publications

Arlett P.Building an Evidence Base on the Place of Industry-Sponsored Programs in Drug Safety Surveillance, Drug Saf. 2019 May;42(5):581-582. doi: 10.1007/s40264-018-00791-1.

Brown PBahri PEngagement’ of patients and healthcare professionals in regulatory pharmacovigilance: establishing a conceptual and methodological frameworkEur J Clin Pharmacol (2019).

Cave A., Kurz X., Arlett PReal world data for regulatory decision making: challenges and possible solutions for EuropeClin Pharmacol Ther. 2019 Apr 10. doi: 10.1002/cpt.1426. [Epub ahead of print]

Cerreta F, EMA geriatric expert drafting group.New harmonized considerations on the evaluation instruments for baseline characterisation of frailty in the European Union., Br J Clin Pharmacol. 2019 Jul 5. doi: 10.1111/bcp.14044. [Epub ahead of print]

Coppola PAndersson ACole S., The Importance of the Human Mass Balance Study in Regulatory Submissions., CPT Pharmacometrics Syst Pharmacol. 2019 Sep 12. doi: 10.1002/psp4.12466. [Epub ahead of print]

De Wit MCooper CTugwell PBere NKirwan JConaghan PGRoberts CAujoulat IAl-Daghri NAraujo de Carvalho IBarker MBedlington NBrandi MLBruyere OBurlet NHalbout PHiligsmann MJiwa FKanis JALaslop ALawrence WPinto DPrieto Yerro CRabenda VRizzoli RScholte-Voshaar MVlaskoyska M. Reginster JYPractical guidance for engaging patients in health researchtreatment guidelines and regulatory processes: Results of an expert group meeting organized by the World Health Organization (WHO) and the European Society for Clinical and Economic Aspects of OsteoporosisOsteoarthritis and Musculoskeletal Diseases (ESCEO)Aging Clin Exp Res (2019)

Eichler H-GEnzmann HRasi GAdded therapeutic benefit and drug licensingNRDD April 2019doi: 10.1038/d41573-019-00068-x

Eichler H GKoenig F,  Arlett P,  Enzmann H,  Humphreys APétavy FSchwarzer‐Daum BSepodes BVamvakas SRasi G Are novelnon‐randomised analytic methods fit for decision‐making? The need for prospectivecontrolled and transparent validation Clin Pharm Ther2019, doi:10.1002/cpt.1638

Gini RFournie XDolk HKurz XVerpillat PSimondon FStrassmann VApostolidis KGoedecke T., The ENCePP Code of Conduct: A best practise for scientific independence and transparency in noninterventional postauthorisation studies, Pharmacoepidemiol Drug Saf. 2019 Apr;28(4):422-433. doi: 10.1002/pds.4763.

Haberkamp MMoseley JAthanasiou Dde Andres-Trelles FElferink ARosa MMMagrelli A., European regulators’ views on a wearable-derived performance measurement of Ambulation for DMD regulatory trials, Neuromuscul Disord. 2019 Jul;29(7):514-516. doi: 10.1016/j.nmd.2019.06.003.

Hedenmalm KBlake KDonegan KMacia MAGil MWilliams JMontero DCandore GMorales DKurz XArlett P., A European multi-centre drug utilisation study of the impact of regulatory measures on prescribing of codeine for pain in children, Pharmacoepidemiol Drug Saf. 2019;1-11

Hedenmalm KSlattery JSkibicka-Stepien IKurz XMorales DPrescribing patterns of tramadol in adults in IMS® primary care databases in France and Germany between 1 January  2006 and 30 June 2016Eur J Clin Pharmacol. 2019 Jan 23. doi: 10.1007/s00228-018-02622-9. 

Hedenmalm K, Kurz X, Morales DEffect of withdrawal of fusafungine from the market on prescribing of antibiotics and other alternative treatments in Germany: a pharmacovigilance impact studyEur J Clin Pharmacol. 2019 Mar 5. doi: 10.1007/s00228-019-02650-z. [Epub ahead of print]

Herold RCamarero JMelchiorri DSebris ZEnzmann HPignatti F., Revocation of the conditional marketing authorisation of a cancer medicine: The olaratumab experience, Eur J Cancer. 2019 Oct 23;123:25-27. doi: 10.1016/j.ejca.2019.09.020. [Epub ahead of print]

Hidalgo-Simon A., From laboratory to patient - the evolving path to become a medicineMOLECULAR FRONTIERS JOURNALVolume 3Number 2December 2019

Hines PAGuy RHHumphreys AJPapaluca-Amati M., The European Medicines Agency’s goals for regulatory science to 2025Nat Rev Drug Discov. 2019 Jun;18(6):403-404. doi: 10.1038/d41573-019-00071-2.

Hines PHiu Yu LGuy RHBrand APapaluca-Amati M.Scanning the horizon: a systematic literature review of methodologiesBMJ Open. 2019 May 27;9(5):e026764. doi: 10.1136/bmjopen-2018-026764.

Jauregui BHudson LDBecnel LBNavarro Almario EFitzmartin RPétavy FSeigneuret NMalone JKZhou FLGalvez JJackson THarmon NKush RDThe Turning Point for Clinical Research: Global Data StandardizationApplied Clinical Trials Online22 January 2019.

Kashoki MHanaizi ZYordanova SVeselý RBouygues CLlinares JKweder SL., A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: ConcordanceDiscordanceand Why, Clin Pharmacol Ther. 2019 Jul 15. doi: 10.1002/cpt.1565. [Epub ahead of print]

Kehoe TBlind EJanssen H. Regulatory Aspects of the Development of Drugs for Metabolic Bone Diseases, Br J Clin Pharmacol. 2019 Jun;85(6):1208-1212. doi: 10.1111/bcp.13791. Epub 2018 Dec 3.

Lenić IBlake KGarcia-Arieta APotthast HWelink J., Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications,Clin Transl Sci. 2019 Sep;12(5):490-496. doi: 10.1111/cts.12642.

Lienhardt CVernon AACavaleri MNambiar SNahid P., Development of new TB regimens: Harmonizing trial designproduct registration requirementsand public health guidance.PLoS Med. 2019 Sep 6;16(9):e1002915. doi: 0.1371/journal.pmed.1002915. eCollection 2019 Sep.

Mavris MFuria Helms ABere N, Engaging patients in medicines regulation: a tale of two agencies.Nature Reviews Drug DiscoveryISSN 1474-1784 (online)

McGettigan PAlonso Olmo CPlueschke KCastillon MNogueras Zondag DBahriKurz XMol PGM, Patient Registries: An Underused Resource for Medicines EvaluationDrug Saf. 2019 Jul 13. doi: 10.1007/s40264-019-00848-9. [Epub ahead of print]

Morales DPacurariu ASlattery JPinheiro LMcGettigan PKurz X., Association Between Peripheral Neuropathy and Exposure to Oral Fluoroquinolone or Amoxicillin-Clavulanate TherapyJAMA Neurol. 2019 Apr 29. doi: 10.1001/jamaneurol.2019.0887. [Epub ahead of print]

Morales DRSlattery JPacurariu APinheiro LMcGettigan PKurz XCorrection to: Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case-Control StudyClin Drug Investig. 2019 Feb;39(2):215. doi: 10.1007/s40261-019-00755-y.

Morgan EMMunro JEHoronjeff JHorgan BShea BFeldman BMClairman HBingham CO 3rdThornhill SStrand VAlongi AMagni-Manzoni Svan Rossum MAJVesely RVojinovic JBrunner HIHarris JGHorton DBLovell DJMannion MRahimi HRavelli ARingold SRuperto NSchrandt MSShenoi SShiff NJToupin-April KTzaribachev NWeiss PConsolaro A., Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop., J Rheumatol. 2019 Aug;46(8):1006-1013. doi: 10.3899/jrheum.181088. Epub 2019 Feb 15.

Nielsen SMTugwell Pde Wit MPTBoers MBeaton DEWoodworth TGEscorpizo RShea BToupin-April KGuillemin FStrand VSingh JAKloppenburg MFurst DEWells GASmolen JSVeselý RBoonen AStorgaard HVoshaar MMarch LChristensen R; Contextual Factors Working Group, Identifying Provisional Generic Contextual Factor Domains for Clinical Trials in Rheumatology: Results from an OMERACT Initiative, J Rheumatol. 2019 Sep;46(9):1159-1163. doi: 10.3899/jrheum.181081. Epub 2019 Jan 15.

Nordenmalm SKimland ELigas FLehmann BClaverol JNafria BTötterman AMPelle B.,Children’s views on taking medicines and participating in clinical trials, Arch Dis Child. 2019 Sep;104(9):900-905. doi: 10.1136/archdischild-2018-31651

Ollivier CSun HAmchin WBeghetti MBerger RMFBreitenstein SGarnett CGullberg NHassel PIvy DKawut SMKlein ALesage CMigdal MNije BOdermarsky MStrait Jde Graeff PAStockbridge N. New strategies for the conduct of clinical trials in pediatric Pulmonary Arterial Hypertension (PAH): Outcome of a multi-stakeholder meeting with patientsacademiaindustry and regulators held at the European Medicines Agency on Monday 12th June 2017J Am Heart Assoc. 2019 May 21;8(10):e011306.

Ollivier CThomson AManolis EBlake KKarlsson KEKnibbe CAJPons GHemmings RCommentary on the EMA Reflection Paper on the use of extrapolation in the development of medicines for paediatricsBr J Clin Pharmacol. 2019 Feb 1. doi: 10.1111/bcp.13883. [Epub ahead of print]

Olmo CA, McGettigan P, Kurz XBarriers and opportunities for use of patient registries in medicines regulationClin Pharmacol Ther. 2019 Apr 10. doi: 10.1002/cpt.1414. [Epub ahead of print]

Pearson ADJScobie NNorga KLigas FChiodin DBurke AMinard-Colin VAdamson PMarshall LVBalakumaran A0Benettaib BBhargava PBollard CMBolotin EBomken SBuechner JBurkhardt BCaron HCopland CDemolis PEgorov AFarhan MZugmaier GGross THorton-Taylor DKlapper WLesa GMarcus RMiles RRNottage KPacaud LRicafort RSchrappe MSterba JVezan RWeiner SKim SYReaman GVassal GACCELERATE and European Medicine Agency Paediatric Strategy Forum for medicinal product development for mature B-cell malignancies in childrenEur J Cancer. 2019 Feb 14;110:74-85. doi: 10.1016/j.ejca.2019.01.013. [Epub ahead of print]

Pelfrene EHarvey Allchurch MNtamabyaliro NNambasa VVentura FVNagercoil Net al. The European Medicines Agency’s scientific opinion on oral fexinidazole for human African trypanosomiasis. PLoS Negl Trop Dis 13(6): e0007381.

Pelfrene ESebris ZCavaleri M, Comment on FauconnierA. Phage Therapy Regulation: From Night to Dawn, Viruses 201911771; doi:10.3390/v11090771

Potts JGenov GSegec ARaine JStraus SArlett P, Improving the Safety of Medicines in the European Union: From Signals to Action Clin Pharmacology Ther.Dec 2019doi: 10.1002/cpt.1678

Schneeweiss SRassen JABrown JSRothman KJHappe LArlett PDal Pan GGoettsch WMurk WWang SV.Graphical Depiction of Longitudinal Study Designs in Health Care DatabasesAnn Intern Med. 2019 Mar 19;170(6):398-406. doi: 10.7326/M18-3079.

Schuessler‐Lenz MEnzmann HVamvakas S, Regulators' Advice Can Make a Difference: European Medicines Agency Approval of Zynteglo for Beta Thalassemia, Clin Pharmacol Ther.Nov 2019doi: 10.1002/cpt.1639

Selker HPEichler HGStockbridge NLMcElwee NEDere WHCohen TErban JKSeyfert-Margolis VLHonig PKKaitin KIOye KAD'Agostino RB SrEfficacy and Effectiveness Too (EE2) Trials:Clinical Trial Designs to Generate Evidence on Efficacy and on Effectiveness in Wide PracticeClin Pharmacol Ther. 2019 Jan 4. doi: 10.1002/cpt.1347. [Epub ahead of print]

Sheean MEMalikova EDuarte DCapovilla GFregonese LHofer MPMagrelli AMariz SMendez-Hermida FNistico RLeest TSipsas NVTsigkos SVitezic DLarsson KSepodes BStoyanova-Beninska V., Nonclinical data supporting orphan medicinal product designations in the area of rare infectious diseases., Drug Discov Today. 2019 Nov 5. pii: S1359-6446(19)30419-2. doi: 10.1016/j.drudis.2019.10.015. [Epub ahead of print]

Stephenson DHill DCedarbaum JMTome MVamvakas SRomero KConrado DJDexter DTSeibyl JJennings DNicholas TMatthews DXie ZImam SMaguire PRussell DGordon MFStebbins GTSomer EGallagher JRoach ABasseches PGrosset DMarek K; Critical Path for Parkinson’s Consortium, The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson's Disease, J Parkinsons Dis. 2019;9(3):553-563. doi: 10.3233/JPD-191648.

Sturkenboom MBahri PChiucchiuini AGrove Krause THahné SKhromava AKokki MKramarz PKurz XLarson HJde Lusignan SMahy PTorcel-Pagnon LTitievsky LBauchau V; ADVANCE consortium, Why we need more collaboration in Europe to enhance post-marketing surveillance of vaccines, Vaccine. 2019 Oct 31. pii: S0264-410X(19)31002-3. doi: 10.1016/j.vaccine.2019.07.081. [Epub ahead of print]

Sultana JZaccaria Cde Lisa RRossi FCapuano AFerrajolo C., Good Pharmacovigilance Practice in Paediatrics: An Overview of the Updated European Medicines Agency Guidelines, Paediatr Drugs. 2019 Oct;21(5):317-321. doi: 10.1007/s40272-019-00350-w.

Tanniou J, Smid SC, van der Tweel I, Teerenstra S, Roes KCBLevel of evidence for promising subgroup findings: the case of trends and multiple subgroupsStat Med. 2019 Mar 13. doi: 10.1002/sim.8133. [Epub ahead of print]

Tervonen TAngelis AHockley KPignatti FPhillips LD.Quantifying Preferences in Drug Benefit-Risk Decisions, Clin Pharmacol Ther. 2019 Nov;106(5):955-959. doi: 10.1002/cpt.1447. Epub 2019 Apr 24. PMID: 30929257

Torcel-Pagnon LBauchau VMahy PTin Tin Htar Mvan der Sande MMahé CKrause TGCharrat ASimondon FKurz X; ADVANCE Consortium. Guidance for the governance of public-private collaborations in vaccine post-marketing settings in Europe. Vaccine. 2019 May 6. pii: S0264-410X(19)30561-4. doi: 10.1016/j.vaccine.2019.04.073. [Epub ahead of print]

Tzogani KFlorez BMarkey GCaleno MOlimpieri OMMelchiorri DHovgaard DJSarac SBPenttilä KLapveteläinen TSalmonson TBergh JGisselbrecht CPignatti F., European Medicines Agency review of ixazomib (Ninlaro) for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, ESMO Open. 2019 Sep 8;4(5):e000570. doi: 10.1136/esmoopen-2019-000570. eCollection 2019.

Vannice KS, Cassetti MC, Eisinger RW, Hombach J, Knezevic I, Marston HD, Wilder-Smith A, Cavaleri M, Krause PRDemonstrating vaccine effectiveness during a waning epidemic: a WHO/NIH meeting report on approaches to development and licensure of Zika vaccine candidatesVaccine. 2019 Jan 10. pii: S0264-410X(18)31713-4. doi: 10.1016/j.vaccine.2018.12.040. [Epub ahead of print]

van Stekelenborg JEllenius JMaskell SBergvall TCaster ODasgupta NDietrich JGama SLewis DNewbould VBrosch SPierce CEPowell GPtaszyńska-Neophytou AWiśniewski AFZTregunno PNorén GNPirmohamed M., Recommendations for the Use of Social Media in Pharmacovigilance: Lessons from IMI WEB-RADRDrug Saf. 2019 Dec;42(12):1393-1407. doi: 10.1007/s40264-019-00858-7.

Whomsley RBrendler-Schwaab SGriffin EJensen JMoermond CScholz BSortvik Nilssen LStemplewski HRoennefahrt I., Commentary on the draft revised guideline on the environmental risk assessment of medicinal products for human useEnvironmental Sciences Europe volume 31Article number: 17 (2019)

Wolff-Holz ETiitso KVleminckx CWeise M., Evolution of the EU Biosimilar Framework: Past and Future, BioDrugs. 2019 Dec;33(6):621-634. doi: 10.1007/s40259-019-00377-y.

Aartsma-Rus AMercuri EVroom EBalabanov PMeeting report of the "Regulatory Exchange Matters" session at the 5th International TREAT-NMD Conference: Lessons in communication: How an early dialogue between patientsregulators and academics can further therapy development for neuromuscular disorders FreiburgGermany27-29 November 2017Neuromuscul Disord. 2018 Jul;28(7):619-623. doi: 10.1016/j.nmd.2018.04.009. Epub 2018 Apr 20

Alteri E, Guizzaro L.Be open about drug failures to speed up research, Nature. 2018 Nov;563(7731):317-319

Amaouche N.Casaert Salome H.Collignon O.Roldao Santos M.Ziogas C., Marketing authorisation applications submitted to the European Medicines Agency by small and medium-sized enterprises: an analysis of major objections and their impact on outcomes, Drug Discovery TodayVol 23 (10)pp. 1801-1805October 2018

Arlett PRapid response to: Pandemrix vaccine: why was the public not told of early warning signs?BMJ 2018;362:k3948

Bahri PRägo L; CIOMS Working Group on Vaccine SafetyCIOMS Guide To Vaccine Safety Communication - Executive summaryVaccine. 2019 Jan 14;37(3):401-408. doi: 10.1016/j.vaccine.2018.11.082. Epub 2018 Dec 13.

Bahri P.Castillon Melero M.Listen to the public and fulfil their information interests - translating vaccine communication research findings into guidance for regulatorsBr J Clin Pharmacol. 2018 Mar 24. doi: 10.1111/bcp.13587. [Epub ahead of print]

Barkholt L.Voltz-Girolt C.Raine J.Salmonson T.Schüssler-Lenz M.Regulatory watch: European regulatory experience with advanced therapy medicinal products, Nat Rev Drug Discov. 2018 Nov 30. doi: 10.1038/nrd.2018.200. [Epub ahead of print]

Bec G.Strecenski I.Castelnovo T.MAH compliance with post-authorisation obligations in the European Union: a five year reviewRegulatory Rapporteur - Vol 15No 11: 27-32

Bernabe RDLCvan Thiel GJMWBreekveldt NSGispen-de Wied CCvan Delden JJMEthics in clinical trial regulation: ethically relevant issues from EMA inspection reports2008 to 2012Curr Med Res Opin. 2018 Oct 29:1-9. doi: 10.1080/03007995.2018.1528214. [Epub ahead of print]

Bhattacharyya A, Gallo P, Crisp A, LaVange L, Molenberghs G, Pétavy F, Seltzer JThe changing landscape of data monitoring committees - Perspectives from regulatorsmembers and sponsorsBiom J. 2018 Dec 27. doi: 10.1002/bimj.201700307. [Epub ahead of print]

Blind E.Janssen H.Dunder K.de Graeff P.A.The European Medicines Agency's approval of new medicines for type 2 diabetesDiabetes Obes Metab2018 May 8. doi: 10.1111/dom.13349. [Epub ahead of print]

Borysowski JSaxena ABateman-House APapaluca MRóżyńska JWnukiewicz-Kozłowska AGórski AExpanded access: growing importance to public healthJ Epidemiol Community Health. 2018 Jul;72(7):557-558. doi: 10.1136/jech-2017-210409. Epub 2018 Apr 7.

CerretaF.PadrãoA.Skibicka-StepienI. et al.Medicines for older people. Assessment and transparency at the European Medicines Agency regarding cardiovascular and antithrombotic medicinal productsEur Geriatr Med (2018) 9: 415. https://doi.org/10.1007/s41999-018-0071-1

Cilia MRuiz SRichardson PSalmonson TSerracino-Inglott AWirth FBorg JJQuality Issues Identified During the Evaluation of Biosimilars by the European Medicines Agency's Committee for Medicinal Products for Human UseAAPS PharmSciTech. 2018 Feb;19(2):489-511

Collignon OKoenig FKoch AHemmings RJPétavy FSaint-Raymond APapaluca-Amati MPosch MAdaptive designs in clinical trials: from scientific advice to marketing authorisation to the European Medicine AgencyTrials. 2018 Nov 20;19(1):642. doi: 10.1186/s13063-018-3012-x

Collignon OPétavy F.Statistical considerations about the design and endpoints of randomized clinical trials for children with irritable bowel syndrome. Neurogastroenterol Motil. 2018 May;30(5):e13266

Day SJonker AHLau LPLHilgers RDIrony ILarsson KRoes KCStallard NRecommendations for the design of small population clinical trialsOrphanet J Rare Dis. 2018 Nov 6;13(1):195. doi: 10.1186/s13023-018-0931-2

Ecker A, Mariz S, Naumann-Winter F, Norga K, Barisic I, Girard T, Tomasi P, Mentzer D, Sepodes BComparative analysis of the scope of European Union paediatric investigation plans with corresponding orphan designationsArch Dis Child. 2018 May;103(5):427-430. doi: 10.1136/archdischild-2017-313352. Epub 2017 Oct 31

Eichler HGBarker RBedlington NBouvy JCBroekmans AWBucsics ACerreta FCorriol-Rohou SGranados ALe Cam YSchuurman A.The evolution of adaptiveness: balancing speed and evidence. Nat Rev Drug Discov. 2018 Jul 6. doi: 10.1038/nrd.2018.90. [Epub ahead of print]

Eichler HGBedlington NBoudes MBouvy JCBroekmans AWCerreta FFaulkner SDForda SJoos ALe Cam YMayer MPirard VCorriol-Rohou S; ADAPT SMART Consortium.Medicines Adaptive Pathways to Patients: Whywhen and how to engage?.Clin Pharmacol Ther. 2018 Jun 14. doi: 10.1002/cpt.1121. [Epub ahead of print]

Eichler HGBloechl-Daum BBroich KKyrle PAOderkirk JRasi GSantos Ivo RSchuurman ASenderovitz TSlawomirski LWenzl MParis V. Data RichInformation Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?Clin Pharmacol Ther. 2019 Apr;105(4):912-922. doi: 10.1002/cpt.1226. Epub 2018 Oct 14

Eichler H.G.Sweeney F.The evolution of clinical trials: Can we address the challenges of the future? Clin Trials. 2018 Feb;15(1_suppl): 27-32.

Fregonese LGreene LHofer MMagrelli ANaumann-Winter FLarsson KSheean MStoyanova-Beninska VTsigkos SWestermark KSepodes B., Demonstrating significant benefit of orphan medicines: analysis of 15 years of experience in Europe, Drug Discov Today. 2018 Jan;23(1):90-100. doi: 10.1016/j.drudis.2017.09.010.

Gaspar NMarshall LVBinner DHerold RRousseau RBlanc PCapdeville RCarleer JCopland CKerloeguen YNorga KPacaud LSevaux MASpadoni CSterba JLigas FTaube TUttenreuther-Fischer MChioato SO'Connell MAGeoerger BBlay JYSoria JCKaye SWulff BBrugières LVassal GPearson ADJ; Members of Working Group 1 of the Paediatric Platform of ACCELERATE, 
Joint adolescent-adult early phase clinical trials to improve access to new drugs for adolescents with cancer: proposals from the multi-stakeholder platform-ACCELERATE, Ann Oncol. 2018 Mar 1;29(3):766-771. doi: 10.1093/annonc/mdy002.

Goedecke TMorales DPacurariu AKurz XResponse to Comment on `Measuring the impact of medicines regulatory interventions – Systematic review and methodological considerations`Br J Clin Pharmacol. 2018 Sep;84(9):2169-2170. doi: 10.1111/bcp.13664. Epub 2018 Jul 3.

Goedecke T.Morales D.Pacurariu A.Kurz X.Measuring the impact of medicines regulatory interventions – systematic review and methodological considerationsBr J Clin Pharmacol. 2018 Mar;84(3):419-433

Hofer MPHedman HMavris MKoenig FVetter TPosch MVamvakas SRegnstrom JAarum SMarketing authorisation of orphan medicines in Europe from 2000 to 2013Drug Discov Today. 2018 Feb;23(2):424-433. doi: 10.1016/j.drudis.2017.10.012. Epub 2017 Oct 23.

Hwang T.J.Tomasi P.A.Bourgeois F.T.Delays in completion and results reporting of trials under the Paediatric Regulation in the European Union: cohort studyPLoS Med. 2018 Mar 1;15(3)

Hwang TJTomasi PASaint-Raymond ABourgeois FTAvailability of paediatric information in European Medicines Agency approvalsLancet Child Adolesc Health. 2018 May;2(5):e9. doi: 10.1016/S2352-4642(18)30101-9. Epub 2018 Apr 12.

Ioannou FBurnsteel CMackay DKJGay CGRegulatory pathways to enable the licencing of alternatives to antibioticsBiologicals. 2018 May;53:72-75. doi: 10.1016/j.biologicals.2018.03.003. Epub 2018 Mar 31

Kondo H, Saint-Raymond AYasuda NWhat to Know About Medicines With New Active Ingredients Approved in FY 2016 / 2016 in Japan and EU: A Brief Comparison of New Medicines Approved in Japan and the EU in 2016Ther Innov Regul Sci. 2018 Mar;52(2):214-219. doi: 10.1177/2168479017720248. Epub 2017 Jul 21.

Kurz X.Perez‐Gutthann S.ENCePP Steering GroupStrengthening standardstransparencyand collaboration to support medicine evaluation: Ten years of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP)Pharmacoepidemiol Drug Saf. 2018;1-11.

Kälviäinen R.Straus S.Dogne J.M.Bakchine S.Haas M.Reducing valproate use in women with epilepsyThe Lancet Neurology Volume 17 Issue 7 580-581

Lim RLee DKSabourin PFerguson JMetcalf MSmith MCorriol-Rohou SEichler HGLumpkin MHirsch GChen IMO'Rourke BSchiel ACrabb NAronson NPezalla EBoutin MBinder LWilhelm LRecognizing that Evidence is MadeNot BornClin Pharmacol Ther. 2018 Nov 25. doi: 10.1002/cpt.1317. [Epub ahead of print]

Marshall SMadabushi RManolis EKrudys KStaab ADykstra KVisser SAGModel-informed Drug Discovery and Development (MID3): Current Industry Good Practice & Regulatory Expectations and Future PerspectivesCPT Pharmacometrics Syst Pharmacol. 2018 Nov 8. doi: 10.1002/psp4.12372. [Epub ahead of print]

Mazzaglia G.Straus S.M.J.Arlett P.da Silva D.Janssen H.Raine J.Alteri E.Study Design and Evaluation of Risk Minimization Measures: A Review of Studies Submitted to the European Medicines Agency for CardiovascularEndocrinologyand Metabolic DrugsDrug Saf. 2018 Feb;41(2): 191-202

McCarthy D.Bahri P.Barnes J.Delumeau J.C.Edwards B.Harrison-Woolrych M.An Update on ISoP Special Interest Groups (SIGs)Drug Saf. 2018 Jan;41(1): 1-6

Moellenhoff KDette HKotzagiorgis EVolgushev SCollignon O.Regulatory assessment of drug dissolution profiles comparability via maximum deviation. Statistics in Medicine. 2018;1–14.

Morales D.R.Slattery J.Evans S.Kurz X.Antidepressant use during pregnancy and risk of autism spectrum disorder and attention deficit hyperactivity disorder: systematic review of observational studies and methodological considerationsBMC Med. 2018 Jan 15;16(1):6

Morales D.R.Slattery J.Pinheiro L.Kurz X.Hedenmalm K.Indications for Systemic Fluoroquinolone Therapy in Europe and Prevalence of Primary Care Prescribing in FranceGermany and the UK: Descriptive Population Based StudyClin Drug Investig.2018 Aug 24. doi: 10.1007/s40261-018-0684-7 [Epub ahead of print]

Morales DRSlattery JPacurariu APinheiro LMcGettigan PKurz X. Relative and Absolute Risk of Tendon Rupture with Fluoroquinolone and Concomitant Fluoroquinolone/Corticosteroid Therapy: Population-Based Nested Case-Control StudyClin Drug Investig. 2019 Feb;39(2):205-213. doi: 10.1007/s40261-018-0729-y.

Newbould VLe Meur SGoedecke TKurz XCorrection to: Medication Errors – a characterisation of spontaneously reported cases in EudraVigilanceDrug Saf. 2018 Dec;41(12):1439-1440. doi: 10.1007/s40264-018-0700-0

Nordenmalm S.Tomasi P.Pallidis C.More medicines for children - impact of the EU Paediatric RegulationArch Dis Child. 2018 Feb 28. pii: archdischild-2017-313309. doi: 10.1136/archdischild-2017-313309. [Epub ahead of print]

O'Connor DJSheean MEHofer MPTsigkos SMariz SFregonese LLarsson KHivert VWestermark KNaumann-Winter FStoyanova-Beninska VBarišić ICapovilla GMagrelli ASepodes BDefining orphan conditions in the context of the European orphan regulation: challenges and evolutionNat Rev Drug Discov. 2019 Mar 22. doi: 10.1038/nrd.2018.128. [Epub ahead of print]

O'Sullivan JPonzano SBonelli MSafety Pharmacology Study Results and their Impact on the Design of First-in-human Trials for Authorised Oncology TherapiesPharmaceutical Medicine32(5)335-3412018

Ollivier CMulugeta YLRuggieri LSaint-Raymond AYao LPaediatric extrapolation: A necessary paradigm shiftBr J Clin Pharmacol. 2019 Apr;85(4):675-679. doi: 10.1111/bcp.13809. Epub 2018 Dec 18

Pacurariu A.Plueschke K.McGettigan P.et al.Electronic healthcare databases in Europe: descriptive analysis of characteristics and potential for use in medicines regulationBMJ Open 2018;8:e023090. doi: 10.1136/bmjopen-2018-023090

Pacurariu A.Plueschke K.Olmo C.A.Kurz X.Imposed registries within the European postmarketing surveillance system: Extended analysis and lessons learned for regulatorsPharmacoepidemiol Drug Saf. 2018 May 11. doi: 10.1002/pds.4449 [Epub ahead of print]

Pacurariu ACHoeve CEArlett PGenov GSlattery JSturkenboom MCJMStraus SMJMIs patient exposure pre and post-approval a determinant of the timing and frequency of occurrence of safety issues?Pharmacoepidemiol Drug Saf. 2018 Feb;27(2):168-173

Pelfrene E, Mura M, Cavaleiro Sanches A, Cavaleri MMonoclonal antibodies targeting infectious agents: a promising future?Clin Microbiol Infect. 2019 Jan;25(1):60-64. doi: 10.1016/j.cmi.2018.04.024. Epub 2018 Apr 30.

Peschel WMonedero Alvarez BHarmonised European standards as basis for the safe use of herbal medicinal products and their marketing authorisation in EU member statesPharmaceutical Medicine; August 2018Volume 32Issue 4,  pp 275–293

Pinheiro LCCandore GZaccaria CSlattery JArlett PAn algorithm to detect unexpected increases in frequency of reports of adverse events in EudraVigilancePharmacoepidemiol Drug Saf. 2018 Jan;27(1):38-45

Plueschke K.McGettigan P.Pacurariu A.Kurz X.Cave A.EU-funded initiatives for real world evidence: descriptive analysis of their characteristics and relevance for regulatory decision-makingBMJ Open. 2018 Jun 14;8(6)

Pomba CCatry BEdo JTJukes HLicensing and Approval of Antimicrobial Agents for Use in AnimalsMicrobiol Spectr. 2018 Aug;6(4). doi: 10.1128/microbiolspec.ARBA-0016-2017.

Postigo R.Brosch S.Slattery J.van Haren A.Dogné J.M.Kurz X.Candore G.Domergue F.Arlett P.EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health ProtectionDrug Saf. 2018 Mar 9. doi: 10.1007/s40264-018-0647-1. [Epub ahead of print]

Ponzano SBlake KBonelli MEnzmann H; European Medicines Agency Committee for Human Medicinal Products “First-in-Human Guideline Drafting Group”Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory PerspectiveClin Pharmacol Ther. 2018 Apr;103(4):564-566;

Ponzano SNigrelli GFregonese LEichler IBertozzi FBandiera TGalietta LJVPapaluca MA European regulatory perspective on cystic fibrosis: current treatmentstrends in drug development and translational challenges for CFTR modulatorsEur Respir Rev. 2018 Apr 13;27(148). pii: 170124. doi: 10.1183/16000617.0124-2017. Print 2018 Jun 30.

Postmus D.Richard S.Bere N.van Valkenhoef G.Galinsky J.Low E.Moulon I.Mavris M.Salmonsson T.Flores B.Hillege H.Pignatti F.Individual Trade-Offs Between Possible Benefits and Risks of Cancer Treatments: Results from a Stated Preference Study with Patients with Multiple Myeloma.Oncologist. 2018 Jan;23(1):44-51

Sharma RAFumi LAudisio RADenys AWood BJPignatti FCommentary: How will interventional oncology navigate the "valleys of death" for new medical devices?Br J Radiol. 2018 Feb;91(1083):20170643

Sheean ME, Stoyanova-Beninska V, Capovilla G, Duarte DHofer MP, Hoffmann M, Magrelli A, Mariz S, Tsigkos S, Shaili E, Polsinelli B, Ricciardi M, Bonelli M, Balabanov P, Larsson K, Sepodes BNonclinical data supporting orphan medicinal product designations: lessons from rare neurological conditionsDrug Discov Today. 2018 Jan;23(1):26-48

Slattery J.Morales D.Pinheiro L.Kurz X.,Cohort Study of Psychiatric Adverse Events Following Exposure to Levonorgestrel-Containing Intrauterine Devices in UK General PracticeDrug Saf. 2018 May 21. doi: 10.1007/s40264-018-0683-x. [Epub ahead of print]

Slikker W Jrde Souza Lima TAArchella Dde Silva JB JuniorBarton-Maclaren TBo LBuvinich DChaudhry QChuan PDeluyker HDomselaar GFreitas MHardy BEichler HGHugas MLee KLiao CDLoo LHOkuda HOrisakwe OEPatri ASactitono CShi LSilva PSistare FThakkar STong WValdez MLWhelan MZhao-Wong AEmerging technologies for food and drug safetyRegul Toxicol Pharmacol. 2018 Oct;98:115-128. doi: 10.1016/j.yrtph.2018.07.013. Epub 2018 Jul 23.

Smith LEHHellström AStahl AFielder AChambers WMoseley JToth CWallace DDarlow BAAranda JVHallberg BDavis JM; Retinopathy of Prematurity Workgroup of the International Neonatal ConsortiumDevelopment of a Retinopathy of Prematurity Activity Scale and Clinical Outcome Measures for Use in Clinical TrialsJAMA Ophthalmol. 2018 Dec 13. doi: 10.1001/jamaophthalmol.2018.5984. [Epub ahead of print]

Smith M.Y.Russell A.Bahri P.Mol P.G.M.Frise S.Freeman E.Morrato E.H.The RIMES Statement: A Checklist to Assess the Quality of Studies Evaluating Risk Minimization Programs for Medicinal ProductsDrug Saf. 2018 Apr;41(4):389-4

Suarez-Sharp SCohen MKesisoglou FAbend AMarroum PDelvadia PKotzagiorgis ELi MNordmark ABandi NSjögren EBabiskin AHeimbach TKijima SMandula HRaines KSeo PZhang XApplications of clinically relevant dissolution testing:  workshop summary reportAAPS J. 2018 Aug 27;20(6):93. doi: 10.1208/s12248-018-0252-3

Sullivan JOBlake KBerntgen MSalmonson TWelink J; Pharmacokinetics Working PartyOverview of the European Medicines Agency's Development of Product-Specific Bioequivalence GuidelinesClin Pharmacol Ther. 2018 Sep;104(3):539-545. doi: 10.1002/cpt.957. Epub 2018 Jan 9.

Tacconelli ECarrara ESavoldi AHarbarth SMendelson MMonnet DLPulcini CKahlmeter GKluytmans JCarmeli YOuellette MOutterson KPatel JCavaleri MCox EMHouchens CRGrayson MLHansen PSingh NTheuretzbacher UMagrini N; WHO Pathogens Priority List Working GroupDiscovery, researchand development of new antibiotics: the WHO priority list of antibiotic-resistant bacteria and tuberculosisLancet Infect Dis. 2018 Mar;18(3):318-327

Tafuri G.Lucas I.Estevão S.Moseley J.d'Andon A.Bruehl H.Gajraj E.Garcia S.Hedberg N.Massari M.Molina A.Obach M.Osipenko L.Petavy F.Petschulies M.Pontes C.Russo P.Schiel A.Van de Casteele M.Zebedin-Brandl E.M.Rasi G.Vamvakas S.The impact of parallel regulatory-HTA scientific advice on clinical development. Assessing the uptake of regulatory and HTA recommendationsBr J Clin Pharmacol. 2018 Jan 25. doi: 10.1111/bcp.13524.

Thanarajasingam GMinasian LMBaron FCavalli FDe Claro RADueck ACEl-Galaly TCEverest NGeissler JGisselbrecht CGribben JHorowitz MIvy SPJacobson CAKeating AKluetz PGKrauss AKwong YLLittle RFMahon FXMatasar MJMateos MVMcCullough KMiller RSMohty MMoreau PMorton LMNagai SRule SSloan JSonneveld PThompson CATzogani Kvan Leeuwen FEVelikova GVilla DWingard JRWintrich SSeymour JFHabermann TMBeyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignanciesLancet Haematol. 2018 Nov;5(11):e563-e598. doi: 10.1016/S2352-3026(18)30051-6. Epub 2018 Jun 18.

Tsigkos SHofer MPSheean MEMariz SLarsson KNaumann-Winter FFregonese LSepodes BEstablishing rarity in the context of orphan medicinal product designation in the European UnionDrug Discov Today. 2018 Mar;23(3):681-686

Tzogani KPenninga ESchougaard Christiansen MLHovgaard DSarac SBCamarero Jimenez JGarcia ILafuente MSancho-López ASalmonson TGisselbrecht CPignatti F, EMA Review of Daratumumab for the Treatment of Adult Patients with Multiple MyelomaOncologist. 2018 May;23(5):594-602. doi: 10.1634/theoncologist.2017-0328. Epub 2018 Jan 25

Tzogani Kvan Hennik PWalsh IDe Graeff PFolin ASjöberg JSalmonson TBergh JLaane ELudwig HGisselbrecht CPignatti FThe European Medicines Agency Review of Panobinostat (Farydak) for the Treatment of Adult Patients with Relapsed and/or Refractory Multiple MyelomaOncologist. 2018 May;23(5):631-636. doi: 10.1634/theoncologist.2017-0301. Epub 2017 Nov 30. Erratum in: Oncologist. 2018 Jul;23(7):870.

van Gerven JBonelli MCommentary on the EMA Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal productsBr J Clin Pharmacol. 2018 Jul;84(7):1401-1409. doi: 10.1111/bcp.13550. Epub 2018 May 30

Vannice KSWilder-Smith ABarrett ADTCarrijo KCavaleri Mde Silva ADurbin APEndy THarris EInnis BLKatzelnick LCSmith PGSun WThomas SJHombach JClinical development and regulatory points for consideration for second-generation live attenuated dengue vaccinesVaccine. 2018 Jun 7;36(24):3411-3417. doi: 10.1016/j.vaccine.2018.02.062. Epub 2018 Mar 7

Vatzaki E.Straus S.Dogne H.M.Garcia Burgos J.Girard T.Martelletti P.Latest clinical recommendations on valproate use for migraine prophylaxis in women of childbearing age: overview from European Medicines Agency and European Headache FederationThe Journal of Headache and Pain (2018) 19:68

Vermeer NGiezen TZastavnik SWolff-Holz EHidalgo-Simon AIdentifiability of biologicals in ADR reports received from European clinical practiceClin Pharmacol Ther. 2018 Nov 21. doi: 10.1002/cpt.1310. [Epub ahead of print]

Aartsma-Rus A.Balabanov P.Binetti L.Haas M.Haberkamp M.Mitchell J.Mário M.R.Muntoni F.Finkel R.Mercuri E.Stakeholder collaboration for spinal muscular atrophy therapy developmentThe Lancet Neurology Vol 16(4)p. 264

Aartsma-Rus A.Straub V.Hemmings R.Haas M.Schlosser-Weber G.Stoyanova-Beninska V.Mercuri E.Muntoni F.Sepodes B.Vroom E.Balabanov P.Development of exon skipping therapies for Duchenne muscular dystrophy: a critical review and a perspective on the outstanding issuesNucleic Acid Ther. 2017 Aug 10. doi: 10.1089/nat.2017.0682. [Epub ahead of print]

Aisen PTouchon JAmariglio RAndrieu S, Bateman R, Breitner J, Donohue MDunn B, Doody R, Fox N, Gauthier S, Grundman M, Hendrix S,Ho C, Isaac M, Raman R, Rosenberg PSchindler R, Schneider L, Sperling RTariot PWelsh-Bohmer K, Weiner M, Vellas BEU/US/CTAD Task Force: Lessons Learned from Recent and Current Alzheimer's PreventionTrialsJ Prev Alzheimers Dis. 2017;4(2):116-124

Anton R.Haas M.Arlett P.Weise M.Balabanov P.Mazzaglia G.Prieto L.Keller-Stanislawski B.Raine J.Drug-induced progressive multifocal leukoencephalopathy in multiple sclerosis: European regulators' perspectiveClin Pharmacol Ther. 2016 Dec 21. doi: 10.1002/cpt.604

Bahri P.Fogd J.Morales D.Kurz X.ADVANCE consortiumApplication of real-time global media monitoring and 'derived questions' for enhancing communication by regulatory bodies: the case of human papillomavirus vaccinesBMC Med. Vol. 15(1)p. 91doi: 10.1186/s12916-017-0850-4.

Banovac MCandore GSlattery JHouÿez FHaerry DGenov GArlett PPatient reporting in the EU: Analysis of EudraVigilance dataDrug Saf. 2017 Jul;40(7):629-645

Berger M.L.Sox H.Willke R.J.Brixner D.L.Eichler H.G.Goettsch W.Madigan D.Makady A.Schneeweiss S.Tarricone R.Wang S.V.Watkins J.Daniel Mullins C.Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision makingPharmacoepidemiol Drug Saf. 2017 Sep;26(9):1033-1039. doi: 10.1002/pds.4297.

Bonini S.Rasi G.Inhibitor of Fatty Acid Amide Hydrolase - Learning from Tragic FailuresN Engl J Med.Vol. 376(4):394.

Bonini SBonini MBiosimilars and drug development in allergic and immunologic diseasesJ Allergy Clin Immunol. 2017 May;139(5):1461-1464. doi: 10.1016/j.jaci.2017.03.008. Epub 2017 Mar 27

Boráň TMenezes-Ferreira MReischl ICelis PFerry NGänsbacher BKrafft HLipucci di Paola MSladowski DSalmikangas PClinical Development and Commercialization of Advanced Therapy Medicinal Products (ATMPs) in EU: how are the product pipeline and regulatory framework evolving?Hum Gene Ther Clin Dev. 2017 Sep;28(3):126-135

Bouvy J.C.Blake K.Slattery J.De Bruin M.L.Arlett P.Kurz X.Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products2005-2013Pharmacoepidemiol Drug Saf. 2017 Mar 26.

Bueno H.de Graeff P.Richard-Lordereau I.Emmerich J.Fox K. A.Friedman C. P.Gaudin C.El-Gazayerly A.Goldman S.Hemmrich M.Henderson R. A.Himmelmann A.Irs A.Jackson N.James S. K.Katus H. A.Laslop A.Laws I.Mehran R.Ong S.Prasad K.Roffi M.Rosano G. M.Rose M.Sinnaeve P. R.Stough W. G.Thygesen K.Van de Werf F.Varin C.Verheugt F. W.de Los Angeles Alonso García M.Report of the European Society of Cardiology Cardiovascular Round Table regulatory workshop update of the evaluation of new agents for the treatment of acute coronary syndrome: Executive summaryEur Heart J Acute Cardiovasc Carepii: 2048872616649859

Collignon O.Veselý R.Should baseline-dependent cut-offs really be used to define disease improvement in juvenile idiopathic arthritis? And few other considerationsRheumatology (Oxford)Vol. 56(1)pp.165-167.

Collignon O.Veselý R.Statistical considerations in the development of clinical predictive scores: comment on the article by Domsic et alArthritis Rheumatol.Vol. 69(1)pp. 241-242. doi: 10.1002/art.39854

Cowie MRFilippatos GSAlonso Garcia MLAAnker SDBaczynska ABloomfield DMBorentain MBruins Slot KCronin MDoevendans PAEl-Gazayerly AGimpelewicz CHonarpour NJanmohamed SJanssen HKim AMLautsch DLaws ILefkowitz MLopez-Sendon JLyon ARMalik FIMcMurray JJVMetra MFigueroa Perez SPfeffer MAPocock SJPonikowski PPrasad KRichard-Lordereau IRoessig LRosano GMCSherman WStough WGSwedberg KTyl BZannad FBoulton CDe Graeff PNew medicinal products for chronic heart failure: advances in clinical trial design and efficacy assessmentEur J Heart Fail. 2017 Jun;19(6):718-727

Davis JM, Baer GR, Portman R, Nelson R, Storari L, Aranda JV, Bax R, Zajicek A, Klein A, Turner M, Baygani S, Thomson M, Allegaert K; International Neonatal ConsortiumEnrollment of Neonates in More Than One Clinical TrialClin Ther. 2017 Oct;39(10):1959-1969

De Briyne N.Gopal R.Diesel G.Iatridou D.O'Rourke D.Veterinary pharmacovigilance in Europe: a survey of veterinary practitionersVeterinary Record OpenVol. 4Issue 1: e000224. doi: 10.1136/vetreco-2017-000224.

Dunder Kde Graeff PABlind EComment on the editorial by Turner et al. on Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment versus risk aversion by Zannad et alEur Heart J Cardiovasc Pharmacother. 2017 Jul 1;3(3):129

Eichler I, Manolis EChest Imaging in CF Studies  -  CommentaryJ Cyst Fibros. 2017 Mar;16(2):173-174

Farkas AM, Mariz S, Stoyanova-Beninska V, Celis P, Vamvakas S, Larsson K, Sepodes BAdvanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in EuropeFront Med (Lausanne). 2017 May 16;4:53

Grimaldi-Bensouda L, Nordon C, Rossignol M, Jardon V, Boss V, Warembourg F, Reynolds R, Kurz X, Rouillon F, Abenhaim L; PROTECT-WP6 study groupAntiepileptic drugs and risk of suicide attempts: a case-control study exploring the impact of underlying medical conditionsPharmacoepidemiol Drug Saf. 2017 Mar;26(3):239-247

Goedecke T.Ord K.Newbould V.Brosch S.Arlett P.Medication Errors: New EU Good Practice Guide on Risk Minimisation and Error PreventionDrug Saf. 2017 Dec;40(12):1241-1248

Heininger U, Holm K, Caplanusi I, Bailey SR; CIOMS Working Group on Vaccine SafetyGuide to active vaccine safety surveillance: Report of CIOMS working group on vaccine safety - executive summaryVaccine. 2017 Jul 13;35(32):3917-3921

Isaac MB, Vamvakas SSwings and Roundabouts in CNS Drug BiomarkersJ Prev Alzheimers Dis. 2017;4(3):134-135

Isaac MT, Vamvakas S, Isaac MBDiagnostic biomarkers for Alzheimer's disease: a regulatory viewLancet Neurol. 2017 Aug;16(8):580-581

Jonsson BMartinalbo JPignatti FEuropean Medicines Agency Perspective on Oncology Study Design for Marketing Authorization and BeyondClin Pharmacol Ther. 2017 May;101(5):577-579

Kollb-Sielecka MDemolis P.Emmerich J.Markey G.Salmonson T.Haas M.The European Medicines Agency review of pitolisant for treatment of narcolepsy: summary of the scientific assessment by the Committee for Medicinal Products for Human UsesleepmedicineVol 33pp. 125-129

Kurz X.Advancing regulatory scienceadvancing regulatory practicePharmacoepidemiol Drug Saf.doi: 10.1002/pds.4181.

Kurz X, Bauchau V, Mahy P, Glismann S, van der Aa LM, Simondon F; ADVANCE consortiumThe ADVANCE Code of Conduct for Collaborative Vaccine StudiesVaccine. 2017 Apr 4;35(15):1844-1855

Landray MJBax JJAlliot LBuyse MCohen ACollins RHindricks GJames SKLane SMaggioni APMeeker-O'Connell AOlsson GPocock SJRawlins MSellors JShinagawa KSipido KRSmeeth LStephens RStewart MWStough WGSweeney FVan de Werf FWoods KCasadei BImproving public health by improving clinical trial guidelines and their applicationEur Heart J. 2017 Jun 1;38(21):1632-1637. doi: 10.1093/eurheartj/ehx086

Lombardi DSquires LSjostedt PThompson CTurner MEichler IIndustry and Patient Perspectives on Child Participation in Clinical Trials. The Pediatric Assent Initiative Survey ReportTherapeutic Innovation& Regulatory Science 2017Vol. 52 (1) 29-37

Luigetti RBachmann PCooke ESalmonson TCollaboration not Competition: Developing New Reliance ModelsWHO Drug Information Vol. 30No. 42016

Manolis EBrogren JCole SHay JLNordmark AKarlsson KELentz FBenda NWangorsch GPons GZhao WGigante VSerone FStanding JFDokoumetzidis AVakkilainen Jvan den Heuvel MMangas Sanjuan VTaminiau JKerwash EKhan DMusuamba FTSkottheim Rusten IEMA Modelling and Simulation Working GroupCommentary on the MID3 Good Practices PaperCPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):416-417. doi: 10.1002/psp4.12223. Epub 2017 Jul 22

Medem A.V.Seidling H.M.Eichler H.G.Kaltschmidt J.Metzner M.Hubert C.M.Czock D.Haefeli W.E.Definition of variables required for comprehensive description of drug dosage and clinicalpharmacokineticsEur J Clin Pharmacol. Eur J Clin Pharmacol.Vol 73(5)pp. 633-641

Moreno LCaron H, Geoerger B, Eggert A, Schleiermacher G, Brock P, Valteau-Couanet D, Chesler L, Schulte JH, De Preter K, Molenaar J, Schramm A, Eilers M, Van Maerken T, Johnsen JI, Garrett M, George SL, Tweddle DA, Kogner P, Berthold F, Koster J, Barone G, Tucker ER, Marshall L, Herold R, Sterba J, Norga K, Vassal G, Pearson ADAccelerating drug development for neuroblastoma - New Drug Development Strategy: an Innovative Therapies for Children with CancerEuropean Network for Cancer Research in Children and Adolescents and International Society of Paediatric Oncology Europe Neuroblastoma projectExpert Opin Drug Discov. 2017 Aug;12(8):801-811

MusuambaManolis EHolford NCheung SFriberg LEOgungbenro KPosch MYates JBerry SThomas NCorriol-Rohou SBornkamp BBretz FHooker ACVan der Graaf PHStanding JFHay JCole SGigante VKarlsson KDumortier TBenda NSerone FDas SBrochot AEhmann FHemmings RRusten ISAdvanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4-5 December 2014)CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):418-429. doi: 10.1002/psp4.12196. Epub 2017 Jul 19

Newbould VLe Meur SGoedecke TKurz X.Medication Errors: A Characterisation of Spontaneously Reported Cases in EudraVigilanceDrug Saf. 2017 Jul 11. doi: 10.1007/s40264-017-0569-3

Newbould VLe Meur SGoedecke TKurz XCorrection to: Medication Errors – a characterisation of spontaneously reported cases in EudraVigilanceDrug Saf. 2017 Dec;40(12):1293. doi: 10.1007/s40264-017-0609-z

Ohmann CBanzi RCanham SBattaglia SMatei MAriyo CBecnel LBierer BBowers SClivio LDias MDruml CFaure HFenner MGalvez JGhersi DGluud CGroves THouston PKaram GKalra DKnowles RLKrleža-Jerić KKubiak CKuchinke WKush RLukkarinen AMarques PSNewbigging AO'Callaghan JRavaud PSchlünder IShanahan DSitter HSpalding DTudur-Smith Cvan Reusel Pvan Veen EBVisser GRWilson JDemotes-Mainard JSharing and reuse of individual participant data from clinical trials: principles and recommendationsBMJ Open. 2017 Dec 14;7(12)

Pauwels K.Huys I.Casteels M.Larsson K.Voltz C.Penttila K.More T.Simoens S.Are products with an orphan designation for oncology indications different from products for other rare indications? A retrospective analysis of European orphan designations granted between 2002-2012Orphanet Journal of Rare Diseasesdoi: 10.1186/s13023-017-0578-4

Penkov DTomasi PEichler IMurphy DYao LPTemeck JPediatric Medicine Development: An Overview and Comparison of Regulatory Processes in the European Union and United StatesTherapeutic Innovation & Regulatory Science 2017Vol. 51(3) 360-371

Polsinelli B, Tsigkos S, Naumann-Winter F, Mariz S, Sepodes BEvolving prevalence of haematological malignancies in orphan designation procedures in the European UnionOrphanet J Rare Dis. 2017 Jan 21;12(1):17

Pomba C.Rantala M.Greko C.Baptiste K. E.Catry B.van Duijkeren E.Mateus A.Moreno M. A.Pyörälä S.Ružauskas M.Sanders P.Teale C.Threlfall E. J.Kunsagi Z.Torren-Edo J.Jukes H.Törneke K.Public health risk of antimicrobial resistance transfer from companion animalsJ Antimicrob ChemotherVol. 72(4)pp. 957-968doi: 10.1093/jac/dkw481

Raimi-Abraham BTde Orbe Izquierdo MSCollignon OCerreta FRegulatory considerations on the enrollment of older adults in oncology clinical trialsJ Geriatr Oncol. 2017 May; 8(3):151-153. doi: 10.1016/j.jgo.2017.02.006Epub 2017 Mar 9

Rohner EGrabik MTonia TJüni PPétavy FPignatti FBohlius JDoes access to clinical study reports from the European Medicines Agency reduce reporting biases? A systematic review and meta-analysis of randomized controlled trials on the effect of erythropoiesis-stimulating agents in cancer patientsPLoS One. 2017 Dec 11;12(12)

Salmonson T.Dogné J. M.Janssen H.Garcia Burgos J.Blake P.Non-vitamin-K oral anticoagulants and laboratory testing: now and in the future: Views from a workshop at the European Medicines Agency (EMA)Eur Heart J Cardiovasc Pharmacother.Vol. 3(1)pp. 42–47.

Santoro AGenov GSpooner ARaine JArlett P.Promoting and Protecting Public Health: How the European Union Pharmacovigilance System WorksDrug Saf. 2017 Jul 22. doi: 10.1007/s40264-017-0572-8

Stanel SCSjöberg JSalmonson TFoggi PCaleno MMelchiorri DGravanis ITzogani KPignatti FEuropean Medicines Agency Approval Summary: Zaltrap For The Treatment Of Patients With Oxaliplatin-Resistant Metastatic Colorectal CancerESMO Open. 2017 May 2;2(2):e000190

Stefanska A.M.Distlerová D.Musaus J.Olski T.M.Dunder K.Salmonson T.Mentzer D.Müller-Berghaus J.Hemmings R.Veselý R.Extrapolation in the development of paediatric medicines: examples from approvals for biological treatments for paediatric chronic immune-mediated inflammatory diseasesArch Dis Child. 2017 May 29. pii: archdischild-2016-312259. doi: 10.1136/archdischild-2016-312259

Tomasi P.A.Egger G.F.Saint-Raymond AEnabling development of paediatric medicines in Europe: 10 years of the EU Paediatric RegulationPaediatr Drugs. 2017 Sep 12. doi: 10.1007/s40272-017-0261-1.

Tzogani K, Camarero Jiménez J, Garcia I, Sancho-López A, Martin M, Moreau A, Demolis P, Salmonson T, Bergh J, Laane E, Ludwig H, Gisselbrecht C, Pignatti FThe European Medicines Agency review of carfilzomib (Kyprolis) for the treatment of adult patients with multiple myeloma who have received at least one prior therapyOncologist. 2017 Nov;22(11):1339-1346

Veselý R.Richardson P.The switch to infliximab biosimilarsThe Lancetdoi: http://dx.doi.org/10.1016/S0140-6736(17)31258-8

Wickström K.Moseley J.Biomarkers and Surrogate Endpoints in Drug Development: A European Regulatory ViewInvest Ophthalmol Vis SciVol.58 (6)BIO27-BIO33.

Bahri P.Dodoo A. N.Edwards B. D.Edwards I. R.Fermont I.Hagemann U.Hartigan-Go K.Hugman B.Mol P. G.'The ISoP CommSIG for Improving Medicinal Product Risk Communication: A New Special Interest Group of the International Society of Pharmacovigilance'Drug Saf.Vol. 38(7)pp. 621-627

Barnes P.J.Bonini S.Seeger W.Belvisi M.G.Ward B.Holmes A.Barriers to new drug development in respiratory diseaseEur Respir J. 2015 May;45(5):1197-207. doi: 10.1183/09031936.00007915

Bartlett J. A.Brewster M.Brown P.Cabral-Lilly D.Cruz C. N.David R.Eickhoff W. M.Haubenreisser S.Jacobs A.Malinoski F.Morefield E.Nalubola R.Prud'homme R. K.Sadrieh N.Sayes C. M.Shahbazian H.Subbarao N.Tamarkin L.Tyner K.Uppoor R.Whittaker-Caulk M.Zamboni W.'Summary report of PQRI workshop on nanomaterial in drug products: current experience and management of potential risks'The AAPS JournalVol. 17(1)pp. 44-64.

Blind E.de Graeff P. A.Meurs I.Holtkamp F.Baczynska A.Janssen H.The European Medicines Agency's approval of proprotein convertase subtilisin/kexin type 9 inhibitorsEur Heart J. pii: ehv673.

Bonelli M.Di Giuseppe F.Beken S.'Impact analysis of ICH S9 on non-clinical development of anticancer drugs'Regul Toxicol Pharmacol.Vol. 73(1)pp. 361-366

Bonini M.Gramiccioni C.Fioretti D.Ruckert B.Rinaldi M.Akdis C.Todaro A.Palange P.Carlsen K.H.Pelliccia A.Rasi G.Bonini S.Asthmaallergy and the Olympics: a 12-year survey in elite athletes, AIDA and the Italian Unit of the GA2LEN Olympic StudyCurr Opin Allergy Clin Immunol. 2015 Apr;15(2):184-92. doi: 10.1097/ACI.0000000000000149

Both L.Botgros R.Cavaleri M., Analysis of licensed over-the-counter (OTC) antibiotics in the European Union and Norway2012Euro Surveill.Vol. 20(34).

Bousquet J.Kuh D.Bewick M.Standberg T.Farrell J.Pengelly R.Joel M.E.Rodriguez Mañas L.Mercier J.Bringer J.Camuzat T.Bourret R.Bedbrook A.Kowalski M.L.Samolinski B.Bonini S. et al.Operational Definition of Active and Healthy Ageing (AHA): A Conceptual FrameworkJ Nutr Health Aging. 2015 Nov;19(9):955-60. doi: 10.1007/s12603-015-0589-6

Butlen-Ducuing F.Zienowicz M.Pétavy F.Haas M.Salmonson T.Eichler H.G.Rasi G.European regulatory experience with drugs for central nervous system disordersNat Rev Drug Discov.Vol14(2)pp. 89-90.

Candore GJuhlin KManlik KThakrar BQuarcoo NSeabroke SWisniewski ASlattery JComparison of statistical signal detection methods within and across spontaneous reporting databasesDrug Saf. 2015 Jun;38(6):577-87

Catry B.Cavaleri M.Baptiste K.Grave K.Grein K.Holm A.Jukes H.Liebana E.Lopez Navas A.Mackay D.Magiorakos A. P.Moreno Romo M. A.Moulin G.Muñoz Madero C.Matias Ferreira Pomba M. C.Powell M.Pyörälä S.Rantala M.Ružauskas M.Sanders P.Teale C.Threlfall E. J.Törneke K.van Duijkeren E.Torren Edo J.Use of colistin-containing products in animals within the European Union and European Economic Area (EU/EEA): development of resistance and possible impact on human and animal healthInt J Antimicrob AgentsVol 46(3)pp. 297-306.

Cavaleri MManolis EHollow Fibre System Model for Tuberculosis: The European Medicines Agency ExperienceClin Infect Dis. 2015 Aug 15;61 Suppl 1:S1-4.

Celis PFerry NHystad MSchüßler-Lenz MDoevendans PAFlory EBeuneu CReischl ISalmikangas PAdvanced Therapy Medicinal Products – How to bring cell-based medicinal products successfully to the market. Report from the CAT-DGTI-GSCN workshop at the DGTI Annual Meeting 2014Transfus Med Hemother. 2015 May;42(3):194-9

Cohen J.Vincent J. L.Adhikari N. K. J.Machado F. R. Angus D. C.Calandra T.Jaton K.Giulieri S.Delaloye J.Opal S.Tracey K.van der Poll T.Pelfrene E.'Sepsis: a roadmap for future research'Lancet Infect Dis.doi: http://dx.doi.org/10.1016/S1473-3099(15)70112-X

Dal Pan G. J.Arlett P. R.'The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges'Drug Saf.Vol. 38pp. 13-15.

Dodt J.Hubbard A. R.Wicks S. J.Gray E.Neugebauer B.Charton E.Silvester G.'Potency determination of factor VIII and factor IX for new product labelling and postinfusion testing: challenges for caregivers and regulators'Haemophiliadoi: 10.1111/hae.12634.

Dreyer NABlackburn SHliva VMt-Isa SRichardson JJamry-Dziurla ABourke AJohnson RBalancing the interests of patient data protection and medication safety monitoring in a public-private partnershipJMIR Med Inform. 2015 Apr 15;3(2):e18. doi: 10.2196/medinform.3937.

Dreyer NABlackburn SCMt-Isa SRichardson JLThomas SLaursen MZetstra-van der Woude PJamry-Dziurla AHliva VBourke Ade Jong-van den Berg LDirect-to-Patient Research: Piloting a New Approach to Understanding Drug Safety During PregnancyJMIR Public Health Surveill. 2015 Dec 22;1(2):e22. doi: 10.2196/publichealth.4939. eCollection 2015 Jul-Dec.

Ehmann F.Caneva L.Prasad K.Paulmichl M.Maliepaard M.Llerena A.Ingelman-Sundberg M.Papaluca-Amati M.'Pharmacogenomic information in drug labels: European Medicines Agency perspective'Pharmacogenomics J. 2015 Jun;15(3):201-10

Ehmann F.Papaluca M.Di Giuseppe F.Pani L.Eskova A.Manolis E.Herold R.'Changes and determination of dosing recommendations for medicinal products recently authorised in the European Union'Expert Opin PharmacotherVol.16(6)pp. 903-11.

Eichler H. G.Baird L.Barker R.Bloechl-Daum B.Børlum-Kristensen F.Brown J.Chua R.Del Signore S.Dugan U.Ferguson J.Garner S.Goettsch W.Haigh J.Honig P.Hoos A.Huckle P.Kondo T.Le Cam Y.Leufkens H.Lim R.Longson C.Lumpkin M.Maraganore J.O'Rourke B.Oye K.Pezalla E.Pignatti F.Raine J.Rasi G.Salmonson T.Samaha D.Schneeweiss S.Siviero P.Skinner M.Teagarden J.Tominaga T.Trusheim M.Tunis S.Unger T.Vamvakas S.Hirsch G.'From adaptive licensing to adaptive pathways: delivering a flexible life span approach to bring new drugs to patients'Clin Pharmacol Ther.Vol. 97(3)pp. 234-46.

Eichler H.GThomson A.Eichler I.Schneeweiss S.'Assessing the relative efficacy of new drugs: an emerging opportunity'Nature Reviews Drug DiscoveryVol. 14pp. 443–444.

Flory EGasparini PJekerle VPalomäki TCelis PBoráň TMcBlane JWBorg JJKyselovic JLipnik–Stangelj MMaimets TMenezes-Ferreira MPante GPrilla SRiekstina USchneider CKTsiftsoglou ASalmikangas PRegulatory viewpoints on the development of advanced stem cell–based medicinal products in light of the first EU-approved stem cell productCell Gene Therapy Insights 2015; 1(1)109-127.

Fregonese LEichler IThe future of the development of medicines in idiopathic pulmonary fibrosisBMC Med. 2015 Sep 24;13:239

Goldman M.Seigneuret N.Eichler H. G.'The Innovative Medicines Initiative: An engine for regulatory science'Nat Rev Drug Discov.Vol. 14(1)pp.1-2

Haas M.Mantua V.Haberkamp M.Pani L.Isaac M.Butlen-Ducuing F.Vamvakas S.Broich K.The European Medicines Agency's strategies to meet the challenges of Alzheimer diseaseNat Rev Drug Discov. 2015 Apr;14(4):221-2. doi: 10.1038/nrd4585

Haas M.Vlcek V.Balabanov P.Salmonson T.Bakchine S.Markey G.Weise M.Schlosser-Weber G.Brohmann H.Yerro C. P.Mendizabal M. R.Stoyanova-Beninska V.Hillege H. L.'The European Medicines Agency review of ataluren for the treatment of ambulant patients aged 5 years and older with Duchenne muscular dystrophy resulting from a nonsense mutation in the dystrophin gene: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use'Neuromuscul Disord. Vol. 25(1)pp.5-13

Hanaizi Z.Flores B.Hemmings R.Camarero J.Sancho-Lopez A.Salmonson T.Gisselbrecht C.Laane E.Pignatti F.,' The European Medicines Agency review of pomalidomide for the treatment of adult patients with multiple myeloma: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use'OncologistVol. 20(3)pp. 329-334.

Haubenreisser s.Harvey-Allchurch M.Chapter 3 - The European Medicines Agency and the Regulation of Medicines in the European UnionFood and Drug Regulation in an Era of Globalised Marektspp. 25-36.

Hofer M.P.Jakobsson C.Zafiropoulos N.Vamvakas S.Vetter T.Regnstrom J.Hemmings R.J.Regulatory watch: Impact of scientific advice from the European Medicines AgencyNature Reviews Drug DiscoveryVol 14(5)pp. 302-303.

Huerta CAbbing-Karahagopian VRequena GOliva BAlvarez YGardarsdottir HMiret MSchneider CGil MSouverein PCDe Bruin MLSlattery JDe Groot MCHesse URottenkolber MSchmiedl SMontero DBate ARuigomez AGarcía-Rodríguez LAJohansson Sde Vries FSchlienger RGReynolds RFKlungel OHde Abajo FJ(included in 2014 report under incorrect title)Pharmacoepidemiol Drug Saf. 2015 Jul 7        

Klug B.Celis P.Ruepp R.Robertson J S.EU regulatory guidelines for the clinical evaluation of adjuvantsClin Res Pr Drug Regul Affdoi:10.3109/10601333.2015.1001899

Koenig F.Slattery S.Groves T.Lang T.Benjamini Y.Day S.Bauer P.and Posch M.Sharing clinical trial data on patient level: Opportunities and challengesBiometrical Journal 578-26(2015) [bib]

Krause P. R.Cavelari M.Coleman G.Gruber M. F.Approaches to Demonstration of Ebola Virus Vaccine EfficacyLancetVo. 15(6)pp. 615-746.

Loth E.Spooren W.Ham L. M.Isaac M. B.Auriche-Benichou C.Banaschewski T.Baron-Cohen S.Broich K.Bölte S.Bourgeron T.Charman T.Collier D.de Andres-Trelles F.Durston S.Ecker C.Elferink A.Haberkamp M.Hemmings R.Johnson M. H.Jones E. J.Khwaja O. S.Lenton S.Mason L.Mantua V.Meyer-Lindenberg A.Lombardo M. V.O'Dwyer L.Okamoto K.Pandina G. J.Pani L.Persico A. M.Simonoff E.Tauscher-Wisniewski S.Llinares-Garcia J.Vamvakas S.Williams S.Buitelaar J. K.Murphy D. G.Identification and Validation of Biomarkers for Autism Spectrum DisordersNat Rev Drug Discov. Vol 15(1)pp. 70-3.

Luciani F.Galluzzo S.Gaggioli A.Kruse N. A.Venneugues P.Schneider C. K.Pini C.Melchiorri D.Implementing quality by design for biotech products: are regulators on track?Vol 7(3)pp. 451-455

Luigetti R.Cooke E.Cuddy B.Goux S.Rees I.GMP Oversight of Medicines Manufacturers in the European UnionPDA Letter

Murray S.McKenna L.Pelfrene E.Botgros R.Accelerating clinical drug development for children with tuberculosisInternational Journal of Tuberculosis and Lung Disease.2015 Dec;19 Suppl 1pp. 69-74.

Nachman S.Ahmed A.Amanullah F.Becerra M. C.Botgros R.Brigden G.Browning R.Gardiner E.Hafner R.Hesseling A.How C.Jean-Philippe P.Lessem E.Makhene M.Mbelle N.Marais B.McIlleron H.McNeeley D. F.Mendel C.Murray S.Navarro E.Anyalechi E. G.Porcalla A. R.Powell C.Powell M.Rigaud MRouzier V.Samson P.Schaaf H. S.Shah S.Starke J.Swaminathan S.Wobudeya E.Worrell C.Towards early inclusion of children in tuberculosis drugs trials: a consensus statementLancet Infect Dis.Vol. 15(6)pp. 711–720.

Norga KKKankergeneesmiddelen voor kinderen: impact van de Europese “Paediatric Regulation”

Offringa M.Davis J.M.Turner M.A.Ward R.Bax R.Maldonado S.Sinha V.McCune S.K.Zajicek A.Benjamin D.K.Bucci-Rechtsweg C.Nelson R.M.Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific WorkshopOctober 28-292014Therapeutic Innovation & Regulatory Science7 August 2015

Oye K.A.Pearson M.Eichler H.G.Mullin T.Hoos A.Managing uncertainty in drug development and use informed regulation: Enhancing adaptability and flexibility in pharmaceuticals regulation. In: Improving Risk RegulationInternational Risk Governance Council (IRGC). Lausanne: IRGC2015 (63-80).

Pacurariu A.C.Straus S.M.Trifirò G.Schuemie M.J.Gini R.Herings R.Mazzaglia G.Picelli G.Scotti L.Pedersen L.Arlett P.Van der Lei J.Sturkenboom M.C.Coloma P.M.Useful Interplay Between Spontaneous ADR Reports and Electronic Healthcare Records in Signal DetectionDrug Saf.doi:10.​1007/​s40264-015-0341-5doi:10.1586/17512433.2015.1028918

Pani LPecorelli SRosano GAnker SDPeracino AFregonese LPrasad KRasi GSteps Forward In Regulatory Pathways For Acute and Chronic Heart FailureEur J Heart Fail. 2015 Jan;17(1):3-8. doi: 10.1002/ejhf.209.

Papaluca M.Grecoa M.Tognana E.Ehmann F.Saint-Raymond A.White spots in pharmaceutical pipelines–EMA identifies potential areas of unmet medical needsExpert Review of Clinical PharmacologyVol.8Issue 32015

Pelfrene E.Pinheiro M. H.Cavaleri M.'Artemisinin-based combination therapy in the treatment of uncomplicated malaria: review of recent regulatory experience at the European Medicines Agency'Int Healthdoi: 10.1093/inthealth/ihv017.

Pignatti F.Ashby D.Brass E. P.Eichler H. G.Frey P.Hillege H. L.Hori A.Levitan B.Liberti L.Löfstedt R. E.McAuslane N.Micaleff A.Noel R. A.Postmus D.Renn O.Sabourin B. J.Salmonson T.Walker S.Structured Frameworks to Increase the Transparency of the Assessment of Benefits and Risks of Medicines: Current Status and Possible Future DirectionsVol. 98(5)pp. 522-33.

Radawski CMorrato EHornbuckle KBahri PSmith MJuhaeri JMol PLevitan BHuang H-YCoplan PLi H (on behalf of the ISPE BRACE SIG)Benefit-Risk AssessmentCommunication and Evaluation (BRACE) throughout the Life Cycle of Therapeutic Products: Overall Perspective and Role of the PharmacoepidemiologistPharmacoepidemiol Drug Saf. 2015; 24: 1233-1240

Rasi G.Bonini S.Innovative medicines: new regulatory procedures for the third millenniumExpert Opin Biol Ther. 2015;15 Suppl 1:S5-8. doi: 10.1517/14712598.2015.1026322

Roca IAkova MBaquero FCarlet JCavaleri MCoenen SCohen JFindlay DGyssens IHeure OEKahlmeter GKruse HLaxminarayan RLiébana ELópez-Cerero LMacGowan AMartins MRodríguez-Baño JRolain JMSegovia CSigauque BTaconelli EWellington EVila JThe global threat of antimicrobial resistance: science for interventionNew Microbes New Infect. 2015 Apr 16;6:22-9.

Romero KIto KRogers JPolhamus DQiu RStephenson DMohs RLalonde RSinha VWang YBrown DIsaac MVamvakas SHemmings RPani LBain LjCorrigan B; Alzheimer's Disease Neuroimaging Initiative for the Coalition Against Major DiseasesThe Future Is Now:  Model-Based Clinical Trial Design for Alzheimer’s DiseaseClin Pharmacol Ther. 2015 Mar;97(3):210-4.

Rottenkolber M.Voogd E.van Dijk L.Primatesta P.Becker C.Schlienger R.de Groot M. C.Alvarez Y.Durand J.Slattery J.Afonso A.Requena G.Gil M.Alvarez A.Hesse U.Gerlach R.Hasford J.Fischer R.Klungel O. H.Schmiedl S.'Time trends of period prevalence rates of patients with inhaled long-acting Beta-2-agonists-containing prescriptions: a European comparative database study'PLoS OneVol.10(2):e0117628.

Rottenkolber MVoogd Evan Dijk LPrimatesta PBecker Cde Groot MCPlana EAlvarez YDurand JSlattery JAfonso ARequena GHuerta CAlvarez Ade Abajo FTauscher MHasford JFischer RReynolds RSchmiedl SSeasonal changes in prescribing of long-acting beta-2-agonists-containing drugsRespir Med. 2015 Jul;109(7):828-37

Sabaté MFerrer PBallarín ERottenkolber MAmelio JSchmiedl SReynolds RKlungel OIbáñez L; PROTECT Work Package 2Inpatient drug utilization in Europe: nationwide data sources and a review of publications on a selected group of medicines (PROTECT project)Basic Clin Pharmacol Toxicol. 2015 Mar;116(3):201-11. doi: 10.1111/bcpt.12358. Epub 2014 Dec 29.

Salmikangas P.Menezes-Ferreira M.Reischl I.Tsiftsoglou A.Kyselovic J.Borg J. J.Ruiz S.Flory E.Trouvin J. H.Celis P.Ancans J.Timon M.Pante G.Sladowski D.Lipnik-Stangelj M.Schneider C. K.'Manufacturingcharacterisation and control of cell-based medicinal products: challenging paradigms towards commercial use'Regen. Med.Vol. 10(1)pp. 65-78.

Salmikangas PSchuessler-Lenz MRuiz SCelis PReischl IMenezes-Ferreira MFlory ERenner MFerry NMarketing Regulatory Oversight  of Advanced Therapy Medicinal Products (ATMPs) in Europe: The EMA/CAT PerspectiveAdv Exp Med Biol. 2015;871:103-30

Samardzic J.Turner M.A.Bax R.Allegaert K.Neonatal Medicines Research: Challenges and OpportunitiesExpert Opin Drug Metab Toxicol. 2015 Jul;11(7):1041-52

Segec A.Keller-Stanislawski B.Vermeer N.S.Macchiarulo C.Straus S.M.Hidalgo-Simon A.De Bruin M.L.Strategy in Regulatory Decision-Making for Management of Progressive Multifocal LeukoencephalopathyClinical Pharmacology & TherapeuticsVol. 98(5)pp. 502-505.

Torneke K.Torren-Edo J.Grave K.Mackay D. K.The management of risk arising from the use of antimicrobials in veterinary medicine in EU/EEA countries – a reviewJ Vet Pharmacol Ther. doi: 10.1111/jvp.12226.

Torren E. J.Grave K.Mackay D.'“One Health”: the regulation and consumption of antimicrobials for animal use in the EU'IAHJVol. 2pp.14-16.

Tzogani KSkibeli VWestgaard IDalhus MThoresen HSlot KBDamkier PHofland KBorregaard JErsbøll JSalmonson TPieters RSylvester RMickisch GBergh JPignatti FThe European Medicines Agency approval of axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine: summary of the scientific assessment of the committee for medicinal products for human useOncologist. 2015 Feb;20(2):196-201

Vermeer N.S.Straus S.M.J.M.Mantel-Teeuwisse A.K.Hidalgo-Simon A.Egberts A.C.G.Leufkens H.G.M.De Bruin M.L.Drug-induced progressive multifocal leukoencephalopathy: Lessons learned from contrasting natalizumab and rituximabClinical Pharmacology and TherapeuticsVol. 98(5)pp. 542-550.

Walton M. K.Powers J. H. 3rdHobart J.Patrick D.Marquis P.Vamvakas S.Isaac M.Molsen E.Cano S.Burke L. B.Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task ForceValue Health Vol18pp. 741-52.

Aartsma-Rus A.Ferlini A.Goemans N.Pasmooij A. M.Wells D. J.Bushby K.Vroom E.Balabanov P.'Translational and regulatory challenges for exon skipping therapies'Human Gene TherapyVol. 25(10)pp. 885-92.

Abbing-Karahagopian V.Huerta C.Souverein P. C.de Abajo F.Leufkens H. G.Slattery J.Alvarez Y.Miret M.Gil M.Oliva B.Hesse U.Requena G.de Vries F.Rottenkolber M.Schmiedl S.Reynolds R.Schlienger R. G.de Groot M. C.Klungel O. H.van Staa T. P.van Dijk L.Egberts A. C.Gardarsdottir H.De Bruin M. L.'Antidepressant prescribing in five European countries: application of common definitions to assess the prevalenceclinical observationsand methodological implications'Eur J Clin PharmacolVol. 70(7)pp. 849-857.

Abbing-Karahagopian V.Kurz X.de Vries F.van Staa T. P.Alvarez Y.Hesse U.Hasford J.van Dijk L.de Abajo F. J.Weil J. G.Grimaldi-Bensouda L.Egberts A. C.Reynolds R. F.Klungel O. H.'Bridging differences in outcomes of pharmacoepidemiological studies: Design and first results of the Protect project'Curr Clin PharmacolVol 9pp. 130-138.

Abed IThe approval process of medicines in EuropeMedical writing (2014)Vol. 23No 2; p117 – 121

Abou-El-Enein MBauer GReinke PRenner MSchneider CKA roadmap toward clinical translation of genetically-modified stem cells for treatment of HIVTrends Mol Med. 2014 Nov;20(11):632-42.

Arlett P.Portier G.de Lisa R.Blake K.Wathion N.Dogne J. M.Spooner A.Raine J.Rasi G.'Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee'Nat Rev Drug DiscovVol. 13(5)pp. 395-397.

Arlett .PPostigo R.Janssen H.Spooner A.'Periodic Benefit-Risk Evaluation Report: A European Union Regulatory Perspective'. Pharmaceutical Medicine'Vol. 28(6)pp. 309-315.

Arlett P.Sarac S. B.Thomson A.Davies C.Teixeira T.Blake K. V.Stenver D.'The European Medicines Agency's use of prioritised independent research for best evidence in regulatory action on diclofenac'Pharmacoepidemiol Drug SafVol. 23(4)pp. 431-434.

Baird L. G.Banken R.Eichler H. G.Kristensen F. B.Lee D. K.Lim J. C.Lim R.Longson C.Pezalla E.Salmonson T.Samaha D.Tunis S.Woodcock J.Hirsch G.'Accelerated access to innovative medicines for patients in need'Clin Pharmacol TherVol. 96(5)pp. 559–571.

Balabanov P.Haas M.Elferink A.Bakchine S.Broich K.'Addressing the regulatory and scientific challenges in multiple sclerosis - a statement from the EU regulators'Mult SclerVol. 20(10)pp. 1282-1287.

Beckmann J.Hagemann U.Bahri P.Bate A.Boyd I. W.Dal Pan G. J.Edwards B. D.Edwards I. R.Hartigan-Go K.Lindquist M.McEwen J.Moride Y.Olsson S.Pal S. N.Soulaymani-Bencheikh R.Tuccori M.Vaca C. P.Wong I. C. K.'Teaching pharmacovigilance: the WHO-ISoP core elements of a comprehensive modular curriculum'Drug SafVol. 37(10)pp. 743-759.

Berntgen M.Gourvil A.Pavlovic M.Goettsch W.Eichler H.-G.Kristensen F. B.'Improving the contribution of regulatory assessment reports to health technology assessments - a collaboration between the European Medicines Agency and the European Network for Health Technology Assessment'Value in HealthVol. 17(5)pp. 634-641.

Blake K. V.Zaccaria C.Domergue F.La Mache E.Saint-Raymond A.Hidalgo-Simon A.'Comparison between paediatric and adult suspected adverse drug reactions reported to the European Medicines Agency: implications for pharmacovigilance'Pediatric DrugsVol. 16(4)pp. 309-319.

Bonini S.Eichler H. G.Wathion N.Rasi G.'Transparency and the European Medicines Agency – sharing of clinical trial data'N Engl J MedVol. 371(26)pp. 2452-2455.

Borg J. J.Tomasi P.Pani L.Aislaitner G.Pirozynski M.Leufkens H.Melchiorri D.'Licensing of generic medicines: are there any challenges left? A pharmaceutical regulatory perspective'Sci PharmVol. 82pp. 847-856.

Borg JJLaslop APani LMaciulaitis RMelchiorri DReflections on Decisions Made on the Well-Established Use of Medicinal Products by EU Regulators and the ECJSci Pharm. 2014; 82: 655–663

Caneva L.Bonelli M.Papaluca-Amati M.Vidal J. M.'Critical review on the environmental risk assessment of medicinal products for human use in the centralised procedure'Regul Toxicol PharmacolVol. 68(3)pp. 312-316.

Cerreta F.Temple R.Asahina Y.Connaire C.'Regulatory activities to address the needs of older patients'J Nutr Health Agingdoi: 10.1007/s12603-014-0494-4.

Clini EMFregonese LA conceptual framework for reporting experience of physical activity in COPDEur Respir J. 2014 Nov;44(5):1110-2

Cortes-Blanco .APrieto-Yerro C.Martinez-Lazaro R.Zamora J.Jiménez-Huete A.Haberkamp M.Pohly J.Enzmann H.Zinserling J.Strassmann V.Broich K.. 'Florbetapir (18F) for brain amyloid positron emission tomography: Highlights on the European marketing approval'Alzheimers Dement.Vol. 10(5 Suppl)pp. S395-9.

de Groot M. C.Schuerch M.de Vries F.Hesse U.Oliva B.Gil M.Huerta C.Requena G.de Abajo F.Afonso A. S.Souverein P. C.Alvarez Y.Slattery J.Rottenkolber M.Schmiedl S.Van Dijk L.Schlienger R. G.Reynolds R.Klungel O. H.'Antiepileptic drug use in seven electronic health record databases in Europe: A methodologic comparison'EpilepsiaVol. 55(5)pp. 666-673.

Egan A. G.Blind E.Dunder K.de Graeff P. A.Hummer B. T.Bourcier T.Rosebraugh C.'Pancreatic safety of incretin-based drugs — FDA and EMA assessment'N Engl J MedVol. 370(9)pp. 794-797.

Egger G. F.Manent N.'Re: Non-publication and delayed publication of randomized trials on vaccines: survey'BMJ2014Vol. 348g3058.

Franco P.Porta N.Holliday J. D.Willett P.'The use of 2D fingerprint methods to support the assessment of structural similarity in orphan drug legislation'J CheminformVol. 6(1): 5.

Giezen TJSchneider CKSafety assessment of biosimilars in Europe: a regulatory perspectiveGaBI Journal 2014;4:180-3.    

Gravanis I.Vleminckx C.Jonsson B.Pignatti F.'The changing world of oncology dug development: the regulatory bodies' perspective'Chin Clin OncolVol. 3(2)p. 22.

Grave K.Mackay D.Muller A.Torren-Edo J.'European Surveillance of Veterinary Antimicrobial Consumption (ESVAC): Establishment of the project and key outputs'Regulatory RapporteurVol. 11(9)pp. 4-9.

Grave K.Torren-Edo J.Muller A.Greko C.Moulin G.Mackay D.ESVAC Group'Variations in the sales and sales patterns of veterinary antimicrobial agents in 25 European countries'J Antimicrob ChemotherVol. 69(8)pp. 2284-2291.

Hampson L. V.Herold R.Posch M.Saperia J.Whitehead A.'Bridging the gap: A review of dose-investigations in paediatric investigation plans'Br J Clin PharmacolVol. 78(4)pp. 898–907.

Hanaizi Z.Unkrig C.Enzmann H.Camarero J.Sancho-Lopez A.Salmonson T.Gisselbrecht C.Laane E.Pignatti F.'The European Medicines Agency review of bosutinib for the treatment of adult patients with chronic myelogenous leukaemia: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use'Oncologist.Vol.19(4)pp. 421-5.

Herold R.Saint-Raymond A.Norga K.'Too few medicines for children with cancer'JAMA Pediatr.Vol.168(6)p. 583.

Hill D. L.Schwarz A. J.Isaac M.Pani L.Vamvakas S.Hemmings R.Carrillo M. C.Yu P.Sun J.Beckett L.Boccardi M.Brewer J.Brumfield M.Cantillon M.Cole P. E.Fox N.Frisoni G. B.Jack C.Kelleher T.Luo F.Novak G.Maguire P.Meibach R.Patterson P.Bain L.Sampaio C.Raunig D.Soares H.Suhy J.Wang H.Wolz R.Stephenson D.'Coalition Against Major Diseases / European Medicines Agency biomarker qualification of hippocampal volume for enrichment of clinical trials in predementia stages of Alzheimer's disease'Alzheimers DementVol. 10(4)pp. 421-429.

Karres J, Pratt V, Guettier JM, Temeck J, Tamborlane WV, Dunger D, Bejnariu C, De Beaufort C, Tomasi PJoining forces: a call for greater collaboration to study new medicines in children and adolescents with type 2 diabetesDiabetes Care. 2014 Oct;37(10):2665-7

Kurki P.Bielsky M.C.; Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) of Committee for Medicinal Products for Human Use (CHMP)'Letter to the editor: ECCO position challenged by European drug regulators'J Crohns Colitis. 2014 Mar;8(3):258

Lincker H.Ziogas C.Carr M.Porta N.EichlerH. G.'Regulatory watch: Where do new medicines originate from in the EU?'Nat Rev Drug DiscovVol. 13(2)pp. 92-93.

Mackay D.Grave K.Muller A.Torren-Edo J.'Key success factors for surveys of antimicrobial sales and use in the European Union'in proceeding: 'Responsible and prudent use of antimicrobial agents for animals. International solidarity to fight against antimicrobial resistance'OIE Global ConferenceParisFrance13-15 March 2013pp. 28-31.

Maignen FHauben MHung EHolle LVDogne JMA conceptual approach to the masking effect of measures of disproportionalityPharmacoepidemiol Drug Saf. 2014 Feb;23(2):208-17

Mariz S.Tsigkos S.Fregonese L.Aarum S.Dehlink R.Llinares J.Sepodes B.'The orphan framework as a new opportunity: an expert opinion'Informa healthcareVol. 2(11 )pp. 1181-1186.

Mentzer D.Desfontaine E.Tomasi P. A.'The importance and challenge of pediatric trials of hemophilia drugs'Nat Med.doi:10.1038/nm.3546

Narayan GCossu GGalli MCFlory EOvelgonne HSalmikangas PSchneider CKTrouvin JHClinical Development of Gene Therapy Needs a Tailored Approach: A Regulatory Perspective from the European UnionHum Gene Ther Clin Dev. 2014 Mar;25(1):1-6

Nofziger C.Papaluca M.Terzic A.Waldman S.Paulmichl M.'Policies to aid the adoption of personalized medicine'Nat Rev Drug DiscovVol. 13(3)pp. 159-160.

Pacurariu A.C.Coloma P. M.van Haren A.Genov G.Sturkenboom M. C.Straus S. M.'A description of signals during the first 18 months of the EMA Pharmacovigilance Risk Assessment Committee'Drug Saf.Vol. 37(12)pp.1059-66.

Peschel W.'The use of community herbal monographs to facilitate registrations and authorisations of herbal medicinal products in the European Union 2004-2012'J Ethnopharmacoldoi: 10.1016/j.jep

Petricciani JSheets RGriffiths EKnezevic I. Written with contributions from EMA staff Trullas and expert Fauconnier. No co-authorsso not included in ARAdventitious agents in viral vaccines: Lessons learned from 4 case studiesBiologicals. 2014 Sep;42(5):223-36    

Pfleiderer M.Trouvin J. H.Brasseur D.Gränstrom M.Shivji R.Mura M.Cavaleri M.'Brief Report for Vaccine - Summary of knowledge gaps related to quality and efficacy of current influenza vaccines'Vaccine.Vol 32(35)pp. 4586-91.

Pignatti F.Ehmann F.Hemmings R.Jonsson B.Nuebling M.Papaluca-Amati M.Posch M.Rasi G.'Cancer drug development and the evolving regulatory framework for companion diagnostics in the European Union'Clin Cancer Res. Vol. 20(6)pp.1458-68.

Quijano Ruiz B.Desfontaine E.Arenas-López S.Wang S.'Pediatric formulation issues identified in paediatric investigation plans'Expert Rev Clin PharmacolVol. 7(1)pp. 25-30.

Requena G.Abbing-Karahagopian V.Huerta C.De Bruin M. L.Alvarez Y.Miret M.Hesse U.Gardarsdottir H.Souverein P. C.Slattery J.Schneider C.Rottenkolber M.Schmiedl S.Gil M.De Groot M. C.Bate A.Ruigómez A.García Rodríguez L. A.Johansson S.de Vries F.Montero D.Schlienger R.Reynolds R.Klungel O. H.de Abajo F. J.'Incidence rates and trends of hip/femur fractures in five European countries: comparison using e-healthcare records databases'Calcif Tissue IntVol. 94(6)pp. 580-589.

Sabaté MPacheco JFBallarín EFerrer PPetri HHasford JSchoonen MWRottenkolber MFortuny JLaporte JRIbáñez L1; PROTECT Work Package 2A compilation of research working groups on drug utilisation across EuropeBMC Res Notes. 2014 Mar 13;7:143. doi: 10.1186/1756-0500-7-143.

Selker H. P.Oye K. A.Eichler H. G.Stockbridge N. L.Mehta C. R.Kaitin K. I.McElwee N. E.Honig P. K.Erban J. K.D'Agostino R. B. 'A proposal for integrated efficacy-to-effectiveness (E2E) clinical trials'Clin Pharmacol TherVol. 95(2)pp. 147-153.

Shankar GArkin SCocea LDevanarayan VKirshner SKromminga AQuarmby VRichards SSchneider CKSubramanyam MSwanson SVerthelyi DYim S; American Association of Pharmaceutical Scientists, Assessment and Reporting of the Clinical Immunogenicity of Therapeutic Proteins and Peptides - Harmonized Terminology and Tactical RecommendationsAAPS J. 2014 Jul;16(4):658-73

Snyder PJKahle-Wrobleski KBrannan SMiller DSSchindler RJDeSanti SRyan JMMorrison GGrundman MChandler JCaselli RJIsaac MBain LCarrillo MCAssessing Cognition and Function in Alzheimer's Disease Clinical Trials: Do We Have the Right Tools?Alzheimers Dement. 2014 Nov;10(6):853-60 

Sun H.Vesely R.Nelson R. M.Taminiau J.Szitanyi P.Isaac M.Klein A.Uzu S.Griebel D.Mulberg A. E.International Inflammatory Bowel Disease Working Group'Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussionpart 2: data extrapolationtrial designand pharmacokinetics'J Pediatr Gastroenterol NutrVol. 58(6)pp. 684-688.

Sun H.Vesely R.Taminiau J.Szitanyi P.Papadopoulos E. J.Isaac M.Klein A.Uzu S.Griebel D.Mulberg A. E.International Inflammatory Bowel Disease Working Group'Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussionpart 1: efficacy endpoints and disease outcome assessments'J Pediatr Gastroenterol NutrVol. 58(6)pp. 679-683.

Tomasi PSuccess of European Commission's paediatric regulation is establishedBMJ. 2014 Oct 14;349

Toussi MLis YQizilbash NBlake KVEhrenstein VKurz XMoore NSinclair MEncepp-HTA Working Group Survey on Capacity To Conduct Research in Support Of Health Technology AssessmentValue Health. 2014 Nov;17(7):A440. doi: 10.1016/j.jval.2014.08.1151. Epub 2014 Oct 26.   

Tsiftsoglou ASTrouvin JHCalvo GRuiz SDemonstration of BiosimilarityExtrapolation of Indications and Other Challenges Related to Biosimilars in EuropeBioDrugs. 2014 Dec;28(6):479-86

Tsigkos S.Llinares J.Mariz S.Aarum S.Fregonese L.Dembowska-Baginska B.Elbers R.Evers P.Foltanova T.Lhoir A.Corrêa-Nunes A.O'Connor D.Voordouw A.Westermark K.Sepodes B.'Use of biomarkers in the context of orphan medicines designation in the European Union'Orphanet J Rare DisVol. 9(1)13.

Tsigkos S.Mariz S.Llinares J.Fregonese L.Aarum S.Naumann-Winter F.Westermark K.Sepodes B.'Establishing medical plausibility in the context of orphan medicines designation in the European Union'Orphanet Journal of Rare DiseasesVol. 9: 175.

Tzogani KNagercoil NHemmings RJSamir BGardette JDemolis PSalmonson TPignatti FThe European Medicines Agency approval of ingenol mebutate (Picato) for the cutaneous treatment of non hyperkeratoticnon hypertrophic actinic keratosis in adults: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use (CHMP)Eur J Dermatol. 2014 Jul-Aug;24(4)

The Expert Panel on Therapeutic Products for InfantsChildrenand Youth'Improving Medicines for Children in Canada'the Council of Canadian Academies.

van Aerts L. A.De Smet K.Reichmann G.Willem van der Laan J.Schneider C. K.'Biosimilars entering the clinic without animal studies: A paradigm shift in the European Union'MAbs 6(5)pp. 1155-1162.

van Riet-Nales D. A.Römkens E. G.Saint-Raymond A.Kozarewicz P.Schobben A. F.Egberts T. C.Rademaker C. M.'Oral medicines for children in the European paediatric investigation plans'PLoS One.Vol. 9(6)p. e98348

Vetter T.GFR Decline as an End Point for Clinical Trials in CKD: A View From EuropeAm J Kidney DisVol. 64(6)pp. 838-840.

Vermeer NSDuijnhoven RGStraus SMMantel-Teeuwisse AKArlett PREgberts ACLeufkens HGDe Bruin MLRisk management plans as tool for proactive pharmacovigilance: a cohort study of newly approved drugs in EuropeClin Pharmacol Ther. 2014 Dec;96(6):723-31. doi: 10.1038/clpt.2014.184. Epub 2014 Sep 15.

Baird L. G.Trusheim M. R.Eichler H. G.Berndt E. R.Hirsch G.'Comparison of stakeholder metrics for traditional and adaptive development and licensing approaches to drug development'Therapeutic Innovation & Regulatory ScienceVol. 47(4)pp. 474-483.

Barkholt L.Flory E.Jekerle V.Lucas-Samuel S.Ahnert P.Bisset L.Büscher D.Fibbe W.Foussat A.Kwa M.Lantz O.Mačiulaitis R.Palomäki T.Schneider C. K.Sensebé L.Tachdjian G.Tarte K.Tosca L.Salmikangas P.'Risk of tumorigenicity in mesenchymal stromal cell-based therapies - bridging scientific observations and regulatory viewpoints'CytotherapyVol. 15(7)pp. 753-759.

Berntgen M.Enzmann H.Schabel E.Prieto Yerro C.Gómez-Outes A.Salmonson T.Musaus J.'Linaclotide for treatment of irritable bowel syndrome - the view of European regulators'Dig Liver DisVol. 45(9)pp. 724–726.

Berrut G.Andrieu S.Araujo de Carvalho I.Baeyens J. P.Bergman H.Cassim B.Cerreta F.Cesari M.Cha H. B.Chen L. K.Cherubini A.Chou M. Y.Cruz-Jentoft A. J.De Decker L.Du P.Forette B.Forette F.Franco A.Guimaraes R.Guttierrez-Robledo L. M.Jauregui J.Khavinson V.Lee W. J.Peng L. N.Perret-Guillaume C.Petrovic M.Retornaz F.Rockwood K.Rodriguez-Manas L.Sieber C.Spatharakis G.Theou O.Topinkova E.Vellas B.Benetos A.'Promoting access to innovation for frail old persons. IAGG (International Association of Gerontology and Geriatrics)WHO (World Health Organization) and SFGG (Société Française de Gériatrie et de Gérontologie) Workshop - Athens January 20-212012 Tool (GFST)'J Nutr Health AgingVol. 17(8)pp. 688-693.

Beyer A. R.Fasolo B.Phillips L. D.de Graeff P. A.Hillege H. L.'Risk perception of prescription drugs: results of a survey among experts in the European regulatory network'Med Decis MakingVol. 33(4)pp. 579-592.

Blackburn SCFArlett PRBenefit Risk Management Plans?Pharmaceutical Medicine. 2013;27(1):5-8

BrassartL.Skarlatos A.Papaluca M.Camanas Saez L.Cerreta F.'Product information and older people: how to assist informed prescription and safe therapeutic use?'Regulatory RapporteurVol. 10(7/8).

Breckenridge A.Eichler H. G.'Towards a prevention model of health care'Nat Rev Drug DiscovVol. 2(8)pp. 563-564.

Butlen-Ducuing F.Guelfi J. D.'Méthodes d'étude chez l'homme'in: Les antidépresseursLavoisierJanuary 2013.

Callréus T.Schneider C. K.'The emergence of regulatory science in pharmaceutical medicine'Pharm MedVol. 27(6)pp. 345-351.

da Rocha Dias S.Salmonson T.van Zwieten-Boot B.Jonsson B.Marchetti S.Schellens J. H.Giuliani R.Pignatti F.'The European Medicines Agency review of vemurafenib (Zelboraf®) for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'Eur J CancerVol. 49(7)pp. 1654-1661.

Egger G. F.Herold R.Rodriguez A.Manent N.Sweeney F.Saint-Raymond A.'European Union Clinical Trials Register: on the way to more transparency of clinical trial data'Expert Rev Clin PharmacolVol. 6(5)pp. 457-459.

Ehmann F.Papaluca Amati M.Salmonson T.Posch M.Vamvakas S.Hemmings R.Eichler H. G.Schneider C. K.'Gatekeepers and enablers: how drug regulators respond to a challenging and changing environment by moving toward a proactive attitude'Clin Pharmacol TherVol. 93(5)pp. 425–432.

Ehmann F.Sakai-Kato K.Duncan R.Hernán Pérez de la Ossa D.Pita R.Vidal J. M.Kohli A.Tothfalusi L.Sanh A.Tinton S.Robert J. L.Silva Lima B.Papaluca Amati M.'Next-generation nanomedicines and nanosimilars: EU regulators' initiatives relating to the development and evaluation of nanomedicines'Nanomedicine (Lond)Vol. 8(5)pp. 849-856.

Eichler H. G.Bloechl-Daum B.Brasseur D.Breckenridge A.Leufkens H.Raine J.Salmonson T.Schneider C. K.Rasi G.'The risks of risk aversion in drug regulation'Nat Rev Drug DiscovVol. 12(12)pp. 907-916.

Eichler H. G.Pétavy F.Pignatti F.Rasi G. 'Access to patient-level trial data - a boon to drug developers'N Engl J MedVol. 369(17)pp. 1577-1579.

Elmgren L.Li X.Wilson C.Ball R.Wang J.Cichutek K.Pfleiderer M.Kato A.Cavaleri M.Southern J.Jivapaisarnpong T.Minor P.Griffiths E.Sohn Y.Wood D.'A global regulatory science agenda for vaccines'VaccineVol. 31 Suppl 2pp. B163-B175.

Franco P.'Orphan drugs: the regulatory environment'Drug Discov TodayVol. 18(3-4)pp. 163-172.

Gravanis I.'Geriatric oncology: European Union regulatory perspectives and initiatives'J Geriatr OncolVol. 4(2)pp. 202-204.

Gravanis I.Lopez A. S.Hemmings R. J.Jiménez J. C.Garcia-Carbonero R.Gallego I. G.Giménez E. V.O'Connor D.Giuliani R.Salmonson T.Pignatti F.'The European Medicines Agency review of abiraterone for the treatment of metastatic castration-resistant prostate cancer in adult men after docetaxel chemotherapy and in chemotherapy-naive disease: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'OncologistVol. 18(9)pp. 1032-1042.

Henshall C.Sansom L.Eichler H.-G.Lemgruber A.Longson C.O'Rourke B.Tunis S.'Understanding the role and evidence expectations of health technology assessment and coverage/payer bodies. What are they looking forand how and why does this differ from what regulators require?'Therapeutic Innovation & Regulatory Science28 November 2013.

Hilger A.Arras-Reiter C.Keller-Stanislawski B.Ljungberg B.Male C.Mentzer D.Seitz R.Silvester G.'Comment on: MannucciP. M. Evolution of the European guidelines for the clinical development of factor VIII products'HaemophiliaVol. 19(3)pp. 349-350.

Janssens E.'Pharmaceuticals: EU initiative to tackle medication errors – Proposals and challenges'Eur J Risk RegulationVol. 3/2013pp. 388-391.

Karres J.Tomasi P.'New medicines for type 2 diabetes in adolescents: many productsfew patients'Expert Rev Clin PharmacolVol. 6(3)pp. 227-229.

Köhne C. H.Bedenne L.Carrato A.Bouché O.Popov I.Gaspà L.Valladares M.Rougier P.Gog C.Reichardt P.Wils J.Pignatti F.Biertz F.'A randomised phase III intergroup trial comparing high-dose infusional 5-fluorouracil with or without folinic acid with standard bolus 5-fluorouracil/folinic acid in the adjuvant treatment of stage III colon cancer: the Pan-European Trial in Adjuvant Colon Cancer 2 study'Eur J CancerVol. 49(8)pp. 1868-1875.

Liberti L.McAuslane N.Patel P.Breckenridge A.Eichler H. G.Peterson R.'Regulatory review: How do agencies ensure the quality of decision making?'Clin Pharmacol TherVol. 94(3)pp. 305-308.

Lionetti G.Kimura Y.Schanberg L. E.Beukelman T.Wallace C. A.Ilowite N. T.Winsor J.Fox K.Natter M.Sundy J. S.Brodsky E.Curtis J. R.Del Gaizo V.Iyasu S.Jahreis A.Meeker-O'Connell A.Mittleman B. B.Murphy B. M.Peterson E. D.Raymond S. C.Setoguchi S.Siegel J. N.Sobel R. E.Solomon D.Southwood T. R.Vesely R.White P. H.Wulffraat N. M.Sandborg C. I.'Using registries to identify adverse events in rheumatic diseases'PediatricsVol. 132(5)e1384-e1394.

Maignen F.Hauben M.Hung E.Holle L. V.Dogne J. M.'A conceptual approach to the masking effect of measures of disproportionality'Pharmacoepidemiol Drug SafVol. 23(2)pp. 208-217.

Maignen F.Hauben M.Hung E.Van Holle L.Dogne J. M.'Assessing the extent and impact of the masking effect of disproportionality analyses on two spontaneous reporting systems databases'Pharmacoepidemiol Drug SafVol. 23(2)pp. 195-207.

Maliepaard M.Nofziger C.Papaluca M.Zineh I.Uyama Y.Prasad K.Grimstein C.Pacanowski M.Ehmann F.Dossena S.Paulmichl M.'Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective'Nat Rev Drug DiscovVol. 12(2)pp. 103-115.

Manolis E.Rohou S.Hemmings R.Salmonson T.Karlsson M.Milligan P. A.. 'The role of modeling and simulation in development and registration of medicinal products: Output from the EFPIA / EMA Modeling and Simulation Workshop'CPT Pharmacometrics Syst PharmacolVol. 2e31.

Marshall S. F.Hemmings R.Josephson F.Karlsson M. O.Posch M.Steimer J. L.'Modeling and simulation to optimize the design and analysis of confirmatory trialscharacterize risk-benefitand support label claims'CPT Pharmacometrics Syst PharmacolVol. 2e27.

Melchiorri D.Pani L.Gasparini P.Cossu G.Ancans J.Borg J. J.Drai C.Fiedor P.Flory E.Hudson I.Leufkens H. G.Müller-Berghaus J.Narayanan G.Neugebauer B.Pokrotnieks J.Robert J. L.Salmonson T.Schneider C. K.'Regulatory evaluation of Glybera in Europe - two committeesone mission'Nat Rev Drug DiscovVol. 12(9)p. 719.

Péan E.Flores B.Hudson I.Sjöberg J.Dunder K.Salmonson T.Gisselbrecht C.Laane E.Pignatti F.'The European Medicines Agency review of pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's B-cell lymphomas: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'OncologistVol. 18(5)pp. 625-633.

Phillips L. D.Fasolo B.Zafiropoulous N.Eichler H. G.Ehmann F.Jekerle V.Kramarz P.Nicoll A.Lönngren T.'Modelling the risk-benefit impact of H1N1 influenza vaccines'Eur J Public HealthVol. 23(4)pp. 674-678.

Posch MComment to: Group sequential tests for delayed responsesHampsonLisa V.and Christopher Jennison. "Group sequential tests for delayed responses (with discussion)." Journal of the Royal Statistical Society: Series B (Statistical Methodology) 75.1 (2013): 3-54.

Putzeist M.Mantel-Teeuwisse A. K.Llinares J.Gispen-De Wied C. C.Hoes A. W.Leufkens H. G.'EU marketing authorization review of orphan and non-orphan drugs does not differ'Drug Discov TodayVol. 18(19–20)pp. 1001–1006.

Ruperto N.Vesely R.Saint-Raymond A.Martini A.'Impact of the European paediatric legislation in paediatric rheumatology: pastpresent and future'Ann Rheum DisVol. 72(12)pp.1893-1896.

Saint Raymond ALlinares JOrphan medicines: a success with a challenging futureExpert Opinion on Orphan Drugs2013 1:3185-187

Schneider CK'The ethics of biosimilars'GaBI JVol. 2(1)pp. 6-7.

Schneider CKBiosimilars in rheumatology: the wind of changeAnn Rheum Dis. 2013 Mar;72(3):315-8

Slattery J.Alvarez Y.Hidalgo A.'Choosing thresholds for statistical signal detection with the proportional reporting ratio'Drug SafVol. 36(8)pp. 687-692.

Staab A.Rook E.Maliepaard M.Aarons L.Benson C.'Modeling and simulation in clinical pharmacology and dose finding'CPT Pharmacometrics Syst PharmacolVol. 2e29.

Stephenson D.Aviles E.Bain L. J.Brumfield M.Carrillo M.Comery T. A.Compton C.Corrigan B.Forrest Gordon M.Jack C. R.Katz R.Logovinsky V.Satlin A.Marek K.Nicholas T.Polhamus D.Angersbach B. S.Raghavan N.Romano G.Romero K.Shaw L.Woodcock J.Vradenburg G.Isaac M.'Coalition Against Major Diseases:
precompetitive collaborations and regulatory paths to accelerating drug development for neurodegenerative diseases'Therapeutic Innovation & Regulatory ScienceVol. 47(6)pp. 632-638.

Tomasi P.'Paediatric clinical trials: need for capacity building'J Clin StudVol. 5(3)pp. 10-16.

Tomasi P.Saint-Raymond A.'Scope of the PIP in the EU: easier accessibility to the paediatric rewards and simplification of administrative requirements'Scrip Regulatory AffairsJanuary 2013p. 5.

Tsiftsoglou ASRuiz SSchneider CKDevelopment and regulation of biosimilars: current status and future challengesBioDrugs. 2013 Jun;27(3):203-11

Tzogani K.Straube M.Hoppe U.Kiely P.O'Dea G.Enzmann H.Salmon P.Salmonson T.Pignatti F.'The European Medicines Agency approval of 5-aminolaevulinic acid (Ameluz) for the treatment of actinic keratosis of mild to moderate intensity on the face and scalp: Summary of the scientific assessment of the Committee for Medicinal Products for Human Use'J Dermatolog TreatVol. 25(5)pp. 371-374.

van Riet Nales D. A.Kozarewicz P.Wang S.Saint-Raymond A.Robert J. L.'Comments on the EMA draft guideline: final steps towards a harmonized view between regulators and industry'Int J PharmVol. 457(1)pp. 337-339.

Vaquer G.Rivière F.Mavris M.Bignami F.Llinares-Garcia J.Westermark K.Sepodes B.'Animal models for metabolicneuromuscular and ophthalmological rare diseases'Nat Rev Drug DiscovVol. 12(4)pp. 287-305.

Vermeer N. S.Straus S. M.Mantel-Teeuwisse A. K.Domergue F.Egberts T. C.Leufkens H. G.De Bruin M. L.'Traceability of biopharmaceuticals in spontaneous reporting systems: a cross-sectional study in the FDA Adverse Event Reporting System (FAERS) and EudraVigilance databases'Drug SafVol. 36(8)pp. 617-625.

Vestergaard H. T.D'Apote L.Schneider C. K.Herberts C.'The evolution of nonclinical regulatory science: advanced therapy medicinal products as a paradigm'Mol TherVol. 21(9)pp. 1644-1648.

Vidal J. M.'Non-clinical science and regulatory approach. An introduction'Toxicologische CommunicatieData en DocumentatieVol. 3pp. 14-15.

Visser S. A.Manolis E.Danhof M.Kerbusch T.'Modeling and simulation at the interface of nonclinical and early clinical drug development'CPT Pharmacometrics Syst PharmacolVol. 2e30.

Bahri P.Harrison-Woolrych M.'Focusing on risk communication about medicines: why now?'Drug SafVol. 35(11)pp. 971-975.

Bahri P.Harrison-Woolrych M.'How to improve communication for the safe use of medicines? Discussions on social marketing and patient-tailored approaches at the annual meetings of the WHO Programme for International Drug Monitoring'Drug SafVol. 35(12)pp. 1073-1079.

Blake K. V.Devries C. S.Arlett P.Kurz X.Fitt H.'Increasing scientific standardsindependence and transparency in post-authorisation studies: the role of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance'Pharmacoepidemiol Drug SafVol. 21(7)pp. 690-696.

Blake KVMoore NKurz XENCePPMaking available observational study protocols and results: the role of ENCePPCirculation: Cardiovascular Quality and Outcomes. Reply to: 2012;5:4 418-419

Butlen-Ducuing F.Haas M.Pani L.van Zwieten-Boot B.Broich K.'DSM-5 and clinical trials in psychiatry: challenges to come?'Nat Rev Drug DiscovVol. 11(8)pp. 583-584.

Calderon M. A.Gerth van Wijk R.Eichler I.Matricardi P. M.Varga E. M.Kopp M. V.Eng P.Niggemann B.Nieto A.Valovirta E.Eigenmann P. A.Pajno G.Bufe A.Halken S.Beyer K.Wahn U.European Academy of Allergy and Clinical Immunology'Perspectives on allergen-specific immunotherapy in childhood: an EAACI position statement'Pediatr Allergy ImmunolVol. 23(4)pp. 300-306.

Cerreta F.Eichler H. G.Rasi G.'Drug policy for an aging population — the European Medicines Agency's geriatric medicines strategy'N Engl J MedVol. 367(21)pp. 1972-1974.

Cesari M.Fielding R. A.Pahor M.Goodpaster B.Hellerstein M.van Kan G. A.Anker S. D.Rutkove S.Vrijbloed J. W.Isaac M.Rolland Y.M'rini C.Aubertin-Leheudre M.Cedarbaum J. M.Zamboni M.Sieber C. C.Laurent D.Evans W. J.Roubenoff R.Morley J. E.Vellas B.International Working Group on Sarcopenia'Biomarkers of sarcopenia in clinical trials-recommendations from the International Working Group on Sarcopenia'J Cachexia Sarcopenia MuscleVol. 3(3)pp. 181-190.

Eichler H. G.Abadie E.Baker M.Rasi G.'Fifty years after thalidomide; what role for drug regulators?'Br J Clin PharmacolVol. 74(5)pp. 731-733.

Eichler H. G.Abadie E.Breckenridge A.Leufkens H.Rasi G.'Open clinical trial data for all? A view from regulators'PLoS MedVol. 9(4)e1001202.

Eichler H. G.Oye K.Baird L. G.Abadie E.Brown J.Drum C. L.Ferguson J.Garner S.Honig P.Hukkelhoven M.Lim J. C.Lim R.Lumpkin M. M.Neil G.O'Rourke B.Pezalla E.Shoda D.Seyfert-Margolis V.Sigal E. V.Sobotka J.Tan D.Unger T. F.Hirsch G.'Adaptive licensing: taking the next step in the evolution of drug approval'Clin Pharmacol TherVol. 91(3)pp. 426-437.

Galli MCLong-term follow-up of cancer patients treated with gene therapy medicinal productsJ Gene Med. 2012 Jun;14(6):440-2

Gaydos B.Koch A.Miller F.Posch M.Vandemeulebroecke M.Wang S.-J.'Perspective on adaptive designs: 4 years European Medicines Agency reflection paper1 year draft US FDA guidance – where are we now?'Clin InvestVol. 2(3)pp. 235-240.

Gispen-de Wied C.Stoyanova V.Yu Y.Isaac M.Pani L.de Andres-Trelles F.'The placebo arm in clinical studies for treatment of psychiatric disorders: a regulatory dilemma'Eur NeuropsychopharmacolVol. 22(11)pp. 804-811.

Grave K.Greko C.Kvaale M. K.Torren-Edo J.Mackay D.Muller A.Moulin G.ESVAC Group'Sales of veterinary antibacterial agents in nine European countries during 2005-09: trends and patterns'J Antimicrob ChemotherVol. 67(12)pp. 3001-3008.

Grein K.'Responsibilities of regulatory agencies in the marketing of antimicrobials'Rev Sci TechVol. 31(1)pp. 289-298.

Hidalgo-Simon A.Arlett P.'Pharmacovigilance in Europe: direction of travel in a changing environment'Expert Rev Clin PharmacolVol. 5(5)pp. 485-488.

Isaac M.Pani L.Gispen-de Wied C.Koch A.'European licensing of maintenance treatment in schizophrenia'LancetVol. 380(9841)pp. 562-563.

Isai A.Durand J.Le Meur S.Hidalgo-Simon A.Kurz X.'Autoimmune disorders after immunisation with Influenza A/H1N1 vaccines with and without adjuvant: EudraVigilance data and literature review'VaccineVol. 30(49)pp. 7123-7129.

Klug B.Celis P.Carr M.Reinhardt J.'Regulatory structures for gene therapy medicinal products in the European Union'In: Freeman T. (ed.)Gene transfer vectors for clinical applicationUnited KingdomAcademic Presspp. 337-354.

Knöss WChinou IRegulation of medicinal plants for public health--European community monographs on herbal substancesPlanta Med. 2012 Aug;78(12):1311-6 

Lumpkin M. M.Eichler H. G.Breckenridge A.Hamburg M. A.Lönngren T.Woods K.'Advancing the science of medicines regulation: the role of the 21st-century medicines regulator'Clin Pharmacol TherVol. 92(4)pp. 486-493.

Maciulaitis R.D'Apote L.Buchanan A.Pioppo L.Schneider C. K.'Clinical development of advanced therapy medicinal products in Europe: evidence that regulators must be proactive'Mol Ther20(3)pp. 479-482.

Maxwell S.Eichler H. G.Bucsics A.Haefeli W. E.Gustafsson L. L.e-SPC Consortium'e-SPC - delivering drug information in the 21st century: developing new approaches to deliver drug information to prescribers'Br J Clin PharmacolVol. 73(1)pp. 12-15.

Mischak H.Ioannidis J. P.Argiles A.Attwood T. K.Bongcam-Rudloff E.Broenstrup M.Charonis A.Chrousos G. P.Delles C.Dominiczak A.Dylag T.Ehrich J.Egido J.Findeisen P.Jankowski J.Johnson R. W.Julien B. A.Lankisch T.Leung H. Y.Maahs D.Magni F.Manns M. P.Manolis E.Mayer G.Navis G.Novak J.Ortiz A.Persson F.Peter K.Riese H. H.Rossing P.Sattar N.Spasovski G.Thongboonkerd V.Vanholder R.Schanstra J. P.Vlahou A.'Implementation of proteomic biomarkers: making it work'Eur J Clin InvestVol. 42(9)pp. 1027-1036.

Mullier F.Rahier J. F.Maignen F.Cornet Y.Graux C.Chatelain C.Chatelain B.Dogne J. M.'A case of therapy-related myeloid neoplasm in a patient with Crohn's disease treated with azathioprine'Acta HaematolVol. 128(1)pp. 1-6.

Pean E.Demolis P.Moreau A.Hemmings R. J.O'Connor D.Brown D.Shepard T.Abadie E.Pignatti F.'The European Medicines Agency review of cabazitaxel (Jevtana®) for the treatment of hormone-refractory metastatic prostate cancer: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'OncologistVol. 17(4)pp. 543-549.

Pean E.Klaar S.Berglund E. G.Salmonson T.Borregaard J.Hofland K. F.Ersbøll J.Abadie E.Giuliani R.Pignatti F.'The European Medicines Agency review of eribulin for the treatment of patients with locally advanced or metastatic breast cancer: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'Clin Cancer ResVol. 18(17)pp. 4491-4497.

Pelkonen O.Abass K.Wiesner J.'Thujone and thujone-containing herbal medicinal and botanical products: toxicological assessment'Regul Toxicol PharmacolVol. 65(1)pp. 100-107.

Pignatti F.Flores B.Jonsson B.'Platelet response as the basis for approval in chronic immune (idiopathic) thrombocytopenic purpura (ITP): a regulatory perspective'Am J HematolVol. 87pp. 943-944.

Posch M.Proschan M. A.'Unplanned adaptations before breaking the blind'Stat MedVol. 31(30)pp. 4146-4153.

Prieto L.Spooner A.Hidalgo-Simon A.Rubino A.Kurz X.Arlett P.'Evaluation of the effectiveness of risk minimization measures'Pharmacoepidemiol Drug SafVol. 21(8)pp. 896-899.

Putzeist M.Mantel-Teeuwisse A. K.Aronsson B.Rowland M.Gispen-de Wied C. C.Vamvakas S.Hoes A. W.Leufkens H. G.Eichler H. G.'Factors influencing non-approval of new drugs in Europe'Nat Rev Drug DiscovVol. 11(12)pp. 903-904.

Quigley K.'Veterinary medicines: What is the MUMS / limited markets policy?'Regulatory RapporteurVol. 10(2).

Saint-Raymond A.Herold R.'Medicines for pediatric oncology: can we overcome the failure to deliver?'Expert Rev Clin PharmacolVol. 5(5)pp. 493-495.

Sala Soriano E.Eichler I.Helms P. J.'Joined-up thinking'European Pharmaceutical ContractorMarch 2012pp. 35-36.

Schneider C. K.Vleminckx C.Gravanis I.Ehmann F.Trouvin J. H.Weise M.Thirstrup S.'Setting the stage for biosimilar monoclonal antibodies'Nat BiotechnolVol. 30(12)pp. 1179-1185.

Stegemann S.Baeyens J.-P.Cerreta F.Chanied E.Löfgren A.Maio M.Schreier G.Thesing-Bleck E.'Adherence measurement systems and technology for medications in older patient populations'Eur Geriatr MedVol. 3(4)pp. 254-260.

Tomasi P.'Writing applications for paediatric investigation plans and waivers'Medical WritingVol. 21(2)pp. 104-107.

van Riet-Nales D. A.Wang S.Saint-Raymond A.Robert J. L.'The EMA quality guideline on the pharmaceutical development of medicines for paediatric use'Int J PharmVol. 435(2)pp. 132-134.

Veselý R.Haf Davies E.'Helping the medicine go down'Public Service Review: European Science & TechnologyVol. 14pp. 1-2.

Videnova K.Mackay D. K.'Availability of vaccines against major animal diseases in the European Union'Rev Sci TechVol. 31(3)pp. 971-978.

Vinhas de Souza M.Keller-Stanislawski B.Blake K.Hidalgo-Simon A.Arlett P.Dal Pan G.'Drug-induced PML: a global agenda for a global challenge'Clin Pharmacol TherVol. 91(4)pp. 747-750.

Westermark K.Llinares J.'Promoting the development of drugs against rare diseases: what more should be done?'Expert Rev Pharmacoecon Outcomes ResVol. 12(5)pp. 541-543.

Zafiropoulos N.Phillips L.Pignatti F.Luria X.'Evaluating benefit–risk: an Agency perspective'Regulatory RapporteurVol. 9(6)pp. 5-8.

Zehetmayer S.Posch M.'False discovery rate control in two-stage designs'BMC BioinformaticsVol. 1381.

Zomerdijk I. M.Sayed-Tabatabaei F. A.Trifirò G.Blackburn S. C.Sturkenboom M. C.Straus S. M.'Risk minimization activities of centrally authorized products in the EU: a descriptive study'Drug SafVol. 35(4)pp. 299-314.

Arlett P.R.Kurz X.'New approaches to strengthen pharmacovigilance'Drug Discov Today TechnolVol. 8(1)e15–e19.

Arnardottir A. H.Haaijer-Ruskamp F. M.Straus S. M.Eichler H. G.de Graeff P. A.Mol P. G.'Additional safety risk to exceptionally approved drugs in Europe?'Br J Clin PharmacolVol. 72(3)pp. 490-499.

Bahri P.Mol P. G.Théophile H.Edwards I. R.Hugman B. P.'Communication in drug safety: a report from an interactive debate held at the 10th annual meeting of the International Society of Pharmacovigilance (ISoP)2010'Drug SafVol. 34(10)pp. 881-882.

Blake K. V.Prilla S.Accadebled S.Guimier M.Biscaro M.Persson I.Arlett P.Blackburn S.Fitt H.'European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance'Pharmacoepidemiol Drug SafVol. 20(10)pp. 1021-1029.

Blake K. V.Smeraldi C.Kurz X.Arlett P.Blackburn S.Fitt H.'The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance: application to diabetes and vascular disease'British Journal of Diabetes & Vascular DiseaseVol. 11(6)pp. 304-307.

Büttel I. C.Chamberlain P.Chowers Y.Ehmann F.Greinacher A.Jefferis R.Kramer D.Kropshofer H.Lloyd P.Lubiniecki A.Krause R.Mire-Sluis A.Platts-Mills T.Ragheb J. A.Reipert B. M.Schellekens H.Seitz R.Stas P.Subramanyam M.Thorpe R.Trouvin J. H.Weise M.Windisch J.Schneider C. K.'Taking immunogenicity assessment of therapeutic proteins to the next level'BiologicalsVol. 39(2)pp. 100-109.

Carleer J.Karres J.'Juvenile animal studies and pediatric drug development: a European regulatory perspective'Birth Defects Res B Dev Reprod ToxicolVol. 92(4)pp. 254-260.

De Mattia F.Chapsal J. M.Descamps J.Halder M.Jarrett N.Kross I.Mortiaux F.Ponsar C.Redhead K.McKelvie J.Hendriksen C.'The consistency approach for quality control of vaccines - a strategy to improve quality control and implement 3Rs'BiologicalsVol. 39(1)pp. 59-65.

Ehmann F.Schneider C. K.'Biosimilar monoclonal antibodies: The implications'Hospital Pharmacy EuropeVol. 56May/June 2011.

Eichler H. G.Abadie E.Breckenridge A.Flamion B.Gustafsson L. L.Leufkens H.Rowland M.Schneider C. K.Bloechl-Daum B.'Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response'Nat Rev Drug DiscovVol. 10(7)pp. 495-506.

Eichler I.Soriano E. S.'Close collaboration between academiaindustry and drug regulators is required in the development of allergen products for specific immunotherapy in children'AllergyVol. 66(8)pp. 999-1004.

Freire-Moran L.Aronsson B.Manz C.Gyssens I. C.So A. D.Monnet D. L.Cars O.ECDC-EMA Working Group'Critical shortage of new antibiotics in development against multidrug-resistant bacteria - time to react is now'Drug Resist UpdatVol. 14(2)pp. 118-124.

Hanaizi Z.van Zwieten-Boot B.Calvo G.Lopez A. S.van Dartel M.Camarero J.Abadie E.Pignatti F.'The European Medicines Agency review of ipilimumab (Yervoy) for the treatment of advanced (unresectable or metastatic) melanoma in adults who have received prior therapy: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'Eur J CancerVol. 48pp. 237-242.

Hatzakis A.Wait S.Bruix J.Buti M.Carballo M.Cavaleri M.Colombo M.Delarocque-Astagneau E.Dusheiko G.Esmat G.Esteban R.Goldberg D.Gore C.Lok A. S.Manns M.Marcellin P.Papatheodoridis G.Peterle A.Prati D.Piorkowsky N.Rizzetto M.Roudot-Thoraval F.Soriano V.Thomas H. C.Thursz M.Valla D.van Damme P.Veldhuijzen I. K.Wedemeyer H.Wiessing L.Zanetti A. R.Janssen H. L.'The state of hepatitis B and C in Europe: report from the hepatitis B and C summit conference'J Viral HepatVol. 18 Suppl 1pp. 1-16.

Heininger U.Bachtiar N. S.Bahri P.Dana A.Dodoo A.Gidudu J.Santos E. M.'The concept of vaccination failure'VaccineVol. 30(7)pp. 1265-1268.

Isaac M.Vamvakas S.Abadie E.Jonsson B.Gispen C.Pani L.'Qualification opinion of novel methodologies in the predementia stage of Alzheimer's disease: cerebro-spinal-fluid related biomarkers for drugs affecting amyloid burden - regulatory considerations by European Medicines Agency focusing in improving benefit'Eur NeuropsychopharmacolVol. 21(11)pp. 781-788.

Karres J.Tomasi P.Saint-Raymond A.'The development of pharmacological treatment of obesity in children. A European regulatory perspective'Bundesgesundheitsblatt Gesundheitsforschung GesundheitsschutzVol. 54(5)pp. 570-576.

Korakianiti E.Rekkas D.'Statistical thinking and knowledge management for quality-driven design and manufacturing in pharmaceuticals'Pharm ResVol. 28(7)pp. 1465-1479.

Kurz X.Domergue F.Slattery J.Segec A.Szmigiel A.Hidalgo-Simon A.'Safety monitoring of influenza A/H1N1 pandemic vaccines in EudraVigilance'VaccineVol. 29(26)pp. 4378-4387.

Leufkens H. G.Eichler H. G.'Innovative methods in drug regulatory sciences'Drug Discov Today TechnolVol. 8(1)e1-e2.

Leufkens H. G.Schellekens H.Aronsson B.'Post-innovation innovation of medicinal products'Drug Discov Today TechnolVol. 8(1)e37-e41.

Manolis E.Herold R.'Pharmacometrics for regulatory decision making: status and perspective'Clin PharmacokinetVol. 50(10)pp. 625-626.

Manolis E.Osman T. E.Herold R.Koenig F.Tomasi P.Vamvakas S.Saint-Raymond A.'Role of modeling and simulation in pediatric investigation plans'Paediatr AnaesthVol. 21(3)pp. 214-221.

Manolis E.Vamvakas S.Isaac M.'New pathway for qualification of novel methodologies in the European Medicines Agency'Proteomics Clin ApplVol. 5(5-6)pp. 248-255.

Mariz S.Llinares J.Westermark K.'Orphan drugs. EU regulations'BMJVol. 342d136.

Matt P.van Zwieten-Boot B.Calvo Rojas G.Ter Hofstede H.Garcia-Carbonero R.Camarero J.Abadie E.Pignatti F'The European Medicines Agency review of tegafur / gimeracil / oteracil (Teysuno™) for the treatment of advanced gastric cancer when given in combination with cisplatin: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'OncologistVol. 16(10)pp. 1451-1457.

Müllner M.Eichler H.-G.'Current issues in drug regulation'In: M. Müllner (ed.)Clinical Pharmacology: Current Topics and Case StudiesSpringer Viennapp. 19-31.

Nieto M.Borregaard J.Ersbøll J.ten Bosch G. J.van Zwieten-Boot B.Abadie E.Schellens J. H.Pignatti F.'The European Medicines Agency review of pazopanib for the treatment of advanced renal cell carcinoma: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'Clin Cancer ResVol. 17(21)pp. 6608-6614.

Nieto M.Calvo G.Hudson I.Feldschreiber P.Brown D.Lee C. C.Lay G.Valeri A.Abadie E.Thomas A.Pignatti F.'The European Medicines Agency review of eltrombopag (Revolade) for the treatment of adult chronic immune (idiopathic) thrombocytopenic purpura: summary of the scientific assessment of the Committee for Medicinal Products for Human Use'HaematologicaVol. 96(9)e33-e40.

Olski T. M.Lampus S. F.Gherarducci G.Saint Raymond A.'Three years of paediatric regulation in the European Union'Eur J Clin PharmacolVol. 67(3)pp. 245-252.

Phillips L. D.Fasolo B.Zafiropoulos N.Beyer A.'Is quantitative benefit-risk modelling of drugs desirable or possible?' Drug Discov Today TechnolVol. 8(1)e3–e10.

Pignatti F.Gravanis I.Herold R.Vamvakas S.Jonsson B.Marty M.'The European Medicines Agency: an overview of its missionresponsibilitiesand recent initiatives in cancer drug regulation'Clin Cancer ResVol. 17(16)pp. 5220-5225.

Pignatti F.Hemmings R.Jonsson B.'Is it time to abandon complete blinded independent central radiological evaluation of progression in registration trials?'Eur J CancerVol. 47(12)pp. 1759-1762.

Pignatti F.Luria X.Abadie E.Eichler H. G.'Regulatorspayersand prescribers: can we fill the gaps?'Lancet OncolVol. 12(10)pp. 930-931.

Pirmohamed M.Friedmann P. S.Molokhia M.Loke Y. K.Smith C.Phillips E.La Grenade L.Carleton B.Papaluca-Amati M.Demoly P.Shear N. H.'Phenotype standardization for immune-mediated drug-induced skin injury'Clin Pharmacol TherVol. 89(6)pp. 896-901.

Putzeist M.Heemstra H. E.Llinares Garcia J.Mantel-Teeuwisse A. K.Gispen-De Wied C. C.Hoes A. W.Leufkens H. G.'Determinants for successful marketing authorisation of orphan medicinal products in the EU'Drug Discov TodayVol. 17(7-8)pp. 352-358.

Rahmner P. B.Eiermann B.Korkmaz S.Gustafsson L. L.Gruvén M.Maxwell S.Eichler H. G.Vég A.'Physicians' reported needs of drug information at point of care in Sweden'Br J Clin PharmacolVol. 73(1)pp. 115-125.

Raine J.Wise L.Blackburn S.Eichler H. G.Breckenridge A.'European perspective on risk management and drug safety'Clin Pharmacol TherVol. 89(5)pp. 650-654.

Rocchi F.Tomasi P.'The development of medicines for children'Pharmacol ResVol. 64(3)pp. 169-175.

Ruperto N.Eichler I.Herold R.Vassal G.Giaquinto C.Hjorth L.Valls-i-Soler A.Peters C.Helms P. J.Saint Raymond A.'A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA)'Arch Dis ChildVol. 97(3)pp. 185-188.

Salmikangas P.Celis P.'Current challenges in the development of novel cell-based medicinal products'Regulatory RapporteurVol. 8(7-8)pp. 4-7.

Silva Lima B.'EMA responds to criticism of reflection paper on non-clinical studies for generic nano-particle iron medicinal product applications'Scrip Regulatory Affairs12 August 2011.

Vamvakas S.Martinalbo J.Pita R.Isaac M.'On the edge of new technologies (advanced therapiesnanomedicines)'Drug Discov Today TechnolVol. 8(1)e21-e28.

Vleminckx C.Ehmann F.'Guidelines EMA pour le développement de médicaments biosimilaires'OncologieVol. 13(5)pp. 191-195.

Voltz-Girolt C.Celis P.Boucaumont M.D'Apote L.Pinheiro M. H.Papaluca-Amati M.'The advanced therapy classification procedure. Overview of experience gained so far'Bundesgesundheitsblatt Gesundheitsforschung GesundheitsschutzVol. 54(7)pp. 811-815.

Weise M.Bielsky M. C.De Smet K.Ehmann F.Ekman N.Narayanan G.Heim H. K.Heinonen E.Ho K.Thorpe R.Vleminckx C.Wadhwa M.Schneider C. K.'Biosimilars - Why terminology matters'Nat BiotechnolVol. 29(8)pp. 690-693.

Westermark K.Holm B. B.Söderholm M.Llinares-Garcia J.Rivière F.Aarum S.Butlen-Ducuing F.Tsigkos S.Wilk-Kachlicka A.N'Diamoi C.Borvendég J.Lyons D.Sepodes B.Bloechl-Daum B.Lhoir A.Todorova M.Kkolos I.Kubáčková K.Bosch-Traberg H.Tillmann V.Saano V.Héron E.Elbers R.Siouti M.Eggenhofer J.Salmon P.Clementi M.Krieviņš D.Matulevičiene A.Metz H.Vincenti A. C.Voordouw A.Dembowska-Bagińska B.Nunes A. C.Saleh F. M.Foltánová T.Možina M.Torrent i Farnell J.Beerman B.Mariz S.Evers M. P.Greene L.Thorsteinsson S.Gramstad L.Mavris M.Bignami F.Lorence A.Belorgey C.'European regulation on orphan medicinal products: 10 years of experience and future perspectives'Nat Rev Drug DiscovVol. 10(5)pp. 341-349.

Wirth S.Kelly D.Sokal E.Socha P.Mieli-Vergani G.Dhawan A.Lacaille F.Saint-Raymond A.Olivier S.Taminiau J.'Guidance for clinical trials for children and adolescents with chronic hepatitis C'J Pediatr Gastroenterol NutrVol. 52(2)pp. 233-237.

Alvarez Y.Hidalgo A.Maignen F.Slattery J.'Validation of statistical signal detection procedures in EudraVigilance post-authorization data: a retrospective evaluation of the potential for earlier signalling'Drug SafVol. 33(6)pp. 475-487.

Bahri P.'Public pharmacovigilance communication: a process calling for evidence-basedobjective-driven strategies'Drug SafVol. 33(12)pp. 1065-1079.

Bauer P.Koenig F.Brannath W.Posch M.'Selection and bias - two hostile brothers'Stat MedVol. 29(1)pp. 1-13.

Blind E.Dunder K.de Graeff P. A.Abadie E.'Rosiglitazone: a European regulatory perspective'DiabetologiaVol. 54(2)pp. 213-218.

Bloechl-Daum B.Butlen-Ducuing F.Llinares-Garcia J.'Special situationsmarket fragmentation: orphan drugs for rare diseases' in: Clinical pharmacology: current topics and case studiesViennaNew YorkSpringer.

Brosch S.Spina A.'Pharmaceuticals: International Conference on Harmonisation and Standardisation initiatives in the pharmaceutical domain'Eur J Risk RegulationVol. 3pp. 274-276.

Butlen-Ducuing F.Rivière F.Aarum S.Llinares-Garcia J.'European Medicines Agency support mechanisms fostering orphan drug development'Drug News PerspectVol. 23(1)pp. 71-81.

Butlen-Ducuing F.Tsigkos S. 'Ten years of orphan drug designation in Europe'EHJP PracticeVol. 16(4)pp. 19-20.

Davies E. H.Ollivier C. M.Saint-Raymond A.'Paediatric investigation plans for pain: painfully slow!'Eur J Clin PharmacolVol. 66(11)pp. 1091-1097.

Del Seppia I.'Lost in translation': scientific names of medicine in a globalized world'Eur J Risk RegulationVol. 4pp. 431-435.

Dieterle F.Sistare F.Goodsaid F.Papaluca M.Ozer J. S.Webb C. P.Baer W.Senagore A.Schipper M. J.Vonderscher J.Sultana S.Gerhold D. L.Phillips J. A.Maurer G.Carl K.Laurie D.Harpur E.Sonee M.Ennulat D.Holder D.Andrews-Cleavenger D.Gu Y. Z.Thompson K. L.Goering P. L.Vidal J. M.Abadie E.Maciulaitis R.Jacobson-Kram D.Defelice A. F.Hausner E. A.Blank M.Thompson A.Harlow P.Throckmorton D.Xiao S.Xu N.Taylor W.Vamvakas S.Flamion B.Lima B. S.Kasper P.Pasanen M.Prasad K.Troth S.Bounous D.Robinson-Gravatt D.Betton G.Davis M. A.Akunda J.McDuffie J. E.Suter L.Obert L.Guffroy M.Pinches M.Jayadev S.Blomme E. A.Beushausen S. A.Barlow V. G.Collins N.Waring J.Honor D.Snook S.Lee J.Rossi P.Walker E.Mattes W.'Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium'Nat BiotechnolVol. 28(5)pp. 455–462.

Eichler H. G.Aronsson B.Abadie E.Salmonson T.'New drug approval success rate in Europe in 2009'Nat Rev Drug DiscovVol. 9(5)pp. 355-356.

Eichler H. G.Bloechl-Daum B.Abadie E.Barnett D.König F.Pearson S.'Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers'Nat Rev Drug DiscovVol. 9(4)pp. 277-291.

Eichler H. G.Hemmings R. J.Vamvakas S.'Where statisticians can contribute to address future challenges for drug regulatory agencies: a view from the European Medicines Agency (EMEA)'Stat Biopharm ResVol. 2(3)pp. 355-358.

Goodsaid F. M.Amur S.Aubrecht J.Burczynski M. E.Carl K.Catalano J.Charlab R.Close S.Cornu-Artis C.Essioux L.Fornace A. J. JrHinman L.Hong H.Hunt I.Jacobson-Kram D.Jawaid A.Laurie D.Lesko L.Li H. H.Lindpaintner K.Mayne J.Morrow P.Papaluca-Amati M.Robison T. W.Roth J.Schuppe-Koistinen I.Shi L.Spleiss O.Tong W.Truter S. L.Vonderscher J.Westelinck A.Zhang L.Zineh I.'Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact'Nat Rev Drug DiscovVol. 9(6)pp. 435-445.

Gravanis I.Ersbøll J.Skovlund E.Abadie E.Marty M.Pignatti F.'The European Medicines Agency review of ofatumumab (Arzerra®) for the treatment of chronic lymphocytic leukemia in patients refractory to fludarabine and alemtuzumab: summary of the scientific assessment of the European Medicines Agency Committee for Medicinal Products for Human Use'OncologistVol. 15(12)pp. 1335-1343.

Grave K.Torren Edo J.Mackay D.'Comparison of the sales of veterinary antibacterial agents between 10 European countries'J Antimicrob ChemotherVol. 65(9)pp. 2037-2040.

Herold R.Saint-Raymond A.'Preamble may not improve consent and assent process'Ped Blood CancerVol. 56(2)p. 327.

Isaac M.Koch A.'The risk of death among adult participants in trials of antipsychotic drugs in schizophrenia'Eur NeuropsychopharmacolVol. 20(3)pp. 139-145.

Jablonski T.'Pharmaceuticals: End of the transitional period for traditional herbal medicinal products coming soon'Eur J Risk RegulationVol. 2pp. 156-159.

Liberti L.Breckenridge A.Eichler H. G.Peterson R.McAuslane N.Walker S.'Expediting patients' access to medicines by improving the predictability of drug development and the regulatory approval process'Clin Pharmacol TherVol. 87(1)27-31.

Mackay D.Kriz N.'Current challenges in viral safety and extraneous agent testing'BiologicalsVol. 38(3)pp. 335-337.

Maignen F.Hauben M.Tsintis P.'Modelling the time to onset of adverse reactions with parametric survival distributions: a potential approach to signal detection and evaluation'Drug SafVol. 33(5)pp. 417-434.

Matheis K.Laurie D.Andriamandroso C.Arber N.Badimon L.Benain X.Bendjama K.Clavier I.Colman P.Firat H.Goepfert J.Hall S.Joos T.Kraus S.Kretschmer A.Merz M.Padro T.Planatscher H.Rossi A.Schneiderhan-Marra N.Schuppe-Koistinen I.Thomann P.Vidal J. M.Molac B.'A generic operational strategy to qualify translational safety biomarkers'Drug Discov TodayVol. 16(13-14)pp. 600-608.

Regnstrom J.Koenig F.Aronsson B.Reimer T.Svendsen K.Tsigkos S.Flamion B.Eichler H. G.Vamvakas S.'Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency'Eur J Clin PharmacolVol. 66(1)pp. 39-48.

Saint-Raymond A.'EMEA sees benefits for children'Applied Clinical Trials OnlineFebruary 2010.

Saint-Raymond A.'Regulatory aspects of drug development in children: change and resistance to change'Expert Rev Clin PharmacolVol. 3(5)pp. 593-595.

Saint-Raymond A.Hill S.Martines J.Bahl R.Fontaine O.Bero L.'CONSORT 2010'LancetVol. 376(9737)pp. 229-230.

Seigneuret N.'The paediatric regulation: three years on'Regulatory RapporteurVol. 7(6)pp. 5-9.

Silva-Lima B.Due Theilade-Thomsen M.Carleer J.Vidal J. M.Tomasi P.Saint-Raymond A.'Juvenile animal studies for the development of paediatric medicines: a description and conclusions from a European Medicines Agency workshop on juvenile animal testing for nonclinical assessors'Birth Defects Res B Dev Reprod ToxicolVol. 89(6)pp. 467-473.

Sistare F. D.Dieterle F.Troth S.Holder D.J.Gerhold D.Andrews-Cleavenger D.Baer W.Betton G.Bounous D.Carl K.Collins N.Goering P.Goodsaid F.Gu Y. Z.Guilpin V.Harpur E.Hassan A.Jacobson-Kram D.Kasper P.Laurie D.Lima B. S.Maciulaitis R.Mattes W.Maurer G.Obert L. A.Ozer J.Papaluca-Amati M.Phillips J. A.Pinches M.Schipper M. J.Thompson K. L.Vamvakas S.Vidal J. M.Vonderscher J.Walker E.Webb C.Yu Y.'Towards consensus practices to qualify safety biomarkers for use in early drug development'Nat BiotechnolVol. 28(5)pp. 446–454.

Spina A. 'European networks in the regulation of biotechnologies'Eur Law RevVol. 35(2)pp. 197-213.

Stoyanova-Beninska V. V.Wohlfarth T,. Isaac M.Kalverdijk L. J.van den Berg H.Gispen-de Wied C.'The EU paediatric regulation: effects on paediatric psychopharmacology in Europe'Eur NeuropsychopharmacolVol. 21(8)pp. 565-570.

Surh L. C.Pacanowski M. A.Haga S. B.Hobbs S.Lesko L. J.Gottlieb S.Papaluca-Amati M.Patterson S. D.Hughes A. R.Kim M. J.Close S. L.Mosteller M.Zineh I.Dechairo B.Cohen N. A.'Learning from product labels and label changes: how to build pharmacogenomics into drug-development programs'PharmacogenomicsVol. 11(12)pp. 1637-1647.

Tomasi P.'In search of safe and effective medicines'European Pharmaceutical Contractorwinter 2010pp. 46-49.

Vidal J. M.Kawabata T. T.Thorpe R.Silva-Lima B.Cederbrant K.Poole S.Mueller-Berghaus J.Pallardy M.van der Laan J. W.'In vitro cytokine release assays for predicting cytokine release syndrome: the current state-of-the-science. Report of a European Medicines Agency workshop'CytokineVol. 51(2)pp. 213-215.

Westermark KTsigkos SLlinares JIs it time to clarify orphan drug policies? Yesfor equity's sakeRapid Response to BMJ 2010;341:c4777

Borg J. J.Robert J. L.Wade G.Aislaitner D.Pirożynski M.Abadie E.Salmonson T.Vella Bonanno P.'Where is industry getting it wrong? A review of quality concerns raised at day 120 by the Committee for Medicinal Products for Human Use during European centralised marketing authorisation submissions for chemical entity medicinal products'J Pharm Pharm SciVol. 12(2)pp. 181-198.

Brasseur D.Pons G.Sain-Raymond A.'Le règlement européen de &quotmeilleurs médicaments pour les enfants en Europe&quot. Une chance pour la recherche et les soins en pédiatrie?' In: Delfosse M. L.Parizeau M. H.Amman J. P. La recherche clinique avec les enfants: à la croisée de l'éthique et du droit. BelgiumFranceQuebec: Editions Anthemispp. 51-66.

Broich K.'Committee for Medicinal Products for Human Use (CHMP) assessment on efficacy of antidepressants'Eur NeuropsychopharmacolVol. 19(5)pp. 305-308.

Celis P.Miglicacio G.Pedone E.Petracek J.Pinheiro M. H.Salmikangas P.Schneider C. K.'Advanced therapies: Regulatory principles and practice'Regulatory RapporteurVol. 6pp. 12-16.

Celis P.Pedone E.'The Committee for Advanced Therapies at the European Medicines Agency and the advanced therapies certification procedure'Drug DevelopmentVol. 4pp. 64-67.

Eichler H. G.Abadie E.Raine J. M.Salmonson T.'Safe drugs and the cost of good intentions'N Engl J MedVol. 360(14)pp. 1378-1380.

Eichler I.Saint-Raymond A.'The EU paediatric regulation: the way forward or a barrier to progress?'RAJ PharmaVol. 20pp. 347-348.

Fanciulli G.Tomasi P. A.Delitala A. P.Delitala G.'Activation of alpha1-adrenoceptors inhibits growth hormone secretion in humans'Exp Clin Endocrinol DiabetesVol. 117(9)pp. 460-462.

Giezen T. J.Mantel-Teeuwisse A. K.Strauss S. M. J. M.Egberts T. C. G.Blackburn S.Persson I.Leufkens H. G. M.'Evaluation of post-authorization safety studies in the first cohort of EU risk management plans at time of regulatory approval'Drug SafVol. 32(12)pp. 1175-1187.

Goedecke T.Brosch S.Arlett P.'EudraVigilance - the common EU database to support pharmacovigilance activities'Regulatory RapporteurVol. 6(2)pp. 6-11.

Grein K.'Pharmacovigilance and the European Medicines Agency: conduct of pharmacovigilance activities'In: WoodwardK. N. (ed.) Veterinary pharmacovigilance: adverse reactions to veterinary medicinal products. Wiley-Blackwell.

Jekerle V.Schröder C.Pedone E.'Legal basis of the advanced therapies regulation'Bundesgesundheitsblatt Gesundheitsforschung GesundheitsschutzVol. 53(1)pp. 4-8.

Ludolph A. C.Kassubek J.Landwehrmeyer B. G.Mandelkow E.Mandelkow E. M.Burn D. J.Caparros-Lefebvre D.Frey K. A.de Yebenes J. G.Gasser T.Heutink P.Höglinger G.Jamrozik Z.Jellinger K. A.Kazantsev A.Kretzschmar H.Lang A. E.Litvan I.Lucas J. J.McGeer P. L.Melquist S.Oertel W.Otto M.Paviour D.Reum T.Saint-Raymond A.Steele J. C.Tolnay M.Tumani H.van Swieten J. C.Vanier M. T.Vonsattel J. P.Wagner S.Wszolek Z. K.Reisensburg Working Group for Tauopathies With Parkinsonism'Tauopathies with parkinsonism: clinical spectrumneuropathologic basisbiological markersand treatment options'Eur J NeurolVol. 16(3)pp. 297-309.

Manolis E.Pons G.'Proposals for model-based paediatric medicinal development within the current European Union regulatory framework'Br J Clin PharmacolVol. 68(4)pp. 493–501.

Novelli G.Borgiani P.Ciccacci C.Di Daniele N.Sirugo G.Papaluca Amati M.'Pharmacogenomics: role in medicines approval and clinical use'Public Health GenomicsVol. 13(5)pp. 284-291.

Saint-Raymond A.'Médicaments pédiatriques et recherche : un équilibre fragile à trouver entre risques et bénéfices'In: Delfosse M. L.Parizeau M. H.Amman J.P. La recherche clinique avec les enfants: à la croisée de l'éthique et du droit. BelgiumFranceQuebec: Editions Anthemis.

Saint-Raymond A.Seigneuret N.'The European paediatric initiative: 1 year of experience'Paediatr DrugsVol. 11(1)pp. 9-10.

Saint-Raymond A.Sweeney F.'Clinical trials in developing countries: risk or opportunity?' Future Med ChemVol. 1(7)pp. 1193-1195.

Schneider C. K.Papaluca M.Kurki P.'A European perspective on immunogenicity evaluation'Nat BiotechnolVol. 27(6)pp. 507-508.

Scientific Advisory Group on Antimicrobials of the Committee for Medicinal Products for Veterinary Use'Reflection paper on the use of third and fourth generation cephalosporins in food producing animals in the European Union: development of resistance and impact on human and animal health'J Vet Pharmacol TherVol. 32(6)pp. 515-533.

Shah R. R.Saint Raymond A.'Regulation of human medicinal products in the European Union'In: Griffin J. P. The textbook of pharmaceutical medicine. 6th ed. London: BMJ Bookspp. 444-499.

Shivji R.Purves J.Celis P.'European Medicines Agency: influenza pandemic preparedness'. Risk Wise: EpidemicsISBN: 0-9536140-6-9pp. 36-39.

Tomasi PAFanciulli GCasti TDelitala GPersistent hyperprolactinemia and bilateral galactocele in a male infantInt J Pediatr Endocrinol. 2009; 2009: 578610

Blackburn S.'The European Network of Centres in Pharmacoepidemiology and Pharmacovigilance'PRM NewsletterVol. 0pp. 5-6.

Blind E.'Twenty years of progress with parathyroid hormone (PTH): from specialized and &quotdifficult&quot measurement to common laboratory parameter and treatment option in osteoporosis'Clin LabVol. 54pp. 439-449.

De Clercq K.Goris N.Barnett P. V.Mackay D. K.'FMD vaccines: reflections on quality aspects for applicability in European disease control policy'Transbound Emerg DisVol. 55(1)pp. 46-56.

De Clercq K.Goris N.Barnett P. V.Mackay D. K.'The importance of quality assurance/quality control of diagnostics to increase the confidence in global foot-and-mouth disease control'Transbound Emerg DisVol. 55(1)pp. 35-45.

Eichler H. G.Pignatti F.Flamion B.Leufkens H.Breckenridge A.'Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma'Nat Rev Drug DiscovVol. 7(10)pp. 818-826.

Hauben M.Vogel U.Maignen F.'Number needed to detect: nuances in the use of a simple and intuitive signal detection metric'Pharm MedVol. 22(1)pp. 13-22.

Llinares J.'Orphan designation in the EU: an overview and key achievements'Regulatory RapporteurNovember 2008pp. 5-9.

Neugebauer B.Drai C.Haase M.Hilger A.Keller-Stanislawski B.Laitinen-Parkkonen P.Mentzer D.Rasmussen C.Ratignier C.Seitz R.'Factor VIII products and inhibitor development: concepts for revision of European regulatory guidelines'HaemophiliaVol. 14(1)pp. 142-144.

Ormarsdottir S.Reginster J. Y.Abadie E.'European regulatory perspectives for innovative therapies'Osteoporos IntVol. 19(6)pp. 725-731.

Grein K.Papadopoulos O.Tollis M.'Safe use of vaccines and vaccine compliance with food safety requirements'Rev Sci TechVol. 26(2)pp. 339-350.

Mackay D.'Authorisation within the European Union of vaccines against antigenically variable viruses responsible for major epizootic diseases'Rev Sci TechVol. 26(2)pp. 421-428.