Human Medicines Evaluation

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The European Medicines Agency's Human Medicines Evaluation Division is responsible for activities related to the scientific, regulatory and procedural management of human medicines evaluation. 

This includes ensuring that the evaluation of submissions is performed in a timely manner and with the highest-possible quality.

An organisation chart shows the full structure of the Human Medicines Evaluation Division.

Table of contents


Head of Human Medicines Evaluation

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Head of Human Medicines Evaluation

Zaide FriasZaïde Frias

Nationality: Belgian / Portuguese

Career to date:

  • Head of Human Medicines Evaluation, European Medicines Agency (2016-present)
  • Head of Human Medicines Research and Development Support, European Medicines Agency (2015-2016)
  • Head of Human Medicines Research and Development Support (ad interim), European Medicines Agency (2013-2015)
  • Head of Regulatory Affairs and Best Evidence, European Medicines Agency (2013-present)
  • Head of Regulatory Affairs, European Medicines Agency (2009-2013)
  • Regulatory Affairs Adviser, European Medicines Agency (1999 -2009)
  • Regulatory Safety Officer, Pfizer SA, Brussels, Belgium (1996-1999)
  • Quality Control Supervisor, Pfizer SA, Brussels, Belgium (1995 -1996) 
  • Trainee, European Commission Directorate-General for Environment and Public Safety, Brussels, Belgium (1994-1995)
  • Community Pharmacist, Pharmacies Populaires de Bruxelles, Brussels, Belgium (1993)

Education:

Declaration of interests

Scientific and Regulatory Management

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Head of Scientific and Regulatory Management

Jordi LlinaresJordi Llinares Garcia

Nationality: Spanish

Career to date:

  • Head of Scientific and Regulatory Management, European Medicines Agency (2016-present)
  • Head of Product Development Scientific Support, European Medicines Agency (2013-2016)
  • Head of Orphan Medicines, European Medicines Agency (2009-2013)
  • Scientific Administrator, European Medicines Agency (2002-2009)
  • Member, Ethics Committee, Institut d'Assitencia Sanitaria, Girona-Salt, Spain (2000- 2002)
  • Lecturer in Clinical Pharmacology, Escola Universitaria d'Infermerria Sant Joan de Deu, Barcelona, Spain (1998-2002)
  • Clinical Pharmacologist, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (1998-2002)

Education:

Declaration of interests

Head of Anti-infectives and Vaccines

Marco CavaleriMarco Cavaleri

Nationality: Italian

Career to date:

  • Head of Anti-infectives and Vaccines, European Medicines Agency (2009-present)
  • Therapeutic Group Leader for Anti-infectives, European Medicines Agency (2008-2009)
  • Associate Scientific Director, Cosmo Pharmaceuticals S.p.A., Lainate, Italy (2008)
  • Scientific Administrator, European Medicines Agency (2005-2007)
  • Associate Director of Clinical Pharmacology, Tibotec BVBA, Mechelen, Belgium (2005)
  • Senior Clinical Scientist, Clinical Development, Vicuron Pharmaceuticals Italy srl, Gerenzano, Italy (2003-2005)
  • Preclinical Development Scientist and Head of Bioanalysis and Pharmacokinetics, Biosearch Italia, Gerenzano, Italy (1997-2003)

Education:

Declaration of interests

Head of Central Nervous System and Ophthalmology

Manuel HaasManuel Haas

Nationality: French

Career to date:

  • Head of Central Nervous System and Ophthalmology, European Medicines Agency (2009-present)
  • Scientific Administrator, European Medicines Agency (2003-2009)
  • Regulatory Affairs, Pfizer Global Research and Development, Sandwich, United Kingdom (2002-2003)
  • Hospital pharmacy, University Hospital of Tours / University Hospital of Poitiers, France (1999-2002)

Education:

Declaration of interests

Head of Endocrinology, Metabolism and Cardiovascular

Heidi JanssenHeidi Maria Janssen

Nationality: Belgian

Career to date:

  • Head of Endocrinology, Metabolism and Cardiovascular, European Medicines Agency (2011-present)
  • Scientific Administrator, European Medicines Agency (2002-2011)
  • European Clinical Pharmacology Coordinator, Lilly Clinical Development, Mont-Saint-Guibert, Belgium (2001-2002)
  • Clinical Trial Packaging Supervisor, Lilly Clinical Development, Mont-Saint-Guibert, Belgium (1999-2001)
  • Trainee, Eli Lilly, Fegersheim, France (1998-1999)

Education:

Declaration of interests

Head of Oncology, Haematology and Diagnostics

photo of PignattiFrancesco Pignatti

Nationality: Italian

Career to date:

  • Head of Oncology, Haematology and Diagnostics, European Medicines Agency (2009-present)
  • Head of Safety and Efficacy of Medicines (ad interim), European Medicines Agency (2012)
  • Scientific Administrator, European Medicines Agency (1999-2009)
  • Research Fellow / Medical Adviser, European Organisation for Research and Treatment of Cancer, Brussels, Belgium (1995-1999)

Education:

Declaration of interests

Head of Rheumatology, Respiratory, Gastroenterology and Immunology

Richard VeselýRichard Vesely

Nationality: Slovak

Career to date:

  • Head of Rheumatology, Respiratory, Gastroenterology and Immunology, European Medicines Agency (2014-present)
  • Scientific Officer, European Medicines Agency (2009-2014)
  • Clinical Head of Paediatric Department, Paediatrician, Paediatric Rheumatologist and Immunologist at Children's Faculty Hospital, Košice, Slovakia (2007-2008)
  • Consultant (locum), Paediatric Rheumatologist, The Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom (2006-2007)
  • Executive director, BDSR, spol. s r.o., Košice, Slovakia (1995-2003)
  • Senior Lecturer in Paediatrics and Medical Immunology,  Pavol Jozef Šafárik University,  Košice, Slovakia (1988-1993)
  • Paediatrician, Paediatric Rheumatologist and Immunologist, Children's Faculty Hospital, Košice, Slovakia (1981-2007)

Education:

  • Specialisation in Rheumatology, Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1996)
  • Specialisation in Medical Immunology Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1992)
  • Specialisation in Paediatrics 2nd grade Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1989)
  • Specialisation in Paediatrics 1st grade, Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1984)
  • Doctor of medicine, Pavol Jozef Šafárik University,  Košice, Slovakia (1981)

Declaration of interests

Head of Labelling Review and Standards Office

Alexios SkarlatosAlexios Skarlatos

Nationality: Greek

Career to date:

  • Head of Labelling Review and Standards Office, European Medicines Agency (2014-present)
  • Head of Product Information Quality, European Medicines Agency (2009-2014)
  • Responsible for the Quality Review of Documents Group Secretariat, European Medicines Agency (2004-2009)
  • Administrator, European Medicines Agency (2001-2004)
  • Translator, Translation Centre for the Bodies of the European Union, Luxembourg (1997-2001)
  • Research Assistant, Ministry of Interior and Public Administration, Athens, Greece (1994-1995)

Education:

Declaration of interests

Head of Regulatory Affairs

Sónia Ribeiro

Nationality: Portuguese

Career to date:

  • Head of Regulatory Affairs, European Medicines Agency (2014-present)
  • Regulatory Affairs Adviser, European Medicines Agency (2009-2014)
  • Scientific Administrator, European Medicines Agency (2005-2009)
  • National expert on Secondment, Scientific Administrator, European Medicines Agency (2004-2005)
  • Scientific Administrator, Infarmed, Lisbon, Portugal (2000-2004)

Education:

  • Post-graduation degree in Economic Evaluation of Medicines, Instituto Superior de Economia e Gestão e Faculdade de Farmácia da Universidade de Lisboa, Portugal (2002)
  • Degree in Pharmaceutical sciences, Faculdade de Farmácia da Universidade de Lisboa, Portugal (2000)

Declaration of interests

Procedure Management

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Head of Procedure Management

Evdokia KorakianitiEvdokia Korakianiti

Nationality: Greek

Career to date:

  • Head of Procedure Management, European Medicines Agency (2013-present)
  • Head of Chemicals, European Medicines Agency (2012-2013)
  • Scientific Administrator, European Medicines Agency (2002-2012)
  • New Products Development Manager, Famar SA (2000-2002)

Education:

Declaration of interests

Head of Evaluation Procedures A

Thomas CastelnovoThomas Castelnovo

Nationality: French

Career to date:

  • Head of Evaluation Procedures A, European Medicines Agency (2014-present)
  • Scientific Administrator, European Medicines Agency (2008-2014)
  • European Regulatory Affairs Manager, Merck Serono, Geneva, Switzerland (2005-2008)
  • European Regulatory Affairs Associate, Parexel, London, United Kingdom (2004-2005)
  • International Regulatory Affairs Executive, GlaxoSmithKline, London, United Kingdom (2003-2004)

Education:

Declaration of interests

Head of Evaluation Procedures B

Piotr KozarewiczPiotr Kozarewicz

Nationality: Polish

Career to date:

  • Head of Evaluation Procedures B, European Medicines Agency (2014-present)
  • Scientific Administrator, European Medicines Agency (2006-2014)
  • Medical Advisor, Novartis Poland Sp. z o. o. Consumer Health, Warsaw, Poland (2005-2006)
  • Regulatory Affairs Specialist, Schering-Plough Central East S. A., Warsaw, Poland (2003-2005)
  • Assessor / Quality Assurance Specialist / Specialist in Department of Basic and Applied Pharmacy, Office for Registration of Medical Products, Medical Devices and Biocidal Products, Warsaw, Poland (2000-2003)

Education:

Declaration of interests

Head of Evaluation Procedures C

Iordanis GravanisIordanis Gravanis

Nationality: Greek

Career to date:

  • Head of Evaluation Procedures C, European Medicines Agency (2014-present)

  • Scientific Administrator, European Medicines Agency (2008-2014)
  • Research Assistant, Stony Brook University, New York, United States (2002-2007)
  • Primary care physician, Ioannina, Greece (1998-2001)

Education:

Declaration of interests

Head of Evaluation Procedures D

Alberto Gañan JimenezAlberto Ganan

Nationality: Spanish

Career to date:

  • Head of Evaluation Procedures D, European Medicines Agency (2014-present)

  • Scientific Administrator, European Medicines Agency (2006-2014)
  • Business Intelligence Analyst, AstraZeneca, Madrid, Spain (2004-2006)
  • Public Health Inspector, Junta de Castilla y Leon, Soria, Spain (2003-2004)
  • Research fellow,Department of Molecular and Cell Biology, University of Zaragoza, Spain (1999-2003)

Education:

Declaration of interests

Head of Evaluation Procedures E

Irene RagerIrene_Rager

Nationality: German

Career to date:

  • Head of Evaluation Procedures E, European Medicines Agency (2014-present)
  • Regulatory Affairs Officer, European Medicines Agency (2010-2014)
  • Scientific Administrator, European Medicines Agency (2005-2010)
  • Group Leader of the Quality Control Unit for Finished Medicinal Products, Merck KGaA, Darmstadt, Germany (2005)
  • Head of Laboratory Quality Control for Finished Products, Merck KGaA, Darmstadt, Germany (2002-2005

Education:

Declaration of interests

Head of Evaluation Procedures F

Tânia TeixeiraTania Teixeira

Nationality: Portuguese

Career to date:

  • Head of Evaluation Procedures F, European Medicines Agency (2014-present)
  • Head of Referral Procedures (ad interim), European Medicines Agency (2013-2014)
  • Scientific Administrator, European Medicines Agency (2004-2013)  
  • Regulatory Affairs Manager, Decomed Farmacêutica, Massamá, Portugal (2001-2004)
  • Regulatory Affairs Officer, GlaxoSmithKline, Algés, Portugal (2001)
  • Regulatory Affairs Officer, SmithKline Beecham, Lisbon, Portugal  (2000-2001)

Education:

Declaration of interests

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