Human Medicines Evaluation

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The European Medicines Agency's Human Medicines Evaluation Division is responsible for the planning and reporting of the activities related to human-medicines evaluation, in particular ensuring that the evaluation of all submissions is performed in a timely manner, and with the highest-possible quality.

It manages the establishment of competencies in the therapeutic areas related to the medicinal products being evaluated, as well as those specialist scientific disciplines that are necessary to ensure a comprehensive assessment, to support and complement the competencies available in the network.

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

Enrica Alteri

Nationality: Italian

Career to date:

  • Head of Human Medicines Evaluation, European Medicines Agency (2013-present)
  • Head of Safety and Efficacy of Medicines, European Medicines Agency (2012-2013)
  • Head of Risk Management and Epidemiology, Merck-Serono, Geneva, Switzerland (2010-2011)
  • Head of Medical Safety Group, Neurodegenerative, Autoimmune and Inflammatory Diseases, Merck-Serono, Geneva, Switzerland (2007-2010)
  • Director of Clinical Safety and Pharmacovigilance, Serono, Geneva, Switzerland (2001-2007)
  • Manager of Drug Safety Post-marketing, Ares-Serono International, Geneva, Switzerland (1999-2001)
  • Manager of Scientific and Medical Communication, Ares-Serono International, Geneva, Switzerland (1998-1999)
  • Clinical Safety Expert, Novartis, Basel, Switzerland (1995-1998)
  • Clinical Safety Expert, Ciba, Basel, Switzerland (1993-1995)
  • Research Associate, Ciba-Geigy, Basel, Switzerland (1986-1993)
  • Visiting Fellow, National Institutes of Health, Bethesda, United States of America (1981-1984)

Education:

Declaration of interests

Scientific and Regulatory Management

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Head of Scientific and Regulatory Management

Michael BerntgenMichael Berntgen

Nationality: German

Career to date:

  • Head of Scientific and Regulatory Management, European Medicines Agency (2013-present)
  • Head of Rheumatology, Respiratory, Gastroenterology and Immunology, European Medicines Agency (2009-2013)
  • Scientific Administrator, European Medicines Agency (2007-2009)
  • Scientific Administrator, Federal Institute for Drugs and Medical Devices, Bonn, Germany (2006-2007)
  • Regulatory Project Manager, Roche Products Ltd., Welwyn Garden City, United Kingdom (2003-2006)
  • Drug Regulatory Affairs Manager, Hoffmann-La Roche AG, Grenzach-Wyhlen, Germany (1999-2003)
  • Drug Regulatory Affairs Manager, medac AG, Hamburg, Germany (1998-1999)
  • Scientific Assistant, Institute for Pharmaceutical Technology and Biopharmaceutics, Münster, Germany (1994-1997)

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 (ad interim)

Radhouane CherifRadhouane Cherif

Nationality: French

Career to date:

  • Head of Rheumatology, Respiratory, Gastroenterology and Immunology (ad interim), European Medicines Agency (2013-present)
  • Scientific Administrator, European Medicines Agency (2008-2013)
  • European Regulatory Affairs, Schering-Plough Europe, Brussels, Belgium (2000-2008)

Education:

Head of Risk Management Review (ad interim)

Corinne de VriesCorinne de Vries

Nationality: Dutch

Career to date:

  • Head of Risk Management review (ad interim), European Medicines Agency (2013-present)
  • Scientific Administrator, European Medicines Agency (2013)
  • Professor of Pharmacoepidemiology, University of Bath, United Kingdom (2008-2013)
  • Senior Lecturer and Reader, University of Surrey, Guildford, United Kingdom (1999-2007)
  • Research Fellow, University of Dundee, United Kingdom (1998-1999)
  • Research Fellow, University of Groningen, the Netherlands (1993-1997)

Education:

Specialised Scientific Disciplines

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Head of Specialised Scientific Disciplines

Ana Hidalgo-SimonAna Hidalgo-Simon

Nationality: Spanish

Career to date:

  • Head of Specialised Scientific Disciplines, European Medicines Agency (2013-present)
  • Head of Risk Management, European Medicines Agency (2012-2013)
  • Head of Risk Management (ad interim), European Medicines Agency (2011-2012)
  • Head of Signal Detection and Data Analysis, European Medicines Agency (2009-2011)
  • Scientific Administrator, European Medicines Agency (2003-2009)
  • Medical Editor, EuroTransmed, United Kingdom (1998-2003)
  • Scientific Project Manager, Medical Action Communications, United Kingdom (1997-1998)
  • International Clinical Trials Coordinator, SymbioClin, United Kingdom (1996-1997)
  • Post-doctoral Researcher, Clinical Research Centre, United Kingdom (1995-1996)

Education:

Declaration of interests

Head of Scientific Support

Marisa PapalucaMarisa Papaluca Amati

Nationality: Italian

Career to date:

  • Head of Scientific Support, European Medicines Agency (2013-present)
  • Head of Scientific Support and Projects, European Medicines Agency (2009-2013)
  • Deputy Head of Safety and Efficacy, European Medicines Agency (2002-2009)
  • Deputy Head of Biological Medicines, European Medicines Evaluation Agency (1998-2002)
  • Scientific Administrator, European Medicines Evaluation Agency (1995-1998)
  • Medical Director, Pharmaceutical Directorate of the Ministry of Health, Rome, Italy (1984-1994):
  • Practising physician and clinical immunology research fellow, Universitá Statale “La Sapienza”, Rome, Italy (1978-1985)

Education:

  • Diploma of Specialisation in internal medicine, Catholic University, Rome, Italy (1983)
  • Postgraduate Certificate in cardiology, Santo Spirito Hospital Medical School, Rome, Italy (1981)
  • Postgraduate Certificate in clinical endocrinology, Santo Spirito Hospital Medical School, Rome, Italy (1980)
  • Postgraduate Certificate in rheumatology, Santo Spirito Hospital Medical School, Rome, Italy (1979)
  • Degree in medicine and surgery, Universitá Statale “La Sapienza”, Rome, Italy (1978)

Declaration of interests

Head of Quality

Peter RichardsonPeter Richardson

Nationality: British

Career to date:

  • Head of Quality, European Medicines Agency (2013-present)
  • Head of Biologicals, European Medicines Agency (2009-2013)
  • Scientific Administrator, European Medicines Agency (2004-2009)
  • Pharmaceutical Assessor / Biologicals Working Party Member, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom (1998-2004)
  • Pharmaceutical industry employment, Bristol-Myers Squibb / Smithkline Beecham / Pfizer / Serono (1991-1998)

Education:

Declaration of interests

Head of Non-clinical Safety

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Head of Clinical Pharmacology

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Head of Biostatistics / Pharmaco-epidemiology

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