Human Medicines Research and Development Support

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The European Medicines Agency's Human Medicines Research and Development Support Division is in charge of providing scientific advice on all products and issues related to medicine development and proposing measures specifically aiming at fostering development of new medicines in orphan diseases and paediatric populations.

An organisation chart shows the full structure of the Human Medicines Research and Development Support Division.

Head of Human Medicines Research and Development Support

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Head of Human Medicines Research and Development Support

Enrica Alteri

Nationality: Italian

Career to date:

  • Head of Human Medicines Research and Development Support, European Medicines Agency (2016-present)
  • Head of Human Medicines Evaluation, European Medicines Agency (2013-2016)
  • 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

Product Development Scientific Support

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Head of Product Development Scientific Support

Michael BerntgenMichael Berntgen

Nationality: German

Career to date:

  • Head of Product Development Scientific Support, European Medicines Agency (2016-present)
  • Head of Scientific and Regulatory Management, European Medicines Agency (2013-2016)
  • 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

Deputy Head of Product Development Scientific Support

Spiridon Vamvakas

Spiros Vamvakas

Nationality: German / Greek

Career to date:

  • Deputy Head of Product Development Scientific Support, European Medicines Agency (2015-present)
  • Head of Scientific Advice, European Medicines Agency (2009-present)
  • Deputy Head of Scientific Advice and Orphan Drugs (ad interim), European Medicines Agency (2004-2009)
  • Principal Scientific Administrator, European Medicines Agency (1999-2004)
  • Associate Professor, University of Würzburg, Germany (1999-present)
  • Privat Dozent, University of Würzburg, Germany (1993-1999)
  • Lecturer, University of Würzburg, Germany (1990-1993)
  • Post-doctoral Fellow, University of Rochester Medical Center, United States (1988-1990)
  • Assistant, University of Würzburg, Germany (1984-1988)

Education:

  • Board-certified physician for pharmacology and toxicology, Bavarian Chamber of Physicians, Munich, Germany (1994)
  • Habilitation for pharmacology and toxicology, University of Würzburg, Germany (1993)
  • Medical degree, University of Würzburg, Germany (1984)

Declaration of interests

Head of Scientific Advice

Spiridon Vamvakas

Spiros Vamvakas

Nationality: German / Greek

Career to date:

  • Head of Scientific Advice, European Medicines Agency (2009-present)
  • Deputy Head of Product Development Scientific Support, European Medicines Agency (2015-present)
  • Deputy Head of Scientific Advice and Orphan Drugs (ad interim), European Medicines Agency (2004-2009)
  • Principal Scientific Administrator, European Medicines Agency (1999-2004)
  • Associate Professor, University of Würzburg, Germany (1999-present)
  • Privat Dozent, University of Würzburg, Germany (1993-1999)
  • Lecturer, University of Würzburg, Germany (1990-1993)
  • Post-doctoral Fellow, University of Rochester Medical Center, United States (1988-1990)
  • Assistant, University of Würzburg, Germany (1984-1988)

Education:

  • Board-certified physician for pharmacology and toxicology, Bavarian Chamber of Physicians, Munich, Germany (1994)
  • Habilitation for pharmacology and toxicology, University of Würzburg, Germany (1993)
  • Medical degree, University of Würzburg, Germany (1984)

Declaration of interests

Head of Paediatric Medicines

Paolo TomasiPaolo Tomasi

Nationality: Italian

Career to date:

Education:

Declaration of interests

Head of Orphan Medicines

Kristina LarssonKristina Larsson

Nationality: Swedish

Career to date:

  • Head of Orphan Medicines, European Medicines Agency (2014 – present)
  • Scientific Advice Administrator, European Medicines Agency (2006 – 2014)
  • Study Delivery Operations Specialist, AstraZeneca R&D Mölndal, Gothenburg, Sweden (2003-2006)
  • Trainee, Scientific Advice and Orphan Drugs, European Medicines Agency (2003)
  • Medical writer, Cell Therapeutics Scandinavia AB, Gothenburg, Sweden (2002 - 2003)

Education:

Declaration of interests

Head of Science and Innovation Support (ad interim)

Corinne de VriesCorinne de Vries

Nationality: Dutch

Career to date:

  • Head of Science and Innovation Support (ad interim), European Medicines Agency (2015-present)
  • Head of Risk Management review (ad interim), European Medicines Agency (2013-2014)
  • 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:

Declaration of interests

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 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 Biostatistics and Methodology Support

To be decided.

Head of Clinical Pharmacology and Non-clinical Support

To be decided.

Head of Working Parties Secretariat (ad interim)

Florence Deleska Florence_Deleska

Nationality:

Career to date:

  • Head of Working Parties Secretariat (ad interim), European Medicines Agency (2015-present)
  • Scientific Administrator, European Medicines Agency (2009-2015)
  • Regulatory Affairs Manager, Schering-Plough, Brussels, Belgium (2006-2009)
  • Regulatory Affairs Officer, Baxter, Brussels, Belgium (2003-2006)
  • Trainee, Baxter, Nivelles, Belgium (2003)
  • Deputy Head of Packaging, Schering AG, Lys-lez-Lannoy, France (2000-2003)
  • Deputy Head of Packaging, Laboratoires UPSA, Agen, France (1997-2000)
  • Project team manager, Laboratoires UPSA, Agen, France (1995-1997)
  • Trainee, Laboratoires UPSA, Agen, France (1994-1995)
  • Trainee, Roussel-Uclaf, Paris, France (1991-1992)
  • Hospital pharmacy trainee, Central University Hospitals, Nancy, France (1990-1991)

Education:

  • Masters in regulatory affairs and health economy, University of Lille/Paris/Lyon, France (2003)
  • Masters in pharmaceutical manufacturing, University of Bordeaux, France (1994)
  • Doctor of pharmacy specialising in industry, University of Nancy/Bordeaux, France (1996)

Declaration of interests

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