Human Medicines Development and Evaluation

The European Medicines Agency's Human Medicines Development and Evaluation Unit is responsible for the delivery of all activities relating to medicines for human use. These activities extend from the development stage right through the scientific advice and product life-cycle including special requirements for paediatric, orphan and advanced-therapy medicines.

The Unit:

• provides the secretariats of the Committee for Orphan Medicinal Products, Paediatric Committee and numerous working parties and scientific advisory groups of the Committee for Medicinal Products for Human Use;
• contributes to public health projects at European and international level;
• provides scientific support for activities related to emerging science;
• includes the Agency's Small and Medium-sized Enterprise Office providing support services covering both human and veterinary medicines.

Table of contents

• Head of Human Medicines Development and Evaluation
• Human Medicines Special Areas
• Safety and Efficacy of Medicines
• Quality of Medicines

Head of Human Medicines Development and Evaluation

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Head of Human Medicines Development and Evaluation

Patrick Le Courtois

Nationality: French

Career to date:

• Head of Human Medicines Development and Evaluation, European Medicines Agency (2009-present)
• Head of Pre-authorisation Evaluation of Medicines for Human Use, European Medicines Agency (2001-2009)
• Head of Scientific Advice and Orphan Drugs, European Medicines Agency (2001)
• Head of New Chemical Substances, European Medicines Agency (1998-2001)
• Human Medicinal Products Head of Unit Support, European Medicines Agency (1997-1998)
• French Delegate, Committee on Proprietary Medicinal Products, European Medicines Agency (1995-1997)
• Head of Oncology, Anti-infectives and Coordination of European Procedures, French Medicines Agency, Paris, France (1993-1997)
• Product Manager, Ministry of Health, Paris, France (1989 -1993)
• Internship in Public Health, University of Bordeaux, France (1986-1989)
• General Practitioner and Director of a medical centre, Paris, France (1977-1986)

Education:

• Specialist in Public Health, University of Bordeaux, France (1989)
• Qualified medical doctor, University of Paris, France (1978)
• Post-graduate degree in tropical medicine, University of Paris, France (1977)

Declaration of interests

Human Medicines Special Areas

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Head of Human Medicines Special Areas

Agnès Saint Raymond

Nationality: French

Career to date:

• Head of Human Medicines Special Areas, European Medicines Agency (2009-present)
• Acting Head of Safety and Efficacy, European Medicines Agency (2004-2005)
• Head of Scientific Advice and Orphan Drugs, European Medicines Agency (2001-2009)
• Head of Unit for Pharmaco-toxico-clinical Assessment, French Medicines Agency, France (1995-2000)
• Medical adviser, Laboratoires Roger Bellon and Servier International, France (1990-1995)
• Paediatrician, Necker Hospital for Sick Children, Paris (1981-1990)

Education:

• Post-graduate qualification in statistics and methodology, Paris (1988)
• Qualified in paediatrics, Paris (1987)
• Medical doctor, University of Paris, France (1986)

Declaration of interests

Head of Orphan Medicines

Jordi Llinares

Nationality: Spanish

Career to date:

• Head of Orphan Medicines, European Medicines Agency (2009-present)
• 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:

• Masters degree in science (epidemiology), London School of Hygiene and Tropical Medicine, United Kingdom (2009)
• Specialist in clinical pharmacology, Autonomous University of Barcelona, Spain (1997)
• Degree in medicine and surgery, University of Barcelona, Spain (1992)

Declaration of interests

Head of Paediatric Medicines

Paolo Tomasi

Nationality: Italian

Career to date:

• Head of Paediatric Medicines, European Medicines Agency (2009-present)
• Scientific Administrator, European Medicines Agency (2006-2009)
• Assistant Professor of Medicine, University of Sassari, Italy (2004-2006)
• Visiting Scientist, Whitehead Institute, Massachusetts Institute of Technology, Cambridge, United States (2002-2003)
• Assistant Professor of Medicine, University of Sassari, Italy (1999-2002)
• Attending Physician, Acute and Emergency Medicine, General Hospital, ASL Olbia, Italy (1990-1999)

Education:

• Clinical specialist in endocrinology, University of Genoa, Italy (1993)
• Doctor of Philosophy in endocrine and metabolic sciences, University of Florence, Italy (1990)
• Doctor of Medicine, University of Sassari, Italy (1984)

Declaration of interests

Head of Scientific Advice

Spiros Vamvakas

Nationality: German / Greek

Career to date:

• Head of Scientific Advice, European Medicines Agency (2009-present)
• Acting Deputy Head of Scientific Advice and Orphan Drugs, 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 Centre, 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 Support and Projects

Marisa Papaluca

Nationality: Italian

Career to date:

• Head of Scientific Support and Projects, European Medicines Agency (2009-present)
• 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):
  • Rapporteur / Expert, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (1991-1994)
  • Director, Operational Centre for Community Procedures (1991-1994)
  • Member, Committee for Proprietary Medicinal Products (1991-1994)
  • Member, Committee for Proprietary Medicinal Products Operations Working Party (1990-1993)
  • Member, Council for International Organizations of Medical Sciences Safety Working Group (1989-1994)
  • Member, Committee for Proprietary Medicinal Products Pharmacovigilance Working Party (1989-1994)
• 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 Small and Medium-sized Enterprise Office

Melanie Carr

Nationality: British

Career to date:

• Head of Small and Medium-sized Enterprise Office, European Medicines Agency (2009-present)
• Scientific Administrator, European Medicines Agency (1996-2009)
• Regulatory Affairs Executive, Roussel Uclaf, Romainville, France (1993-1996)
• Regulatory Affairs Assistant, Roussel Laboratories Limited, Denham, United Kingdom (1990-1993)
• Pre-registration Pharmacist, Abbott Laboratories, Queenborough, United Kingdom (1990)
• Pre-registration Pharmacist, St George's Hospital, London, United Kingdom (1989-1990)

Education:

• Bachelor of Pharmacy with Honours, University of Nottingham, United Kingdom (1989)

Declaration of interests

Safety and Efficacy of Medicines

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Head of Safety and Efficacy of Medicines

Enrica Alteri

Nationality: Italian

Career to date:

• Head of Safety and Efficacy of Medicines, European Medicines Agency (2012-present)
• 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:

• Certificate in Pharmaceutical Medicine, University of Basel, Switzerland / University of Strasbourg, France / University of Freiburg, Germany (1999)
• Doctor in Medicine and Surgery, La Sapienza University of Rome, Italy (1980)

Declaration of interests

Head of Anti-infectives and Vaccines

Marco 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:

• Upper degree in experimental pharmacology (1997)
• Degree in pharmaceutical sciences, University of Milan, Italy (1995)

Declaration of interests

Head of Central Nervous System and Ophthalmology

Manuel 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:

•  Post-graduate degree in hospital pharmacy / Doctor of Pharmacy, University of Poitiers, France (2003) 
•  Masters degree in international drug development and registration, University of Paris XI, France (2002) 
•  Qualified pharmacist, University of Poitiers, France (1999)

Declaration of interests

Head of Endocrinology, Metabolism and Cardiovascular

Heidi 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:

• Industrial Pharmacist (registered), Belgium (1999)
• Pharmacist (master), Free University Brussels, Belgium (1998)

Declaration of interests

Head of Oncology, Haematology and Diagnostics

Francesco Pignatti

Nationality: Italian

Career to date:

• Head of Oncology, Haematology and Diagnostics, European Medicines Agency (2009-present)
• Acting Head of Safety and Efficacy of Medicines, 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:

• Master of Science in biostatistics, Limburg University Centre, Belgium (1998)
• Medical doctor degree, Sapienza University of Rome, Italy (1995)

Declaration of interests

Head of Rheumatology, Respiratory, Gastroenterology and Immunology

Michael Berntgen

Nationality: German

Career to date:

• Head of Rheumatology, Respiratory, Gastroenterology and Immunology, European Medicines Agency (2009-present)
• 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:

• Master of Drug Regulatory Affairs, Rhenish Friedrich-Wilhelms-University, Bonn, Germany (2003)
• Doctor of Science in pharmaceuticals, Westphalian Wilhelm's University Münster, Germany (1997)
• Certification as pharmacist, Philipps University Marburg, Germany (1993)

Declaration of interests

Quality of Medicines

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Head of Quality of Medicines

Alexis Nolte

Nationality: French

Career to date:

• Head of Quality of Medicines, European Medicines Agency (2010-present)
• Acting Head of Product Data Management, European Medicines Agency (2009-2010)
• Scientific Administrator, Quality of Medicines - Biologicals, European Medicines Agency (2004-2009)
• Consultant to World Health Organization (2003-2004)
• Scientific Administrator, Quality of Medicines - Biologicals, European Medicines Agency (1999-2002)
• Post-doctoral Research Scientist, Pasteur Institute, Paris, France (1997-1998)
• Research Fellow, Freie Universität Berlin, Germany (1992-1996)
• Trainee, European Commission Directorate-General for Research / Biotechnology (1997)
• Research Fellow, INSERM U272 Research Unit, Nancy, France (1990-1992)
• Research Fellow, University of Denver, United States (1991-1992)
• Hospital Pharmacy Trainee, Central University Hospitals, Nancy, France (1990-1991)

Education:

• Diploma in strategic management and leadership, Chartered Management Institute, United Kingdom (2011)
• Masters in regulatory affairs and pharmaceutical legislation, University of Lille, France (1997)
• Doctor of Philosophy in biochemistry / molecular biology, Freie Universität Berlin, Germany (1996)
• Doctor of Pharmacy, University of Nancy, France (1992)
• Masters degree in biochemistry, University of Nancy, France (1990)

Declaration of interests

Head of Biologicals

Peter Richardson

Nationality: British

Career to date:

• Head of Biologicals, European Medicines Agency (2009-present)
• 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)
• Member, Royal Pharmaceutical Society, London, United Kingdom

Education:

• Doctor of Philosophy, Queens University of Belfast, United Kingdom (1990)
• Bachelor of Science in pharmacy, Queens University of Belfast, United Kingdom (1986)

Declaration of interests

Head of Chemicals

Evdokia Korakianiti

Nationality: Greek

Career to date:

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

Education:

• Doctor of Philosophy in pharmaceutical technology, University of Athens, Greece
• Master of Science in industrial pharmacy, University of Athens, Greece
• Pharmacy degree, University of Athens, Greece

Declaration of interests