Patient Health Protection

The European Medicines Agency's Patient Health Protection Unit contributes to patient health protection through a proactive approach to pharmacovigilance and risk management throughout the lifecycle of centrally authorised human medicines.

The Unit:

• manages Community procedures aimed at reviewing the benefit and risk of centrally and nationally approved medicines;
• is responsible for crisis management of centrally authorised medicines;
• provides regulatory and procedural support to staff, scientific committees, working parties and experts participating in activities related to human medicines;
• provides the secretariats of the Committee for Medicinal Products for Human Use, the Committee on Herbal Medicinal Products, the Committee for Advanced Therapies and several working parties;
• is responsible for the quality review of product information, provision of information to patients and healthcare professionals, and fostering relations with representatives of civil society;
• coordinates the verification of compliance with good clinical, manufacturing and laboratory practices, and pharmacovigilance requirements;
• manages suspected quality defects and counterfeit medicines through the Agency’s coordinating role in the European Union (EU) regulatory system network;
• coordinates the sampling and testing of centrally authorised products;
• facilitates the implementation and operation of the clinical trials legal framework in the EU;
• operates the schemes for certificates of medicines and parallel distribution notifications.

Table of contents

• Head of Patient Health Protection
• Compliance and Inspection
• Medical Information
• Pharmacovigilance and Risk Management
• Regulatory, Procedural and Committee Support

Head of Patient Health Protection

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Head of Patient Health Protection

Noël Wathion

Nationality: Belgian

Career to date:

• Head of Patient Health Protection, European Medicines Agency (2009-present)
• Head of Post-Authorisation Evaluation of Medicines for Human Use, European Medicines Agency (2001-2009)
• Head of Regulatory Affairs and Pharmacovigilance, European Medicines Agency (1996-2001)
• Belgian Member of the Committee for Proprietary Medicinal Products and Committee for Medicinal Products for Veterinary Use, European Medicines Agency / Belgian representative on the Pharmaceutical Committee, Standing Committee and Notice to Applicants Working Group, European Commission, Brussels, Belgium (different time intervals, 1987-1996)
• Chief Inspector, acting as Secretary of the Belgian Medicines Commission, Ministry of Social Affairs, Public Health and Environment, Public Health Inspectorate, Brussels, Belgium (1987-1996)
• Pharmacist, Apotheek Bijnens Gerard, Genk, Belgium (1981-1987)

Education:

• Pharmacist, Free University Brussels, Belgium (1979)

Declaration of interests

Compliance and Inspection

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Head of Compliance and Inspection

Fergus Sweeney

Nationality: Irish

Career to date:

• Head of Compliance and Inspections, European Medicines Agency (2009-present)
• Scientific Administrator, European Medicines Agency  (1999-2009)
• Director of Quality Assurance, Covance, Brussels, Belgium (1991-1999)
• Manager of Quality Assurance, Institute of Clinical Pharmacology, Dublin, Ireland (1990)
• Deputy Manager and Director of Quality Assurance, Institute of Clinical Pharmacology, Dublin, Ireland (1986-1990)
• Laboratory Researcher, Institute of Clinical Pharmacology, Dublin, Ireland (1982-1986)

Education:

• Doctor of Philosophy in Pharmacology, University College Dublin, Ireland (1986)
• Doctorat de Troisième Cycle in endocrinology and development (cancer biology), University of Paris XI Orsay Centre, France (1982)
• Bachelor of Arts in natural sciences (physiology), Trinity College Dublin, Ireland (1979)

Declaration of interests

Head of Clinical and Non-clinical Compliance

Ana Rodriguez Sanchez Beato

Nationality: Spanish

Career to date:

• Head of Clinical and Non-clinical Compliance, European Medicines Agency (2009-present)
• Scientific Administrator, European Medicines Agency (2003-2009)
• Senior Clinical Research Associate, Covance, Madrid, Spain (2000-2003)
• Clinical Research Associate, Pfizer, Madrid, Spain (1997-2000)
• Post-doctoral Basic Researcher, Spanish National Research Council, Madrid, Spain (1995-1997)
• Pre-doctoral Basic Researcher, Spanish National Research Council, Madrid, Spain (1991-1995)

Education:

• Doctor of Philosophy in pharmacy,  Spanish National Research Council, Madrid, Spain (1995)
• Pharmacy degree, Complutense University, Madrid, Spain (1990)

Declaration of interests

Head of Manufacturing and Quality Compliance

David Cockburn

Nationality: British

Career to date:

• Head of Manufacturing and Quality Compliance, European Medicines Agency (2009-present)
• Principal Scientific Administrator, European Medicines Agency (2002-2009)
• Principal Medicines Inspector, Medicines Control Agency, York, United Kingdom (1996-2002)
• Medicines Inspector, Medicines Control Agency, York, United Kingdom (1987-1996)
• Section Head, Glaxo Operations, Ware, United Kingdom (1982-1987)
• Community Pharmacist, Oban, United Kingdom (1979-1982)
• Registration Officer, GD Searle, High Wycombe, United Kingdom (1978-1979)
• Pre-registration Pharmacy Graduate, Dunfermline, United Kingdom (1977-1978)

Education:

• Bachelor of Science with Honours in pharmacy, Robert Gordons Institute of Technology, Aberdeen, United Kingdom (1977)

Declaration of interests

Head of Parallel Distribution and Certificates

Francisco Peñaranda Fernández

Nationality: Spanish

Career to date:

• Head of Parallel Distribution and Certificates, European Medicines Agency (2009-present)
• Scientific Administrator, European Medicines Agency (1997-2009)
• Head of Analytical Research, Kao, Barcelona, Spain (1996-1997)
• Quality Assurance Specialist, Wassermann S.A., Barcelona, Spain (1987-1996)

Education:

• Post-graduate studies in quality management and statistics
• Degree in chemistry specialising in analytical chemistry, University of Barcelona, Spain

Declaration of interests

Medical Information

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Head of Medical Information

Isabelle Moulon

Nationality: French

Career to date:

• Head of Medical Information, European Medicines Agency (2005-present)
• Head of Safety and Efficacy of Medicines, European Medicines Agency (2001-2004)
• Deputy Head of Regulatory Affairs and Pharmacovigilance, European Medicines Agency (1998-2000)
• Responsible for the secretariat of the the Committee for Proprietary Medicinal Products, European Medicines Agency (1995-1998)
• Senior Medical Consultant in regulatory affairs for the pharmaceutical industry, Droit et Pharmacie, Paris, France (1993-1995)
• Deputy Head of Central Regulatory Affairs, ZYMA, Switzerland (1992-1993)
• Clinical Assessor, Ministry of Health, Paris, France (1987-1992)
• Endocrinologist and nutritionist in private practice, France (1985-1987)

Education:

• Post-graduate degree in clinical trial methodology, University of Paris, France (1990)
• Post-graduate degree in endocrine biochemistry, University of Lyon, France (1985)
• Specialisation in endocrinology and metabolic diseases, University of Lyon, France (1985)
• Post-graduate degree in nutrition and human dietetics, University of Nancy, France (1984)
• Qualified medical doctor, University of Grenoble, France (1984)

Declaration of interests 

Head of Product Information Quality

Alexios Skarlatos

Nationality: Greek

Career to date:

• Head of Product Information Quality, European Medicines Agency (2009-present)
• 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:

• Masters degree in European judicial studies, European Institute of Public Administration, Luxembourg (1994)
• Law degree, Democritean University of Thrace, Komotini, Greece (1993)

Declaration of interests

Head of Public Information and Stakeholder Networking

Juan Garcia Burgos

Nationality: Spanish

Career to date:

• Head of Public Information and Stakeholder Networking, European Medicines Agency (2009-present)
• Scientific Administrator, European Medicines Agency (2002-2009)
• Urologist, Gregorio Marañón University Hospital, Madrid, Spain (1997-2002)

Education:

• Specialisation in urology and urological surgery, Complutense University, Madrid, Spain (2002)
• Degree in medicine and surgery, Autonomous University of Madrid, Spain (1996)

Declaration of interests

Pharmacovigilance and Risk Management

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Head of Pharmacovigilance and Risk Management

Peter Arlett

Nationality: British

Career to date:

• Head of Pharmacovigilance and Risk Management, European Medicines Agency (2008-present)
• Principal Administrator, European Commission Pharmaceutical Unit, Brussels, Belgium (2003-2008).
• United Kingdom Delegate, Committee for Medicinal Products for Human Use, European Medicines Agency (2001-2003).
• Specialist Assessor and Manager, Medicines Control Agency, London, United Kingdom (1996-2001).
• Hospital Physician, National Health Service, London / Oxford, United Kingdom (1991-1996)

Education:

• Fellow of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, London, United Kingdom (2007)
• Member, Royal College of Physicians, London, United Kingdom (2004)
• Member of the Faculty of Pharmaceutical Medicine, Royal College of Physicians, London, United Kingdom (2002)
• Degree in medicine, University College London, United Kingdom (1991)

Declaration of interests

Head of Data Collection and Management

Paolo Alcini

Nationality: Italian

Career to date:

• Head of Data Collection and Management, European Medicines Agency (2009-present)
• EudraVigilance Scientific Administrator, European Medicines Agency (2005-2009)
• Scientific Administrative Assistant, European Medicines Agency (2004-2005)
• Information and Communications Technology System Administrator allocated to the EudraVigilance project at the European Medicines Agency, Bassilichi SpA, London, United Kingdom (2003-2004)
• System Administrator, AREA Science Park, Teorema Engineering, Trieste, Italy (2002)
• Lieutenant, Italian Army, Terni, Italy (2001-2002)
• Allievo Ufficiale di Complemento, Caserma Cecchignola, Rome, Italy (2001)
• Professor of Physics, Mathematics and Electronics, ITIS High School, Portogruaro, Italy (2000-2001)

Education:

• Masters degree in physics, University of Trieste, Italy (2000)

Declaration of interests

Head of Signal Detection and Data Analysis

Georgy Genov

Nationality: Bulgarian

Career to date:

• Head of Signal Detection and Data Analysis, European Medicines Agency (2012-present)
• Acting Head of Signal Detection and Data Analysis, European Medicines Agency (2011-2012)
• Scientific Administrator, European Medicines Agency (2010-2011)
• Associate Director Global Medical Affairs Immunology, UCB Pharma S.A., Brussels, Belgium (2006-2010)
• Project Manager, Cardiovascular, Johnson & Johnson Medical, Waterloo, Belgium (2002-2005)
• Medical Reviewer, Quintiles / Janssen Pharmaceutica N.V., Beerse, Belgium (2000-2002)
• Clinical Research Associate, Quintiles, Sofia, Bulgaria (1998-2000)
• Physician, Military Service, Bulgaria (1997-1998)

Education:

• Doctor of Medicine, Medical University, Sofia, Bulgaria (1996)

Declaration of interests

Head of Risk Management

Ana Hidalgo-Simon

Nationality: Spanish

Career to date:

• Head of Risk Management, European Medicines Agency (2012-present)
• Acting Head of Risk Management, 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:

• Diploma in heath economics, University of York, United Kingdom (2003)
• Doctor of Philosophy in clinical research, Royal Free Hospital School of Medicine, London, United Kingdom (1995)
• Doctor of Medicine and Surgery, University of the Basque Country, Bilbao, Spain (1990)

Declaration of interests

Head of Coordination and Networking

Henry Fitt

Nationality: British

Career to date:

• Head of Coordination and Networking, European Medicines Agency (2009-present)
• Member, European Network of Centres in Pharmacoepidemiology and Pharmacovigilance Steering Group, European Medicines Agency (2009-present) 
• Specialised Group Leader for Oncology, Blood, Cardiovascular and Diagnostic Products, European Medicines Agency (2006-2009)
• Product Team Leader, European Medicines Agency (2000-2006)
• Regulatory Affairs Executive, Nycomed Amersham, United Kingdom (1998-2000)
• Regulatory Affairs Executive, Almirall Prodesfarma, Barcelona, Spain (1993-1998)

Education:

• Certificate in Pharmacoepidemiology and Pharmacovigilance, London School of Hygiene and Tropical Medicine, United Kingdom (2001)
• Bachelor of Science with Honours in biochemistry, University of Bristol, United Kingdom (1988)

Declaration of interests

Regulatory, Procedural and Committee Support

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Head of Regulatory, Procedural and Committee Support

Anthony Humphreys

Nationality: Irish

Career to date:

• Head of Regulatory, Procedural and Committee Support, European Medicines Agency (2009-present)
• Head of Regulatory Affairs and Organisational Support, European Medicines Agency (2001-2009)
• Deputy Head of New Chemical Substances, European Medicines Agency (1998-2001)
• Senior Project Manager, European Medicines Agency (1996-1998)
• Senior Registration Officer, Glaxo Research and Development Limited, London, United Kingdom (1991-1996)
• Senior Project Pharmacist, Glaxo Research and Development Limited, London, United Kingdom (1988-1991)
• Development Pharmacist, Birex Pharmaceuticals Limited, Dublin, Ireland (1986-1988)
• Member, Pharmaceutical Society of Ireland (1984-present)

Education:

• Master in Science in pharmaceutics, Trinity College Dublin, Ireland (1986)
• Bachelor of Science in pharmacy, Trinity College Dublin, Ireland (1983)

Declaration of interests

Head of Regulatory Affairs

Zaïde Frias

Nationality: Belgian / Portuguese

Career to date:

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

• Certified industrial pharmacist, Belgisch Staatsblad (1996)
• Degree in business administration, Université Catholique de Louvain, Belgium (1994) 
• Masters degree in pharmaceutical sciences, Katholieke Universiteit Leuven, Belgium (1993)

Declaration of interests

Head of Community Procedures

Anabela Luis De Lima Marçal

Nationality: Portuguese

Career to date:

• Head of Community Procedures, European Medicines Agency (2009-present)
• Specialised Group Leader for Post-Authorisation Safety and Efficacy Central Nervous System / Endocrinology, European Medicines Agency (2001-2009)
• Scientific Administrator, European Medicines Agency (1999-2001)
• Scientific Administrator, Infarmed, Lisbon, Portugal (1995-1999)
• Hospital Pharmacist, Dona Estefânia Hospital, Lisbon, Portugal (1991-1995)
• Pharmacist, Community Pharmacy, Lisbon, Portugal (1991)

Education:

• Professional certification in hospital pharmacy, Portugal (1994)
• Degree in pharmacy, Portugal (1991)

Declaration of interests

Head of Scientific Committee Support

Sheila Kennedy

Nationality: Irish

Career to date:

• Head of Scientific Committee Support, European Medicines Agency (2009-present)
• Committee for Medicinal Products for Human Use Secretariat Administrator, European Medicines Agency (2002-2009)
• Acting Head of Inspections, European Medicines Agency (2001-2002)
• Inspections Administrator, European Medicines Agency (1996-2001)
• Assistant, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium (1992-1993)
• Quality Control Microbiologist, Convatec Ltd, Clwyd, United Kingdom (1989-1992)
• Quality Control Manager / Manager of Microbiological Services, Quest International, Wirral, United Kingdom (1988-1989)
• Plant Microbiologist, Rorer Ireland Ltd, Nenagh, Ireland (1986-1987)
• Section Head of Microbiology Research and Development, Stiefel Ireland Ltd, Sligo, Ireland (1984-1986)

Education:

• Postgraduate Diploma in industrial pharmaceutics, University of Brighton, United Kingdom (1992)
• Doctor of Philosophy in microbiology, Trinity College Dublin, Ireland (1986)
• Bachelor of Arts (Mod) Honours degree in natural sciences, Trinity College Dublin, Ireland (1980)

Declaration of interests