Advisory functions and Deputy Executive Director support services

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The European Medicines Agency's advisory functions provide support and advice to the Executive Director, the Deputy Executive Director and the Agency on a range of operational, policy and scientific issues in their various fields of expertise.

The Senior Medical Officer advises the Executive Director on all scientific and public-health issues.

The Head of the Programme Design Board is in charge of the oversight and review of projects developed in the framework of the Agency’s reorganisation, with particular responsibility for improved quality, efficiency and effectiveness of the Agency’s procedures and processes.

There are also cross-Agency functions responsible for coordinating international activities and relations with international partners, the Agency’s internal audit capability and the Legal Department for provision of legal advice.

An organisation chart shows the full structure of the advisory functions.

Senior Medical Officer

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Senior Medical Officer

Hans-Georg Eichler

Nationality: Austrian

Career to date:

Education:

  • Master of Science in toxicology, University of Surrey, Guildford, United Kingdom (1980)
  • Doctor of medicine, University of Vienna Medical School, Austria (1979)

Declaration of interests

Programme Design Board

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Head of Programme Design Board

Agnes SaintRaymondAgnès Saint Raymond

Nationality: French

Career to date:

  • Head of Programme Design Board, European Medicines Agency (2013-present)
  • Head of Human Medicines Special Areas, European Medicines Agency (2009-2013)
  • Head of Safety and Efficacy (ad interim), 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:

Declaration of interests

International Affairs

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Head of International Affairs

Emer Cooke's portraitEmer Cooke

Nationality: Irish

Career to date:

  • Head of International Affairs, European Medicines Agency (2013-present)
  • Head of International and European Cooperation, European Medicines Agency (2012-2013)
  • Head of International and European Cooperation (ad interim), European Medicines Agency (2012)
  • International Liaison Officer, European Medicines Agency (2009-2012)
  • Head of Inspections, European Medicines Agency (2002-2008)
  • Principal Administrator, European Commission Pharmaceuticals Unit, Brussels, Belgium (1998-2002)
  • Manager, Scientific and Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium (part-time 1996-1998)
  • Independent Pharmaceutical Policy Advisor, Prague, Czech Republic (part-time 1996-1998)
  • Manager Scientific and Regulatory Affairs, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium (1992-1995)
  • Acting Regulatory Affairs Manager, Chanelle Pharmaceuticals Manufacturing Limited, Galway, Ireland (1991)
  • Pharmaceutical Assessor, National Drugs Advisory Board, Dublin, Ireland (1988-1990)
  • Pharmaceutical Development Manager, Intercon Pharma Limited, Dublin, Ireland (1987-1988)
  • Registration Pharmacist, Mary Purcell Limited, Dublin, Ireland (1986-1987)
  • Community Pharmacist, ODC Chemists Limited, Dublin, Ireland (1985-1986)

Education:

  • Masters degree in business administration, Trinity College Dublin, Ireland (1991)
  • Diploma in management and industrial relations, National College of Industrial Relations, Dublin, Ireland (1990)
  • Master of Science in pharmaceutical chemistry, Trinity College Dublin, Ireland (1985)
  • Bachelor of science in pharmacy, Trinity College Dublin, Ireland (1982)

Declaration of interests

Audit

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Head of Audit

Edit WeidlichEdit Weidlich

Nationality: Hungarian

Career to date:

  • Head of Audit, European Medicines Agency (2013-present)
  • Head of Internal Audit, European Medicines Agency (2009-2013)
  • Vice President, Government Audit Office, Budapest, Hungary (2007-2009)
  • Commissioner to the Minister of Finance, Budapest, Hungary (2003-2007)
  • Director General, Government Control Office, Budapest, Hungary (1993-2003)
  • Deputy Head of Unit, Ministry of Industry and Trade, Budapest, Hungary (1980-1993)

Education:

  • Certified Chartered accountant degree, Institute of Chartered Accountant, Hungary (2008)
  • Certified government auditing professional, Institute of Internal Auditors, Altamonte Springs, United States (2006)
  • Doctoral degree in international economics, University of Economics, Budapest, Hungary (1987)
  • Masters degree in mathematics and system analysis, Eötvös Loránd University, Budapest, Hungary (1977)

Declaration of interests

Legal

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Head of Legal

Stefano MarinoStefano Marino

Nationality: Italian

Career to date:

  • Head of Legal, European Medicines Agency (2013-present)
  • Head of Anti-fraud Office (ad interim), European Medicines Agency (2015-present)
  • Head of Legal Service, European Medicines Agency (2013)
  • Corporate Legal and Intellectual Property Director, Sigma-Tau, Rome, Italy (1997-2013)
  • Chairman, Corporate Governance Committee, Sigma-Tau Pharmaceuticals Inc., Gaithersburg, United States (2012-2013)
  • Board Member and Corporate Secretary, Sigma-Tau Pharmaceuticals Inc., Gaithersburg, United States (2001-2013)
  • Chief Compliance Officer, Sigma-Tau, Rome, Italy (2010-2013)
  • Chairman, Trademark Committee, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium (2005-2013)
  • Member, Intellectual Property Policy Committee, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium (1998-2011)
  • Intellectual Property Contract Manager, Montell, Milan, Italy (1996-1997)
  • General Counsel, A. Menarini, Florence, Italy (1988-1996)
  • Customs and Excise Officer, Bergamo / Florence, Italy (1986-1987)

Education:

  • Admission to the bar of Italian solicitors (1989)
  • Legal practitioner, Studio Legale M. Siniscalchi, Consenza, Italy (1986-1988)
  • Research fellowship in public law and economics, Italian Parliament, Rome, Italy (1988)
  • Research fellowship in international and diplomatic studies, University of Florence, Italy (1986)
  • Degree in international law, University of Florence, Italy (1986)

Declaration of interests

Deputy Head of Legal

Tomasz Jabłonski

Nationality: Polish

Career to date:

Education:

Declaration of interests

Head of Litigation Office

Nathalie Rampal OlmedoNathalie Olmedo

Nationality: Spanish

Career to date:

  • Head of Litigation Office, European Medicines Agency (2015-present)
  • Head of Litigation Office (ad interim), European Medicines Agency (2014-2015)
  • Legal Administrator, European Medicines Agency (2007- 2014)
  • Associate lawyer, Ashurst LLP, Brussels, Belgium (2002-2007)
  • Associate lawyer, Liedekerke Siméon Wessing Houthoff, Brussels, Belgium (2001-2002)

Education:

Declaration of interests

Head of Anti-fraud Office (ad interim)

Stefano MarinoStefano Marino

Nationality: Italian

Career to date:

  • Head of Anti-fraud Office (ad interim), European Medicines Agency (2015-present)
  • Head of Legal, European Medicines Agency (2013-present)
  • Head of Legal Service, European Medicines Agency (2013)
  • Corporate Legal and Intellectual Property Director, Sigma-Tau, Rome, Italy (1997-2013)
  • Chairman, Corporate Governance Committee, Sigma-Tau Pharmaceuticals Inc., Gaithersburg, United States (2012-2013)
  • Board Member and Corporate Secretary, Sigma-Tau Pharmaceuticals Inc., Gaithersburg, United States (2001-2013)
  • Chief Compliance Officer, Sigma-Tau, Rome, Italy (2010-2013)
  • Chairman, Trademark Committee, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium (2005-2013)
  • Member, Intellectual Property Policy Committee, European Federation of Pharmaceutical Industries and Associations, Brussels, Belgium (1998-2011)
  • Intellectual Property Contract Manager, Montell, Milan, Italy (1996-1997)
  • General Counsel, A. Menarini, Florence, Italy (1988-1996)
  • Customs and Excise Officer, Bergamo / Florence, Italy (1986-1987)

Education:

  • Admission to the bar of Italian solicitors (1989)
  • Legal practitioner, Studio Legale M. Siniscalchi, Consenza, Italy (1986-1988)
  • Research fellowship in public law and economics, Italian Parliament, Rome, Italy (1988)
  • Research fellowship in international and diplomatic studies, University of Florence, Italy (1986)
  • Degree in international law, University of Florence, Italy (1986)

Declaration of interests

Head of Long Term and Special Projects Office

Sandra Vanlievendael

Nationality: Belgian

Career to date:

  • Head of Long Term and Special Projects Office, European Medicines Agency (2014-present)
  • Head Pharmaceutical Law Section, European Medicines Agency (2012-2013)
  • Senior Legal Administrator, Legal Service, European Medicines Agency (2006-2012)
  • Legal Administrator, Legal Service, European Medicines Agency (1996-2006)
  • Legal Administrator, European Commission, Directorate-General XII/B/O - Science, Research and Development, Brussels, Belgium (1995-1996)
  • Legal Trainee, European Commission, Directorate-General - Environment, Nuclear Safety and Civil Protection, Brussels, Belgium (1993-1994)

Education:

  • Maîtrise en Droit européen, University of Liège, Belgium (1995)
  • Licentiaat in de Rechten, University of Antwerp, Belgium (1992)
  • Kandidaat in de Rechten, University of Brussels (University Faculties St Aloysius), Belgium (1989)

Declaration of interests

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Head of Programme Management Office

John Stephen ForteJohn Stephen Forte

Nationality: Maltese

Career to date:

  • Head of Programme Management Office, European Medicines Agency (2014-present)

  • Scientific Administrator in Head of Division Support, Procedure Management and Business Support, European Medicines Agency (2013-2014)
  • Scientific Administrator in Head of Unit Support, Pre-authorisation Evaluation of Medicines for Human Use, European Medicines Agency (2004-2013)
  • Quality assurance officer / Assistant quality assurance manager, Pharmamed Ltd, Żejtun, Malta (2002-2004)
  • Pharmacist / Senior pharmacist, Health Division, Valletta, Malta (1992-2002)
  • Radiographer / Senior radiographer, Health Division, Valletta, Malta (1987-1992)

Education:

Declaration of interests

Head of Central Sourcing Office

Sebastian AsprellaSebastian Asprella

Nationality: Italian

Career to date:

  • Head of Central Sourcing Office, European Medicines Agency (2014-present)
  • Head of Information Technology Sourcing Office, European Medicines Agency (2014)
  • Head of Information Technology Office, European Medicines Agency (2013-2014)

  • Head of Information Technology Office (ad interim), European Medicines Agency (2012–2013)
  • Head of Budget and Finance Services (ad interim), European Medicines Agency (2012)
  • Administrative assistant, Information and Communications Technology Division, European Medicines Agency (2006-2012)
  • Administrative assistant, Administration Unit, European Medicines Agency (2001-2006)

Education:

Declaration of interests

Head of Procurement and Contract Office (ad interim)

Caroline MaignenCaroline_Maignen

Nationality: British

Career to date:

  • Head of Procurement and Contract Office (ad interim), European Medicines Agency (2015-present)
  • Contracts and Procurement Support Officer, European Medicines Agency (2009-2015)
  • Contracts Manager, European Medicines Agency (2003-2009)
  • Administrative Assistant, European Medicines Agency (1996-2003)
  • Administrative Assistant, The European Commission Representation in the United Kingdom, London, United Kingdom (1986-1996)

Education:

Declaration of interests

Head of European Union Institutional Liaison (ad interim)

Hilde BooneHilde Boone

Nationality: Belgian

Career to date:

  • Head of European Union Institutional Liaison (ad interim), European Medicines Agency (2014-present)
  • European Union Institutional Liaison Officer, European Medicines Agency (2012-1014)
  • European Medicines Agency Liaison Official, Food and Drug Administration, Washington DC, United States (2010-2012)
  • Regulatory Affairs Advisor, European Medicines Agency (1997-2009)
  • Health Regulatory Affairs Administrator Benelux, Upjohn / Pfizer, Puurs / Brussels, Belgium (1994-1997)
  • Trainee, Upjohn, Puurs, Belgium (1993)

Education:

  • Diploma in European regulatory affairs, Institute for Pharmaceutical Business Administration, Leiden / Amsterdam, the Netherlands (1996)
  • Industrial Pharmacist, University of Antwerp, Belgium / Technische Universität Carolo-Wilhelmina, Braunschweig, Germany (1993)
  • Pharmacist, University of Antwerp, Belgium (1992)

Declaration of interests

Head of Policy and Crisis Management

To be decided.

Head of Access to Documents

Anne-Sophie Henry-EudeAnne-Sophie Henry-Eude

Nationality: French

Career to date:

  • Head of Access to Documents, European Medicines Agency (2014-present)
  • Head of Access to Documents (ad interim), European Medicines Agency (2013-2014)
  • Lecturer, University of Lille, France (2010-present)
  • Scientific Administrator, European Medicines Agency (2001-2013)
  • Regulatory Affairs Manager for Medical Devices, Macopharma, Tourcoing, France (2000-2001)
  • Regulatory Affairs Manager, Sanofi-Synthelabo HQ, Gentilly, France (1999-2000)
  • Trainee, Ribi-ImmunoChem, Hamilton, Montana, United States (1999)
  • Trainee, Schering-Plough Europe, Brussels, Belgium (1998)

Education:

  • Post-graduate in pharmacovigilance and pharmaco-epidemiology, Bordeaux Segalen University, France (2004)
  • Masters in regulatory affairs and pharmaceutical legislation, University of Lille, France (1998)
  • Doctor in pharmacy specialising in industry, University of Lille, France (1999)
  • Masters degree in pharmacology, University of Lille, France (1996)

Declaration of interests

Head of Management Board and Heads of Medicines Agencies (ad interim)

Silvia FabianiSilvia Fabiani

Nationality: Italian

Career to date:

  • Head of Management Board and Heads of Medicines Agencies (ad interim), European Medicines Agency (2014-present)
  • Head of Medicines Agencies Liaison Officer, European Medicines Agency (2012-2014)
  • Chief of Staff Functions for the Director-General, Italian Medicines Agency, Rome, Italy (2010-2012)
  • Italian Alternate Member of the Management Board, European Medicines Agency (2001-2011)
  • Head of International Relations, Italian Medicines Agency, Rome, Italy (2008-2010)
  • Head of Quality Management System, Italian Health Ministry, Directorate-General for Medicines / Italian Medicines Agency, Rome, Italy (2002-2008)
  • Director of Office for European Regulatory Affairs, Italian Health Ministry, Directorate-General for Medicines, Rome, Italy (2001-2002)
  • Administrator in Technical Coordination, European Agency for the Evaluation of Medicinal Products, London, United Kingdom (1994-2000)
  • Assistant to the Administrative Director, Bibliotheca Hertziana, Max-Planck-Institut, Rome, Italy (1985-1989)
  • Press Officer, Fendi, Rome, Italy (1982-1985)

Education:

Declaration of interests

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