Advisory functions

Hilde Boone

Nationality: Belgian

Career to date:

• Head of Institutional and Policy, European Medicines Agency (2022-present)
• Head of Institutional and Policy (ad interim), European Medicines Agency (2021-2022)
• Head of European Union Institutional Liaison, European Medicines Agency (2017-2021)
• Head of European Union Institutional Liaison (ad interim), European Medicines Agency (2014-2017)
• 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

Martin Harvey Allchurch 

Nationality: British / Italian

Career to date:

• Head of International Affairs, European Medicines Agency (2021-present)
• Principal International Affairs Officer, European Medicines Agency (2020-2021)
• Head of Communications, Unitaid, Geneva, Switzerland (2020)
• Governance and Executive Board Manager, Unitaid, Geneva, Switzerland, (2019-2020)
• Principal International Affairs Officer, European Medicines Agency (2014-2019)
• Head of Communications, European Medicines Agency (2012-2014)
• Head of Office for the Executive Director, European Medicines Agency (2009-2012)
• Head of Executive Support, European Medicines Agency (2004-2009)
• Legal Administrator, European Medicines Agency (1995-2004)
• Senior Consultant, Interel, Brussels, Belgium (1992-1995)

Education:

• Master of International and European Law, Vrije Universiteit Brussel, Belgium (1991)
• Bachelor of Laws, University of Dundee, UK (1990)

Declaration of interests

Franck Diafouka

Career to date:

• Head of Audit (ad interim), European Medicines Agency (2022 – present)
• Senior Lead Audit, European Medicines Agency (2015 – 2022)
• Member of Audit Advisory Committee, European Medicines Agency (2009 – 2012)

• Head of Division Support (Inspections and Human Medicines Pharmacogivilance), European Medicines Agency (2013 – 2015)
• Head of Department Support (Pharmacovigilance and Risk Management), European Medicines Agency (2010 – 2013)
• Programme Manager Pharmacovigilance legislation, European Medicines Agency (2009 – 2015)
• Scientific Administrator, European Medicines Agency (2006 – 2010)
• Pharmacist - Dispensary Manager, Boots The Chemist, London, United Kingdom (2005 – 2006)
• Quality Control Manager / Team Leader, Bristol Myers Squibb, Paris, France (2004 – 2005)
• Pharmacist Pharmacovigilance / Medical Information (temporary), Lundbeck, Paris, France (2003)
• Quality Assurance Manager (temporary), Opodex pharmaceutical, Paris, France (2003)
• Research Associate, University Hospital, Montpellier, France (2000 – 2002)
• Research Associate (internship), University Hospital, Nimes, France (1999 – 2000)

Education:

• Certified Data Management Professional (CDMP) (2021)
• Certified Information Security Manager (CISM) (2021)
• Certified Government Auditing Professional (CGAP) (2016)
• Certified Lead Auditor ISO 9001:2015 (2015)
• Master in Entrepreneurship and Innovative Project Management, Institut d’Administration des Entreprises, Montpellier, France (2001 – 2002)
• Docteur en Pharmacie (Pharmacy degree), University of Montpellier, France (1994 – 2002)

Declaration of interest

Stefano 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

Sandra Vanlievendael

Nationality: Belgian

Career to date:

• Head of Pharma Law and Support to Core Business Office, European Medicines Agency (2020-present)
• Head of Long Term and Special Projects Office, European Medicines Agency (2014-2020)
• 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

Chiara Bortoluzzi

Nationality: Italian / French

Career:

• Head of General Affairs and Anti-Fraud, European Medicines Agency (2020-present)
• Legal Adviser and Anti-Fraud Examiner, European Medicines Agency (2017-2020)
• Legal Officer, European Food Safety Authority, Parma, Italy (2016-2017)
• Legal Adviser, European Medicines Agency (2014-2016)
• Policy Officer for the Italian Presidency of the Council of the EU, Permanent Representation of Italy to the EU, Brussels, Belgium (2014)
• Legal Officer (trainee), Directorate-General for Health & Food Safety (DG SANTE), European Commission, Brussels, Belgium (2013-2014)
• Research Assistant to the Jean Monnet Chair of EU Law and EU Risk Regulation, HEC University, Paris, France (2013-2014)
• Researcher in EU law, Pharmaceutical law and private law, University Paris II Panthéon-Assas, Paris, France (2010-2013)
• Lawyer in training, Freshfields Bruckhaus Deringer, Rome, Italy (2011-2012)
• Lawyer in training, Fabio Anselmo & Partners, Ferrara, Italy (2010-2012)
• Research Assistant, Social Sciences Department, École Normale Supérieure, Paris, France (2009)
• Summer Associate, Cleary Gottlieb, Brussels, Belgium (2008)
• Research Assistant, Interdisciplinary Laboratory Rights & Rules (LIDER-lab), Sant’Anna School of Advanced Studies, Pisa, Italy (2007)

Education

• Certified Information Privacy Professional/Europe (CIPP/E), International Association of Privacy Professionals, Portsmouth, United States (2019)
• Data Protection Officer certification, Maastricht University, Faculty of Law, Maastricht, Netherlands (2019)
• Certified Anti-Fraud Examiner, Association of Certified Fraud Examiners, Austin, United States (2016)
• Admission to the Italian bar (2015)
• Doctor of Philosophy (Ph.D.) in Law, University Paris II Panthéon-Assas / Sant’Anna School of Advanced Studies, Paris, France / Pisa, Italy (2017)
• Master of Laws in European Law, College of Europe, Bruges, Belgium (2011)
• Master Research in European Comparative Law, University Paris II Panthéon-Assas, Paris, France (2010)
• Graduate Diploma (Diplôme des grandes écoles), Social Sciences, École Normale Supérieure, Paris, France (2010)
• Undergraduate and Graduate  Diploma, Social Sciences and Law, Sant’Anna School of Advanced Studies, Pisa, Italy (2010)
• Bachelor of Laws and Master of Laws, University of Pisa, Pisa, Italy (2010)

Declaration of interests

Spyridon Drosos

Nationality: Greek

Career to date:

• Head of Litigation Office, European Medicines Agency (2020-present)
• Legal Administrator, European Medicines Agency (2016-2020)
• Visiting lecturer, Catholic University of Lille (Paris campus), Paris, France (2015-present)
• Trainee, European Medicines Agency, London, United Kingdom (2015)
• Trainee, Legal Service of the European Commission, Brussels, Belgium (2013)
• Researcher, European University Institute (EUI), Florence, Italy (2010-2013)

Education:

• Visiting Scholar, UC Berkeley School of Law, University of California, Berkeley, United States of America (2012)
• Master in Comparative, European and International Laws, European University Institute (EUI), Florence, Italy (2010)
• Master in Environmental Law and Policy, University College London (UCL), London, United Kingdom (2009)
• Bachelor of Laws, University of Athens, Athens, Greece (2008)

Declaration of interests

Steffen Thirstrup 

Nationality: Danish

Career to date:

• Chief Medical Officer, European Medicines Agency (2022-present)
• Director, NDA Advisory Services, NDA Group AB, Upplands Väsby, Sweden (2013-2022)
• Affiliate Professor, University of Copenhagen, Faculty of Health and Medical Sciences, Denmark (2013)
• Head of Institute, Danish Medicines Agency, Institute of Rational Pharmacotherapy, Copenhagen, Denmark (2009-2011)
• Head of Licensing Department, Danish Medicines Agency, Licensing Department, Copenhagen, Denmark (2011-2013)
• Member of CHMP, Danish Medicines Agency, Copenhagen, Denmark (2004-2009)
• Member of CAT, Danish Medicines Agency, Copenhagen, Denmark (2008-2009)
• Chief Medical Officer, Danish Medicines Agency, Copenhagen, Denmark (2004-2009)
• Co-Chair of EC Working Group on Market Access of Biosimilars under the EU Platform on Market Access of Medicines in the EU, Danish Medicines Agency, Copenhagen, Denmark (2011-2013)
• Specialist Registrar, University Hospital Copenhagen, Hvidovre, Denmark (2003-2004)
• Senior House Officer, University Hospital Copenhagen, Rigshospitale and Hvidovre, Denmark (2001-2003)
• Medical Officer, Danish Medicines Agency, Institute for Rational Pharmacotherapy, Copenhagen, Denmark (2000-2001)
• Senior House Officer, University Hospital Aarhu, Denmark (1998-1999)
• Doctor of Philosophy student, University of Aarhus, Institute for Pharmacology, Denmark (1995-1997)
• Junior House Officer, Regional Hospitals, Viborg Amt, Denmark (1993-1994)

Education

• Doctor of Philosophy in Medicine, Pharmacology, University of Aarhus, Denmark (1995-1997)
• Medicine Degree, University of Aarhus, Denmark (1986-1993)
• Board-certified Specialist in Clinical Pharmacology, National Board of Health, Denmark (2002)
• License to practice as a physician, National Board of Health, Denmark (1995)

Declaration of interests

Marco Cavaleri

Nationality: Italian

Career to date:

• Head of Health Threats and Vaccines Strategy, European Medicines Agency (2020-2022)
• Head of Biological Health Threats and Vaccines Strategy, European Medicines Agency (2020-2022)
• Head of Anti-infectives and Vaccines, European Medicines Agency (2009-2020)
• 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, University of Milan, Italy (1997)
• Degree in pharmaceutical sciences, University of Milan, Italy (1995)

Declaration of interests

Elias Tavares

Nationality: Portuguese

Career to date:

• Head of Information Security, European Medicines Agency (2017-present)
• Head of Information Security (ad interim), European Medicines Agency (2015-2017)
• IT Security Officer, European Medicines Agency (2012-present)
• Security Administrator, European Medicines Agency (2009-2012)
• Head of IT Infrastructure, Infarmed, Lisbon, Portugal (2004-2008)
• Infrastructure Coordinator, Infarmed, Lisbon, Portugal (2003-2004)
• Security and Network Administrator, Lisbon, Portugal (1996–2003)

Education:

• Degree in Systems and Computer Engineering, Instituto Superior Técnico, Lisbon, Portugal (1996)

Declaration of interests