Human Medicines

The European Medicines Agency's (EMA) Human Medicines Division oversees human medicines throughout their lifecycle. This includes the provision of guidance and advice during medicine development, the marketing authorisation process and the safety monitoring of medicines on the market. It also works to facilitate access to and the optimal use of medicines, for the benefit of patients in the European Union. 

The Division supports the work of the European medicines regulatory network to produce high-quality patient-centred scientific evaluations and in ensuring compliance with good-practice standards. It provides leadership for the Agency's pharmacovigilance system. 

The Division maintains close contact with other decision-makers in healthcare and with international partners, in conjunction with the Agency's international-affairs function.

It provides the secretariat to all EMA committees and working parties that support EMA's work on human medicines.

Organisation chart: Human Medicines

Organisation chart: Human Medicines

Head of Human Medicines

Head of Human Medicines

Alexis Nolte

Nationality: French

Career to date:

• Head of Human Medicines, European Medicines Agency (2020-present)
• Head of Information Management, European Medicines Agency (2015-2020)
• Head of Procedure Management and Business Support, European Medicines Agency (2013-2015)
• Head of Quality of Medicines, European Medicines Agency (2010-2013)
• Head of Product Data Management (ad interim), European Medicines Agency (2009-2010)
• Scientific Administrator, European Medicines Agency (2004-2009)
• Consultant to World Health Organization, Geneva, Switzerland (2003-2004)
• Scientific Administrator, European Medicines Agency (1999-2002)
• Post-doctoral Research Scientist, Pasteur Institute, Paris, France (1997-1998)
• Research Fellow, Free University 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, Free University Berlin, Germany (1996)
• Doctor of Pharmacy, University of Nancy, France (1992)
• Masters degree in biochemistry, University of Nancy, France (1990)
   

Declaration of interests: Alexis Nolte

Scientific Adviser on Human Medicines

Spiridon Vamvakas

Nationality: German / Greek

Career to date:

• Scientific Adviser on Human Medicines, European Medicines Agency (2020-present)
• Deputy Head of Product Development Scientific Support, European Medicines Agency (2015-2020)
• Head of Scientific Advice, European Medicines Agency (2009-2020)
• 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: Spiridon Vamvakas

Scientific Adviser Oncology

Francesco Pignatti

Nationality: Italian

Career to date:

• Scientific Adviser Oncology, European Medicines Agency (2023-present)
• Head of Oncology and Haematology, European Medicines Agency (2020-present)
• Head of Oncology, Haematology and Diagnostics, European Medicines Agency (2009-2020)
• Head of Safety and Efficacy of Medicines (ad interim), 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: Francesco Pignatti

Therapeutic Areas

Head of Therapeutic Areas

Francesca Day

Nationality: Italian / British 

Career to date:

• Head of Therapeutic Areas Department, European Medicines Agency (2021-present)
• Operational Lead, Office for Vaccines and Therapies for Infectious Diseases, European Medicines Agency (2020-2021)
• Regulatory Affairs Director, AstraZeneca A.B., Gothenburg, Sweden (2019-2020)
• Director, Regulatory Affairs, Gilead Sciences International Ltd, Cambridge, UK (2018-2019)
• Associate Director, Regulatory Affairs, Gilead Sciences International Ltd, Cambridge, UK (2017-2018)
• Senior Manager, Regulatory Affairs, Gilead Sciences International Ltd, Cambridge, UK (2016-2017)
• Manager, Regulatory Affairs, Gilead Sciences International Ltd, Cambridge, UK (2014-2016)
• Associate Manager, Regulatory Affairs, Gilead Sciences International Ltd, Cambridge, UK (2013-2014)
• Senior Associate, Regulatory Affairs, Gilead Sciences International Ltd, Cambridge, UK (2011-2013)
• Regulatory and Drug Safety Manager, Chroma Therapeutics Ltd, Abingdon, UK (2010-2011)
• Regulatory and Drug Safety Officer, Chroma Therapeutics Ltd, Abingdon, UK (2009-2010)
• Medicinal Chemistry Team Leader, Chroma Therapeutics Ltd, Abingdon, UK (2004-2009)
• Investigator, Vertex Pharmaceuticals Europe Ltd, Abingdon, UK (2000-2004)

Education

• Doctor of Philosophy in Organic Chemistry, University of St. Andrews, UK (2001)
• Bachelor of Science in Chemistry, University of St. Andrews, UK (1997)

Declaration of interests: Francesca Day

Head of Oncology and radiopharmaceuticals

Elias Pean

Nationality: French

Career to date:

• Head of Oncology and radiopharmaceuticals (2023-present)
• Scientific Administrator, European Medicines Agency (2009-2023)
• International Regulatory Affairs Manager, Roche, Basel, Switzerland (2007-2009)
• Regulatory Affairs Manager, Eli Lilly & Co, Paris, France (2003-2007)

Education

• Master in global drug development and registration, University of Paris-Saclay (2003) • Doctor of pharmacy, University Claude Bernard Lyon I, France (2003)

Declaration of interests : Elias Pean

Head of Vaccines and Therapies for Infectious Diseases (ad interim)

Thomas Larsson

Nationality: Swedish

Career to date:

• Head of Vaccines and Therapies for Infectious Diseases (ad interim), European Medicines Agency (2024 - Current)
• Scientific Administrator, European Medicines Agency (2006-2024)
• Trainee,  Human Pre-Authorisation Unit, European Medicines Agency (2006)
• Trainee, DG Research, European Commission, Belgium (2005-2006)
• Laboratory assistant, Uppsala Universitet, Sweden (2005)

Education:

• Master of Science in molecular biology, Uppsala Universitet, Uppsala, Sweden (2005)
• Bachelor of Science, University of Warwick, Coventry, United Kingdom (2002)

Declaration of interest to be published soon

Head of Therapies for Neurological and Psychiatric Disorders

Pavel Balabanov

Nationality: Bulgarian

Career to date:

• Head of Therapies for Neurological and Psychiatric Disorders, European Medicines Agency (2020-present)
• Head of Central Nervous System and Ophthalmology, European Medicines Agency (2019-2020)
• Head of Central Nervous System and Ophthalmology (ad interim), European Medicines Agency (2018-2019)
• EMA product lead, Central Nervous System and Ophthalmology, European Medicines Agency (2013-2018)
• Scientific administrator, Scientific Advice, European Medicines Agency (2008-2013)
• Clinical neurologist, University Hospital, Plovdiv, Bulgaria (2003-2008)

Education:

• Doctor of Philosophy (PhD) in Neurology and Pharmacoeconomics, Medical University, Plovdiv, Bulgaria (2007)
• Specialist in Neurology, University hospital, Plovdiv, Bulgaria (2007)
• Medical Doctor, Medical University, Sofia, Bulgaria (2001)

Declaration of interests: Pavel Balabanov

Head of Therapies for Endocrine and cardiovascular diseases

Heidi Janssen

Nationality: Belgian

Career to date:

• Head of Therapies for Endocrine and cardiovascular diseases, European Medicines Agency (2020-present)
• Head of Endocrinology, Metabolism and Cardiovascular, European Medicines Agency (2011-2020)
• 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: Heidi Janssen

Head of Therapies for Immune and Inflammatory Diseases

Thomas Castelnovo

Nationality: French

Career to date:

• Head of Therapies for Immune and Inflammatory Diseases, European Medicines Agency (2020-present)
• Head of Evaluation Procedures A, European Medicines Agency (2014-2020)
• Scientific Administrator, European Medicines Agency (2008-2014)
• European Regulatory Affairs Manager, Merck Serono, Geneva, Switzerland (2005-2008)
• European Regulatory Affairs Associate, Parexel, London, United Kingdom (2004-2005)
• International Regulatory Affairs Executive, GlaxoSmithKline, London, United Kingdom (2003-2004)

Education:

• Masters degree in international drug development and registration, University of Paris, France (2003)
• Pharmacy degree, University Claude Bernard Lyon I, France (2002)

Declaration of interest: Thomas Castelnovo

Head of Advanced therapies and haemato-oncology

Caroline Pothet 

Nationality: French / British

Career to date:

• Advanced therapies and haematological diseases, European Medicines Agency (2022-present)
• Regulatory Affairs Senior Specialist (2020-2022)
• Senior Director, Global Matrix Lead, Immuno-Inflammation, GlaxoSmithKline BV, Amsterdam, The Netherlands (2018-2020)
• Director, Global Regulatory, Immuno-Inflammation, GlaxoSmithKline, Uxbridge, United Kingdom (2013-2018)
• Manager, Regulatory Affairs, Oncology, GlaxoSmithKline, Uxbridge, UK (2004-2013)
• Regulatory Project Manager, Central & Eastern Europe, GlaxoSmithKline, Greenford, UK (2002-2004)
• Senior Regulatory Associate, Parexel, Uxbridge, UK (2001-2002)
• Regulatory Intelligence Adviser, Ipsen, London, UK (2000-2001)
• Regulatory Affairs Executive, Policy and Intelligence, Glaxo Wellcome, Greenford, UK (1998-2000)
• Hospital Pharmacy Internship, Clamart, France (1996-1997)

Education:

• Master in global drug development and registration, Paris-Sud University, France (1998)
• Doctor of Pharmacy, Paris-Sud University, France (1998)

Declaration of interests: Caroline Pothet

Scientific Evidence Generation

Head of Scientific Evidence Generation

Michael Berntgen

Nationality: German

Career to date:

• Head of Scientific Evidence Generation, European Medicines Agency (2020-present)
• Head of Product Development Scientific Support, European Medicines Agency (2016-2020)
• 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:

• Master of drug regulatory affairs, Rhenish Friedrich-Wilhelms-University, Bonn, Germany (2003)
• Doctor of Science in pharmaceuticals, Westphalian Wilhelm's University Münster, Germany (1997)
• Pharmacy degree, Philipps University Marburg, Germany (1993)

Declaration of interests: Michael Berntgen

Head of Scientific Advice

Iordanis Gravanis

Nationality: Greek

Career to date:

• Head of Scientific Advice, European Medicines Agency (2020-present)
• Head of Evaluation Procedures C, European Medicines Agency (2014-present)
• Scientific Administrator, European Medicines Agency (2008-2014)
• Research Assistant, Stony Brook University, New York, United States (2002-2007)
• Primary care physician, Ioannina, Greece (1998-2001)

Education:

• Doctor of Philosophy in molecular and cellular pharmacology, Stony Brook University, New York, United States (2007)
• Medical degree, University of Ioannina, Greece (1998)

Declaration of interest: Iordanis Gravanis

Head of Paediatric Medicines

Ralph Bax

Nationality: German

Career to date:

• Head of Paediatric Medicines, European Medicines Agency (2018-present)
• Head of Paediatric Medicines (ad interim), European Medicines Agency (2017-2018)
• Scientific Officer, Paediatric Medicines Office, European Medicines Agency (2007-2016)
• Lecturer, Paediatric Neurology and Neonatology, Lead Neurodevelopment Service, Children's University Hospital, Technische Universität München (TU Munich), Germany (2001-2007)
• Research Fellow, Children's University Hospital, TU Munich, Germany (1998-2000)
• Paediatric training, Children's University Hospital, TU Munich, Germany (1992-1998)

Education:

• Master in Health Care Management, Universities of Kaiserslautern and Witten-Herdecke, Germany (2006)
• Doctor of Medicine, Technische Universität München (TU Munich), Germany (1992)
• State examination Human Medicine, Technische Universität München (TU Munich), Germany (1990)

Declaration of interests: Ralph Bax

Head of Orphan Medicines

Kristina 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:

• Master of Medicine in Pharmaceutical Bioscience, University of Gothenburg, Sweden (2002)

Declaration of interests: Kristina Larsson

Head of Translational Sciences

Corinne de Vries

Nationality: Dutch

Career to date:

• Head of Translational Sciences, European Medicines Agency (2020-present)
• Head of Science and Innovation Support, European Medicines Agency (2017-2020)
• Head of Science and Innovation Support (ad interim), European Medicines Agency (2015-2017)
• 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:

• Master of Arts in medical ethics and law, King's College London, United Kingdom (2006)
• Doctor of Philosophy in mathematics and physics, University of Groningen, the Netherlands (1998)
• Registered pharmacist, University of Groningen, the Netherlands (1998)
• Master of Science in pharmacy, University of Groningen, the Netherlands (1992)

Declaration of interests: Corinne de Vries

Quality and Safety of Medicines

Head of Quality and Safety of Medicines

Evdokia Korakianiti

Nationality: Greek

Career to date:

• Head of Quality and Safety of Medicines, European Medicines Agency (2020-present)
• Head of Inspections (ad interim), European Medicines Agency (2021-present)
• Head of Procedure Management, European Medicines Agency (2013-present)
• Head of Evaluation Procedures B (ad interim), European Medicines Agency (2017-2018)
• Head of Chemicals, European Medicines Agency (2012-2013)
• 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: Evdokia Korakianiti

 

Head of Pharmaceutical Quality

Veronika Jekerle

Nationality: German

Career:

• Head of Pharmaceutical Quality, European Medicines Agency (2020-present)
• Quality Specialist and Scientific Secretariat to Biologics Working Party (BWP), Specialised Scientific Disciplines, European Medicines Agency (2014-2020)
• Scientific Administrator in Pre-authorisation, Quality of Medicines, European Medicines Agency (2007-2014)
• Scientific Administrator in Regulatory Affairs and Post-authorisation Safety / Efficacy, European Medicines Agency (2006-2007)
• Trainee in Pharmacovigilance, European Medicines Agency (2006)
• Post-graduate Visiting Research Fellow, Faculty of Pharmacy, University of Toronto, Canada (2002, 2004)
• Research Fellow and Teaching Assistant, The German Research Foundation (DFG), University of Bonn, Germany (2003-2006)

Education

• Doctor of Philosophy in Molecular Pharmacology and Drug Discovery, University of Bonn, Germany (2006)
• Approbation as Pharmacist, Philipps-University of Marburg, Germany (2003)

Declaration of interests: Veronika Jekerle

Head of Inspections

Peter Twomey

Nationality: Irish

Career:

• Head of Inspections, European Medicines Agency (2022-present)
• Good clinical practice (GCP) /Pharmacovigilance Inspection Manager, Health Products Regulatory Authority, Dublin, Ireland (2019 – 2022)
• Good clinical practice (GCP) / Pharmacovigilance Inspector, Health Products Regulatory Authority, Dublin, Ireland (2017 – 2019)
• Pharmacovigilance Inspector, Medicines and Healthcare Products Regulatory Agency, London, UK (2015 – 2017)
• Scientific Advisor, A Menarini Pharmaceuticals Ireland, Dublin, Ireland (2014)
• Qualified Person for Pharmacovigilance (QPPV) and Pharmacovigilance Manager, Athlone Laboratories, Co Roscommon, Ireland (2012 – 2014)
• Responsible Person for Pharmaceutical Wholesaling, GAP Pharmaceuticals, Co Roscommon, Ireland (2012 – 2013)
• Trainee in Manufacturing and Quality Compliance, European Medicines Agency (2011 - 2012)
• Pharmacy Intern in Pharmaceutical Assessment, Irish Medicines Board (now known as the HPRA), Dublin, Ireland (2011)
• Good Manufacturing Practice (GMP) Business Unit Assistant, Schering-Plough / MSD, Cork, Ireland (2009)

Education

• Bachelor of Arts in Law, Technological University of the Shannon, Athlone, Ireland (2022)
• Bachelor of Laws, Open University, Milton Keynes, UK (2019)
• Master of Pharmacy, Royal College of Surgeons in Ireland, Dublin, Ireland (2011)
• Bachelor of Science in Pharmacy, Royal College of Surgeons in Ireland, Dublin, Ireland (2010)

Declaration of interests: Peter Twomey

Head of Pharmacovigilance

Georgy Genov

Nationality: Bulgarian

Career to date:

• Head of Pharmacovigilance, European Medicines Agency (2020-present)
• Head of Quality and Safety of Medicines (ad interim), European Medicines Agency (2022-2023)
• Head of Signal and Incident Management, European Medicines Agency (2016-2020)
• Head of Signal Management, European Medicines Agency (2013-2016)
• Head of Signal Detection and Data Analysis, European Medicines Agency (2012-2013)
• Head of Signal Detection and Data Analysis (ad interim), 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: Georgy Genov

Head of Referrals

Véronique Le Ber

Nationality: French

Career to date:

• Head of Referrals, European Medicines Agency (2021-present)
• Head of Referrals (ad interim), European Medicines Agency (2021-present)
• Scientific Administrator, European Medicines Agency (2009-2021)
• Regulatory Affairs Manager, Pierre Fabre Medicaments, Paris, France (2009)
• Trainee, Pre-authorisation Safety and Efficacy, European Medicines Agency (2008-2009)
• Trainee, Worldwide Regulatory Strategy-EU, Pfizer Limited, Sandwich, United Kingdom (2008)
• Trainee, Laboratoires Servier, Paris, France (2007)
• Hospital pharmacy trainee, Hospital Centre Sud Francilien, Corbeil-Essonnes, France (2006-2007)

Education:

• Masters degree in international drug development and registration, Paris Sud University, France (2008)
• Pharmacy degree, Paris Sud University, France (2008)

Declaration of interests: Veronique Le Ber

Committees and Quality Assurance

Head of Committees and Quality Assurance

Alberto Gañan Jimenez

Nationality: Spanish

Career to date:

• Head of Committees and Quality Assurance, European Medicines Agency (2023-present)
• Head of Committees and Quality Assurance (ad interim), European Medicines Agency (2022-2023)
• Head of Procedures, European Medicines Agency (2020-2022)
• Head of Evaluation Procedures D, European Medicines Agency (2014-2020)
• Scientific Administrator, European Medicines Agency (2006-2014)
• Business Intelligence Analyst, AstraZeneca, Madrid, Spain (2004-2006)
• Public Health Inspector, Junta de Castilla y Leon, Soria, Spain (2003-2004)
• Research fellow, Department of Molecular and Cell Biology, University of Zaragoza, Spain (1999-2003)

Education:

• Master in management of pharmaceutical and healthcare industries, Instituto de Empresa, Madrid, Spain (2004)
• Doctor of Philosophy in molecular and cell biology, University of Zaragoza, Spain (2003)
• Biochemistry degree, University of Salamanca, Spain (1999)
• Doctor of pharmacy, University of Salamanca, Spain (1997)

Declaration of interests: Alberto Ganan Jimenez

Head of Meeting Secretariat

Sónia Ribeiro

Nationality: Portuguese

Career to date:

• Head of Referrals (ad interim), European Medicines Agency (2022-2023)
• Head of Meeting Secretariat, European Medicines Agency (2022-present) 
• Head of Product Portfolio, European Medicines Agency (2020-2022)
• Head of Regulatory Affairs (ad interim), European Medicines Agency (2020)
• Head of Regulatory Affairs, European Medicines Agency (2014-2020)
• Regulatory Affairs Adviser, European Medicines Agency (2009-2014)
• Scientific Administrator, European Medicines Agency (2005-2009)
• National expert on Secondment, Scientific Administrator, European Medicines Agency (2004-2005)
• Scientific Administrator, Infarmed, Lisbon, Portugal (2000-2004)

Education:

• Post-graduation degree in Economic Evaluation of Medicines, Instituto Superior de Economia e Gestão e Faculdade de Farmácia da Universidade de Lisboa, Portugal (2002)
• Degree in Pharmaceutical sciences, Faculdade de Farmácia da Universidade de Lisboa, Portugal (2000)

Declaration of interests: Sonia Ribeiro

Head of Procedures

Virginia Rojo Guerra

Nationality: Spanish

Career to date:

• Head of Procedures Office, European Medicines Agency (2023-present)
• Head of Procedures Office (ad interim), European Medicines Agency (2022-2023)
• Scientific Administrator, European Medicines Agency (2020-2022)
• CMC Regulatory Affairs Specialist, Novo Nordisk, Copenhagen, Denmark (2019-2020)
• Manager CMC Regulatory Affairs, GSK, London, UK (2013-2019)
• Regulatory Affairs Senior Officer, Fresenius Kabi, Barcelona, Spain (2010-2013)
• Regulatory Affairs Senior Officer, Ipsen Pharma, Barcelona, Spain (2008-2010)
• Regulatory Affairs Officer, Laboratorios SALVAT, Esplugues de Llobregat, Spain (2005-2008)
• Regulatory Affairs Junior Officer, Combino Pharm, Sant Joan Despí, Spain (2003-2005)
• Regulatory Affairs Junior Officer, B.Braun Medical, Rubí, Spain (2002-2003)
• Trainee Regulatory Affairs, Alcon Cusí, El Masnou, Spain (2002)

Education

• Master in Pharmaceutical and Healthcare Industry, CESIF, Barcelona, Spain (2002)
• Pharmacy Degree, University of Barcelona, Barcelona, Spain (1999)

Declaration of interests: Virginia Rojo Guerra

Head of Labelling Office

Alexios Skarlatos

Nationality: Greek

Career to date:

• Head of Labelling, European Medicines Agency (2020-present)
• Head of Committees and Quality Assurance (ad interim), European Medicines Agency (2021-2022)
• Head of Labelling Review and Standards Office, European Medicines Agency (2014-2020)
• Head of Product Information Quality, European Medicines Agency (2009-2014)
• 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: Alexios Skarlatos

Head of Regulatory Affairs

Thomas Girard

Nationality: French

Career to date:

• Head of Regulatory Affairs (2020-present)
• Head of Referrals, European Medicines Agency (2020)
• Head of Evaluation Procedures F, European Medicines Agency (2017-2020)
• Head of Evaluation Procedures F (ad interim), European Medicines Agency (2017)
• Regulatory Affairs Officer, European Medicines Agency (2009-2017)
• Regulatory Intelligence Officer, Novartis Pharma (2008-2009)
• Regulatory Affairs Executive, Leo Pharma (2002-2008)

Education:

• Master's degree in law, Paris Sud University, France (2005)
• Master's degree in health law, Paris Sud University, France (2002)
• Doctor of pharmacy, Paris Sud University, France (2002)

Declaration of interests: Thomas Girard

Head of Expert Panels and Groups

Silvy da Rocha Dias

Nationality: Portuguese

Career to date:

• Head of Expert Panels and groups, European Medicines Agency (2023-present)
• Head of Expert Panels and groups (ad interim), European Medicines Agency (2022-2023)
• Programme Manager Senior Specialist, European Medicines Agency (2021-2022)
• Committee Manager, European Medicines Agency (2019-2021)
• Scientific Administrator, European Medicines Agency (2007-2019)
• Medical writer, Medicus International, London, United Kingdom (2006-2007)
• Post-doctoral scientist, Institute of Cancer Research, United Kingdom (2002-2006)
• Doctor of Philosophy (PhD) visiting fellow, Imperial College, London, United Kingdom (2000-2002)
• Scientific Officer, Dana Farber Cancer Institute, Boston, United States (1996-2000)
• Visiting fellow, The Netherlands Cancer Institute, Amsterdam, The Netherlands (1996)

Education:

• Doctor of Philosophy (PhD) in Immunology, University of Porto, Porto Portugal (2003)
• Master’s degree in Immunology, University of Porto, Porto, Portugal (1996)
• Bachelor’s degree in Microbiology and Immunology, McGill University, Canada (1993)

Declaration of interests: Silvy da Rocha Dias

Head of Process Management

Francisco Peñaranda Fernández

Nationality: Spanish

Career to date:

• Head of Process Management Office, European Medicines Agency (2024 – present)
• Lead Process Manager, European Medicines Agency (2019 – 2024)
• Head of Data Management Department, European Medicines Agency (2014 – 2019)
• Head of Parallel Distribution and Certificates Office, European Medicines Agency (2009 – 2014)
• Scientific Administrator, European Medicines Agency (1997 – 2009)
• Quality Assurance manager, KAO Corporation, Spain (1996-1997)
• Quality Assurance specialist, Chiesi Pharmaceuticals, Spain (1987 – 1996)

Education:

• University degree in Chemistry, Universitat Central de Barcelona, Spain (1982-1986)
• Master in Total Quality Management, Quality Assurance Institute Barcelona, Spain (1994 -1996)

Declaration of interests: Francisco Penaranda Fernandez