Human Medicines Evaluation

The European Medicines Agency's Human Medicines Evaluation Division is responsible for activities related to the scientific, regulatory and procedural management of human medicines evaluation.

This includes ensuring that the evaluation of submissions is performed in a timely manner and with the highest-possible quality.

An organisation chart below shows the full structure of the Human Medicines Evaluation Division.

Organisation chart: Human Medicines Evaluation

List item

Organisation chart: Human Medicines Evaluation (PDF/97.79 KB)

First published: 16/09/2013
Last updated: 01/08/2018

Head of Human Medicines Evaluation

Zaïde Frias

Nationality: Belgian / Portuguese

Career to date:

Head of Human Medicines Evaluation, European Medicines Agency (2016-present)
Head of Human Medicines Research and Development Support, European Medicines Agency (2015-2016)
Head of Human Medicines Research and Development Support (ad interim), European Medicines Agency (2013-2015)
Head of Regulatory Affairs and Best Evidence, European Medicines Agency (2013-present)
Head of Regulatory Affairs, European Medicines Agency (2009-2013)
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

Scientific and Regulatory Management

Jordi Llinares Garcia

Nationality: Spanish

Career to date:

Head of Scientific and Regulatory Management, European Medicines Agency (2016-present)
Head of Product Development Scientific Support, European Medicines Agency (2013-2016)
Head of Orphan Medicines, European Medicines Agency (2009-2013)
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

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, University of Milan, Italy (1997)
Degree in pharmaceutical sciences, University of Milan, Italy (1995)

Declaration of interests

Pavel Balabanov

Nationality: Bulgarian

Career to date:

Head of Central Nervous System and Ophthalmology (ad interim), European Medicines Agency (2018-present)
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 (to be published)

Heidi Maria 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

Francesco Pignatti

Nationality: Italian

Career to date:

Head of Oncology, Haematology and Diagnostics, European Medicines Agency (2009-present)
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

Richard Veselý

Nationality: Slovak

Career to date:

Head of Rheumatology, Respiratory, Gastroenterology and Immunology, European Medicines Agency (2014-present)
Scientific Officer, European Medicines Agency (2009-2014)
Clinical Head of Paediatric Department, Paediatrician, Paediatric Rheumatologist and Immunologist at Children's Faculty Hospital, Košice, Slovakia (2007-2008)
Consultant (locum), Paediatric Rheumatologist, The Leeds Teaching Hospitals National Health Service Trust, Leeds, United Kingdom (2006-2007)
Executive director, BDSR, spol. s r.o., Košice, Slovakia (1995-2003)
Senior Lecturer in Paediatrics and Medical Immunology, Pavol Jozef Šafárik University, Košice, Slovakia (1988-1993)
Paediatrician, Paediatric Rheumatologist and Immunologist, Children's Faculty Hospital, Košice, Slovakia (1981-2007)

Education:

Specialisation in Rheumatology, Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1996)
Specialisation in Medical Immunology Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1992)
Specialisation in Paediatrics 2nd grade Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1989)
Specialisation in Paediatrics 1st grade, Institute for Postgraduate Education of Physicians and Pharmacists, Bratislava, Slovakia (1984)
Doctor of medicine, Pavol Jozef Šafárik University, Košice, Slovakia (1981)

Declaration of interests

Alexios Skarlatos

Nationality: Greek

Career to date:

Head of Labeling Review and Standards Office, European Medicines Agency (2014-present)
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

Sónia Ribeiro

Nationality: Portuguese

Career to date:

Head of Regulatory Affairs, European Medicines Agency (2014-present)
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

Procedure Management

Evdokia Korakianiti

Nationality: Greek

Career to date:

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

Thomas Castelnovo

Nationality: French

Career to date:

Head of Evaluation Procedures A, European Medicines Agency (2014-present)
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 interests

Radhouane Cherif

Nationality: French

Career to date:

Head of Head of Evaluation Procedures B, European Medicines Agency (2018-present)
Head of Telematics and Governance Office, European Medicines Agency (2017-2018)
Head of Telematics Office, European Medicines Agency (2015-2017)
Head of Rheumatology, Respiratory, Gastroenterology and Immunology (ad interim), European Medicines Agency (2013-2015)
Scientific Administrator, European Medicines Agency (2008-2013)
European Regulatory Affairs, Schering-Plough Europe, Brussels, Belgium (2000-2008)

Education:

Master in health economics, University of Lille II / University of Paris V, France (2000)
Master's degree in European regulatory affairs, University of Lille II, France (2000)
Pharmacy degree, Université Catholique de Louvain, Belgium (1998)

Declaration of interests

Iordanis Gravanis

Nationality: Greek

Career to date:

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 interests

Alberto Gañan Jimenez

Nationality: Spanish

Career to date:

Head of Evaluation Procedures D, European Medicines Agency (2014-present)
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

Irene Rager

Nationality: German

Career to date:

Head of Evaluation Procedures E, European Medicines Agency (2014-present)
Regulatory Affairs Officer, European Medicines Agency (2010-2014)
Scientific Administrator, European Medicines Agency (2005-2010)
Group Leader of the Quality Control Unit for Finished Medicinal Products, Merck KGaA, Darmstadt, Germany (2005)
Head of Laboratory Quality Control for Finished Products, Merck KGaA, Darmstadt, Germany (2002-2005

Education:

Doctor of Science in pharmaceutical analysis, Eberhard Karls University of Tübingen, Darmstadt, Germany (2001)
Pharmacy degree, Albert Ludwigs University of Freiburg, Germany (1998)

Declaration of interests

Thomas Girard

Nationality: French

Career to date:

Head of Evaluation Procedures F, European Medicines Agency (2017-present)
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 degree in law, Paris Sud University, France (2005)
Master degree in health law, Paris Sud University, France (2002)
Doctor of pharmacy, Paris Sud University, France (2002)

Declaration of interests

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Human Medicines Evaluation

Organisation chart: Human Medicines Evaluation

Organisation chart: Human Medicines Evaluation (PDF/97.79 KB)

Head of Human Medicines Evaluation

Scientific and Regulatory Management

Procedure Management

How useful was this page?