The Digital Business Transformation task force drives complex, digital change initiatives that impact on EMA's strategy, operational structure and operations in relation to the European medicines regulatory network, its partners and stakeholders. This includes adapting EMA operations to fundamental changes brought by legislative initiatives, digital technologies and global trends to meet stakeholders’ needs and expectations.

The Data Analytics and Methods task force builds up capability and capacity within EMA and across the European medicines regulatory network to deliver robust clinical evidence for benefit-risk decision-making on medicines. This is achieved through:

  • supporting a strategy to transform clinical trials in Europe;
  • providing expert scientific advice on products under development;
  • strengthening support for marketing authorisation assessments;
  • providing expert methods advice and data analysis for products on the market. 

The Regulatory Science and Innovation task force enables the continuous ‘future-proofing’ of the Agency and the European medicines regulatory network. This is done by addressing key scientific and technological trends and their translation through the development of EMA’s regulatory science strategy, planning and governance. It seeks to offer an enhanced first point of contact service to developers, in particular small and medium-sized enterprises (SMEs) and academia.

The task forces remain flexible to adapt as required by the Agency. 

Organisation chart: Task forces

Digital Business Transformation

Zaïde Frias

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Nationality: Belgian / Portuguese

Career to date:

  • Head of Digital Business Transformation, European Medicines Agency (2020-present)
  • Head of Human Medicines Evaluation, European Medicines Agency (2016-2020)
  • 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:

Declaration of interests: Zaide Frias

To be appointed.

To be appointed.

Jean-Michel Becar

Jean-Michel Becar

Nationality: French

Career to date:

  • Head of Portfolio Management Office, European Medicines Agency (2023-present)
  • Head of Portfolio Office, European Medicines Agency (2018-2023)
  • Programme Manager Consultant, JM-Key-CTO Sari, Luxembourg (2013-2017)
  • Head of Project Management Office and Governance Section, International Atomic Energy Agency, Vienna, Austria (2015-2013)
  • Operations Director, GMO Internet Group, Tokyo, Japan (2001-2005)
  • Project manager, European Telecommunications Standards Institute, Valbonne, France (1993-2000)
  • Application developer / Team leader, Capgemini, Nice, France (1990-1993)

Education:

Declaration of interests: Jean-Michel Becar

Mireia Castillon

Nationality: Spanish

Career to date:

  • Head of Lean Agile Centre of Excellence (ad interim), European Medicines Agency (2023-present)
  • Digitalisation Transformation Programme Manager, European Medicines Agency (2017-2023)
  • Patient Registries Project Manager, European Medicines Agency (2016-2017)
  • EU Network Training Centre Project Manager, European Medicines Agency (2014-2016)
  • IT Liaison Officer, European Medicines Agency (2013-2014)
  • Head of Unit Support (Veterinary Medicines and Product Management), European Medicines Agency (2011-2013)
  • Trainee (Pharmacovigilance and Risk Management), European Medicines Agency (2010-2011)
  • Quality Assurance Officer (internship), Sanofi, Barcelona, Spain (2009-2010)
  • Clinical Pharmacist (internship), Taipei Medical University Hospital, Taiwan (2009)
  • Clinical Pharmacist (internship), Saint-Pierre Hospital, Brussels, Belgium (2008-2009)
  • Hospital Pharmacist (internship), Arnau de Vilanova Hospital, Lleida, Spain (2007)
  • Trainee, Quality lab, San Miguel Brewery, Lleida, Spain (2006)

Education

Declaration of interests: Mireia Castillon

Data Analytics and Methods

Peter Arlett

Peter Arlett portrait photo

Nationality: British / Spanish

Career to date:

  • Head of Data Analytics and Methods Task Force, European Medicines Agency (2020-present)
  • Head of Pharmacovigilance and Epidemiology Department, European Medicines Agency (2016-2020)
  • Head of Pharmacovigilance, European Medicines Agency (2013-2016)
  • Head of Pharmacovigilance and Risk Management Sector, European Medicines Agency (2008-2013)
  • 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:

  • Honorary Professor, London School of Hygiene and Tropic Medicine, United Kingdom (2020)
  • Fellow of the Royal College of Physicians of Edinburg, United Kingdom (2017)
  • Degree in medicine, University College London, United Kingdom (1991)

Declaration of interests: Peter Arlett

Patrice Verpillat

portrait_patrice_verpillat.jpg

Nationality: French

Career to date:

  • Head of Real World Evidence, European Medicines Agency (2023-present)
  • Head of Global Epidemiology, Merck Healthcare KGaA, Darmstadt, Germany (2017-2023)
  • Head of Epidemiology Oncology & Analysis, Boehringer-Ingelheim GmbH, Ingelheim am Rhein, Germany (2014-2016)
  • Head of Global Epidemiology, H. Lundbeck A/S, Paris, France (2012-2014)
  • Director Real-World Data Investigations, Sanofi Group, Paris, France (2010-2012)
  • Risk Management Plan Officer, Sanofi-Aventis Recherche et Développement, Paris, France (2007-2010)
  • Epidemiology Research Manager, H. Lundbeck A/S, Paris, France (2003-2007)
  • Research Assistant, Hôpital Bichat-Claude Bernard and University of Paris VII, Paris, France (2000-2002)

Education:

Declaration of interests: Patrice Verpillat

Frank Pétavy

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Nationality: French

Career to date:

  • Head of Methodology, European Medicines Agency (2020-present)
  • Head of Biostatistics and Methodology Support, European Medicines Agency (2018-2020)
  • Head of Biostatistics and Methodology Support (ad interim), European Medicines Agency (2016-2018)
  • Work Coordinator, Biostatistics and Methodology Support, European Medicines Agency (2015-2016)
  • Statistician, Scientific Support & Projects, European Medicines Agency (2012-2015)
  • Contract statistician, Amgen Ltd, Uxbridge, UK (2009-2012)
  • Senior statistician, GSK, Greenford, UK (2002-2009)
  • Statistician, GSK, Uxbridge, UK (2001-2002)
  • Statistician, AXESS Ltd, Isleworth, UK (2000-2001)
  • Statistician, IPSEN Pharma, Sant Feliu de Llobregat, Spain (1998-2000)

Education:

Declaration of interests: Frank Petavy

Paolo Alcini

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Nationality: Italian

Career to date:

  • Head of Healthcare Data, European Medicines Agency (2020-present)
  • Head of Data Standardisation and Analytics, European Medicines Agency (2015-2020)
  • Head of Data Collection and Management, European Medicines Agency (2009-2015)
  • 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, 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:

Declaration of interests: Paolo Alcini

Pieter Vankeerberghen

Pieter Vankeerberghen

Nationality: Belgian

Career to date:

  • Head of Clinical Trials Systems, European Medicines Agency (2023-present)
  • Head of Clinical Trials, European Medicines Agency (2020-2023)
  • Head of Division Research and Development, Federal Agency for Medicines and Health Products (FAMHP), Brussels, Belgium (2016-2020)
  • Coordinator Information and Communications Technology (ICT) Projects and Development, Federal Agency for Medicines and Health Products (FAMHP), Brussels, Belgium (2006-2016)
  • Business Process Reengineering Project Leader, Belgian Inspectorate, Brussels, Belgium (2002-2006)
  • Computer Scientist, Belgian Inspectorate, Brussels, Belgium (2000-2002)
  • Human Pharmacology Clinical Trial Manager, Union Chimique Belge (UCB), Brussels, Belgium (1998-2000)
  • Clinical Data Supervisor, Union Chimique Belge (UCB), Brussels, Belgium (1996-1998).
  • Fellowship Assistant, Free University Brussels, Belgium (1988-1996) 
  • Laboratory Technician (Toxicology), University Hospital Brussels, Belgium (1986-1988)

 Education:

Declaration of interests: Pieter Vankeerberghen

Ana Zanoletty Perez

profile photo Ana Zanoletti, EMA's head of clinical trials transformation

Nationality: Spanish

Career to date:

  • Programme manager for Accelerating Clinical Trials in the EU (ACT EU), European Medicines Agency (2022-present)
  • Labeling specialist, European Medicines Agency (2017-2022)
  • Vice-chair of Staff Committee, European Medicines Agency (2019-2021)
  • Procedure manager, European Medicines Agency (2014-2017)
  • Scientific administrator, European Medicines Agency (2006-2014)
  • Pharmacovigilance associate, Eli Lilly and Company, Spain (2004-2006)
  • Clinical Research Coordinator, Eli Lilly and Company, Spain (2003-2004)
  • Clinical Development Associate, Eli Lilly and Company, Spain (2002-2003)
  • Clinical Research Associate, Eli Lilly and Company, Spain (1999-2002

Education:

Regulatory Science and Innovation

Emmanuel Cormier

Nationality: French

Career to date:

  • Scientific Director, Regulatory Affairs – Policy Innovation, Johnson and Johnson MedTech, Leiden, The Netherlands (2022-2023) 
  • Head of Clinical Immunology, Janssen Vaccines and Prevention B.V., Leiden, The Netherlands (2016-2023)
  • Head of Molecular and Bioassays, Janssen Vaccines and Prevention B.V., Leiden, The Netherlands (2013-2016)
  • Associate Director, Clinical Research and Immunology, International AIDS Vaccine Initiative, London, UK (2007-2013)
  • Senior Scientist, Small Molecule Drug Discovery, Progenics Pharmaceuticals, Tarrytown, NY, USA (2002-2007)

Education:

  • Doctor of Philosophy in Molecular Virology, University of Paris VII, France (2002)
  • Master of Sciences in Microbiology and Medical Virology, University of Paris VI, France (1999)
Declaration of Interests: Emmanuel Cormier

Constantinos Ziogas

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Nationality: Greek

Career to date:

  • Head of Small and Medium-sized Enterprise Office, European Medicines Agency (2014-present)
  • Small and Medium-sized Enterprise Office Principal Administrator, European Medicines Agency (2007-2014)
  • Scientific Advice Administrator, European Medicines Agency (1998-2007)
  • Human Medicines Scientific Administrator, European Medicines Agency (1996-1998)
  • Trainee, European Commission Directorate-General for Industry, Brussels, Belgium (1994-1995)

Education:

  • Certificate in Pharmaceutical Medicine, Université Libre de Bruxelles, Belgium (1994)
  • Degree in medicine and surgery, Université Libre de Bruxelles, Belgium (1994)

Declaration of interests: Constantinos Ziogas

Falk Ehmann

Nationality: German 

Picture of Falk Ehmann

Career to date:

  • Head of Innovation and Development Accelerator (ad interim), European Medicines Agency (2023-present)
  • Co-Chair EU Innovation Network, European Medicines Agency (2021-2023)  
  • Chair of the Innovation Task Force, European Medicines Agency (2020-2023)  
  • Head Innovation Task Force, European Medicines Agency, (2015-2020)
  • Scientific Secretariat of the Pharmacogenomics Working Party and Nanomedicines Drafting Group, European Medicines Agency (2010-2015)
  • Product Team Leader in Oncology and Anti-Infectives, European Medicines Agency (2005-2015)  
  • Team and Project Manager, Robert Koch Institute (2002-2004)
  • Lead Researcher, Universitätsklinikum Hamburg Eppendorf (1997-2002)

Education:

  • Medicine, University of Hamburg and Munich
  • Clinical Pharmacology, King’s College London
  • PhD (Cell Signalling Transduction), University of Hamburg, Germany (2002)
  • Master of Science (International and Public Health), Humboldt University of Berlin, Germany
  • Certificates in International and European Law, Humboldt University of Berlin, Germany

Declaration of interests: Falk Ehmann

Ralf Herold

Nationality: German

Career to date:

  • Head of Regulatory Science and Academia (ad interim), European Medicines Agency (2023-present)
  • Senior Scientific Officer, European Medicines Agency (2018-2023)
  • Pediatric Development Leader Regulatory Affairs, Bayer AG, Germany (2017-2018)
  • Senior Scientific Officer, European Medicines Agency (2007-2017)
  • Physician and Research Coordinator, Charité – Universitätsmedizin Berlin (1994-2007)

Education:

  • Specialisation in paediatric and adolescent medicine, Berlin, Germany (2003)
  • Doctor of medicine, Humboldt University, Berlin, Germany (1997)

Declaration of interests: Ralf Herold

Monica Dias

Nationality: Portuguese

Career to date:

  • Head of Supply and Availability of Medicines and Medical Devices, European Medicines Agency (2022-present)
  • Head of Supply and Availability of Medicines and Medical Devices (ad interim), European Medicines Agency (2021-2022)
  • Policy and Crisis Coordinating Officer, European Medicines Agency (2013-2021)
  • Scientific Administrator, Quality of Medicines, European Medicines Agency (2004-2013)
  • Scientific Officer, Disperse Technologies PLC, UK (2000-2004)

Education

  • Doctor of Philosophy, School of Pharmacy and Pharmaceutical Sciences, Cardiff University, UK (2000)
  • Degree in pharmaceutical sciences, Faculdade de Farmácia da Universidade de Lisboa, Portugal (1996)

Declaration of interests: Monica Dias

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