Executive Director

Biography

Emer Cooke began her mandate as Executive Director of EMA on 16 November 2020.

Ms Emer Cooke has over 30 years of experience in international regulatory affairs, with more than 18 of these in leadership roles. Before taking up her current role, she was the Director responsible for all medical product related regulatory activities at the World Health Organization (WHO) in Geneva between November 2016 and November 2020.

Ms Cooke worked at EMA between 2002 and 2016. She joined the Agency as Head of Inspections and became Head of International Affairs in 2009.

ema's executive director emer cooke eu flags — Ms Emer Cooke. Photo: EMA

Prior to that, she was Principal Administrator in the Pharmaceuticals Unit of the European Commission between 1998 and 2002, with responsibility for inter alia, inspections, international activities including enlargement of the EU and selected legislative initiatives.

Ms Cooke worked for the European Federation of Pharmaceutical industries and Associations (EFPIA) as Manager of Scientific and Regulatory Affairs from 1992 to 1995 and part time from 1996 to 1998. She also worked part time as an independent pharmaceutical policy advisor, based in the Czech Republic, from 1996 to 1998. Ms. Cooke held a number of roles within the Irish pharmaceutical sector between 1985 and 1990 including two years as a pharmaceutical assessor at the Irish medicines regulatory authority.

Ms. Cooke holds a degree in pharmacy and two master’s degrees in science and in business administration from Trinity College Dublin, Ireland. She is an Irish national.

Career to date

Executive Director, European Medicines Agency, Amsterdam, Netherlands (2020–present)
Director responsible for all medical product-related regulatory activities at the World Health Organization (WHO), Geneva, Switzerland (2016-2020)
Responsible for International Affairs at the European Medicines Agency (EMA), London, UK (2009–2016)
Head of Inspections at the European Medicines Agency (EMA), London, UK (2002–2009)
Principal Administrator in the Pharmaceuticals Unit of the European Commission, Brussels, Belgium (1998–2002)
Independent pharmaceutical policy advisor, Prague, Czech Republic (1996–1998 part-time)
Manager of Scientific and Regulatory Affairs at the European Federation of Pharmaceutical industries and Associations (EFPIA), Brussels, Belgium (1992–1995; 1996–1998 part-time)
Regulatory Affairs Manager at Chanelle Pharmaceuticals, Loughrea, Galway, Ireland (3 month assignment - 1991)
Pharmaceutical assessor at the Irish medicines regulatory authority, Health Products Regulatory Agency (HPRA), Dublin, Ireland (1988–1990)
Pharmaceutical Development Manager at Intercon Pharma Limited, Dublin, Ireland (1987 – 1988)
Registration Pharmacist at Mary Purcell Ltd, Dublin, Ireland (1986 – 1987)
Community Pharmacist at ODC Chemists Limited, Dublin Ireland (1985–1986)

Declaration of interests

Education

Master's degree in Business Administration, Trinity College Dublin, Ireland (1991)
Master of Science, Trinity College Dublin, Ireland (1985)
Bachelor in Science (Pharmacy), Trinity College Dublin, Ireland (1982)

Membership of professional organisations

Member of the Pharmaceutical Society of Ireland since 1995
Board Member of the Uppsala Monitoring Centre Board, November 2016 to November 2020
Board Member of the Trinity College Dublin School of Pharmacy Advisory Board, March 2015 to November 2016
Observer to the Trinity College Dublin School of Pharmacy Advisory Board, November 2016 to November 2020
Member of the Expert Advisory Group for the Medicines Patent Pool, July 2019 to November 2020
Member of TOPRA Advisory Council, June 2020 to November 2020

Office of the Executive Director

The Office of the Executive Director supports the Executive Director in the effective management and functioning of the Agency.

Anabela Marcal

Nationality: Portuguese

Career to date:

Adviser to the Executive Director, European Medicines Agency (2025-present)
EMA Liaison Official to the US FDA, European Medicines Agency (2020-2025)
Head of Clinical Trials Workstream, European Medicines Agency (2020)
Head of Committees and Inspections Department, European Medicines Agency (2013-2020)
Section Head Community Procedures, European Medicines Agency (2009-2013)
Specialised Group Leader CNS/Endocrinology, Post-Authorisation Safety and Efficacy of Medicines, European Medicines Agency (2001-2009)
Scientific Administrator in Pharmacovigilance, European Medicines Agency (1999-2001)
Scientific Administrator, National Pharmacovigilance Centre, Portuguese National Authority of Medicines and Health Products – INFARMED (1995-1998)
Health Assistant, Hospital Pharmacy, Hospital Dona Estefânia, Lisbon, Portugal (1991-1995)

Education:

Professional certification in Hospital Pharmacy, Portugal (1994)
Degree in Pharmacy, University of Lisbon, Portugal (1991)

Previous Executive Directors

Guido Rasi (2011 - 2014 and 2015 - 2020)
Thomas Lönngren (2001 – 2010)
Fernand Sauer (1994 - 2000)