Emer Cooke The European Medicines Agency

Emer Cooke has been the Executive Director of the European Medicines Agency, based in Amsterdam, since November 2020. She also holds the role of Chair of the International Coalition of Medicines Regulatory Authorities (ICMRA).

Between November 2016 and November 2020, she was the Director responsible for all medical product related regulatory activities at the World Health Organization in Geneva.

Ms. Cooke is a pharmacist with Master’s degrees in Science and Business Administration from Trinity College Dublin. She has over 30 years’ experience in international regulatory affairs and held management positions at the EMA as Head of Inspections and Head of International Affairs respectively from 2002 until 2016.

She has also worked in the Pharmaceuticals unit of the European Commission, where intra-alia, she was responsible for international collaboration, EU enlargement and the orphan medicines regulation for the European Pharmaceutical Industry Association (EFPIA) and in various industry and regulatory positions in Ireland.

In 2021 she received the Muckross (her alma mater) Woman of the Year award. In 2022 she received European Movement Ireland’s “European of the Year” award. In 2023 she was awarded an honorary doctorate by the Royal College of Surgeons Ireland (RCSI) University of Medicines and Health Sciences.

She has also worked in the Pharmaceuticals unit of the European Commission, where intra-alia, she was responsible for international collaboration, EU enlargement and the orphan medicines regulation for the European Pharmaceutical Industry Association (EFPIA) and in various industry and regulatory positions in Ireland.

In 2021 she received the Muckross (her alma mater) Woman of the Year award. In 2022 she received European Movement Ireland’s “European of the Year” award. In 2023 she was awarded an honorary doctorate by the Royal College of Surgeons Ireland (RCSI) University of Medicines and Health Sciences.

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