With multiple COVID-19 vaccines approaching the finish line, and dozens of COVID-19 drugs in development, more eyes are on the European Medicines Agency (EMA)’s decisions than ever before. Emer Cooke, who started as Executive Director of the EMA in November, is ready. Cooke, a pharmacist by training, has more than 30 years’ experience in pharmaceutical regulation. During this time, she has seen the system transform: the typewriters and carbon copy are gone, replaced by unprecedented volumes of data and complexity. With prior roles that have included oversight of the regulation of medical products at the World Health Organization, Head of Inspections at the EMA and Head of International Affairs at the EMA, she is prepared for the multidisciplinary nature of the challenges ahead. She spoke with Asher Mullard about the speed of progress with COVID-19 vaccines, the potential longer-term impacts of the pandemic on regulatory affairs and her goals for the EMA once the world returns to business as usual.
