Steffen Thirstrup has been appointed as Chief Medical Officer of EMA. In this role, he will provide scientific leadership across EMA and its scientific committees to reinforce the Agency’s capacity to respond to public health challenges and emergencies, and shape EMA’s contribution to EU-health initiatives such as the fight against antimicrobial resistance or Europe’s Beating Cancer Plan. He will also be EMA’s “medical voice” with external stakeholders and explain the considerations that underpin EMA’s regulatory decisions on the benefits and risks of medicinal products.
Prof. Steffen Thirstrup is a medical doctor with a PhD in pharmacology and broad clinical experience in general internal medicine. He has a track record of working with the EU regulatory network. He previously led the Division for Medicines Assessment and Clinical Trials at the Danish Health and Medicines Authority and was the Danish member of EMA’s human medicines committee (CHMP). He was also a member of EMA’s Committee for Advanced Therapies (CAT), the Chairperson of the CHMP’s Respiratory Drafting Group and Co-Chair of the European Commission Working Group on Market Access of Biosimilars.
Prof. Thirstrup is Affiliate Professor at the University of Copenhagen and has worked across a broad range of therapeutic areas throughout different stages of medicine development. Before joining EMA, Prof. Thirstrup worked at the pharmaceutical consultancy company NDA Group, first as a medical advisor and from April 2014 as a board director.
Scientific Data Works: Using Science to Navigate the Global Regulatory Maze
You’re developing an FDA- and/or EMA-regulated drug, biologic, or medical device. Throughout the drug development process, your goal is to get to the next regulatory milestone in the most expeditious...