An interview with Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA).
Steffen Thirstrup, chief medical officer, European Medicines Agency (EMA) was interviewed by Chris Spivey, editorial director, Pharmaceutical Technology® and Biopharmaceutical International®, on Jan. 25, 2024 for the Europa Perspectives series. Thirstrup talks about major recent or ongoing challenges EMA is facing, such as drug shortages, COVID-19, Brexit, and ensuring sufficient skilled staff availability, alongside the solutions being implements to overcome them.
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.
FDA Reopens Comment Period on HCP Immunogenicity Risk of Follow-on Recombinant Peptides
January 2nd 2025FDA is reopening the comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, until March 3, 2025.