14th EUFEPS Talks

We want to invite you to the 14th EUFEPS Talks on December 11, 2023 at 4 pm CET.

Steffen Thirstrup will give a talk with the title: "The changing landscape of medicines regulation in EU".

Abstract:

The regulatory landscape of EU is undergoing major changes in the coming years. Learnings from the COVID-19 pandemic have resulted in EMA been given an extended mandate to deal with shortages, and a new regulation on HTA assessment is under implementation coming into force by January 2025. In addition to these challenges the European Commission has prosed a major revision of the general pharmaceutical legislation. Although this legislation is currently undergoing tripartite discussions in Brussels the proposal offers a lot of opportunities to improvements of the Agency’s modus operandi as well as public health in EU. In this EUFEPS talk Steffen Thirstrup, the Chief Medical Officer of the EMA will address some of these challenges and opportunities from his perspective.

CV:

Steffen Thirstrup is a medical doctor and board-certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine with special emphasis on adult respiratory medicine. Additionally, Dr. Thirstrup was appointed adjunct professor in pharmacotherapy at the Faculty of Health Sciences, University of Copenhagen, in 2012.
From 2004-09 Steffen Thirstrup worked at Danish Medicines Agency first as the Danish member of CHMP at the European Medicines Agency (EMA) for five years including 10 months as joint CHMP- and CAT-member, followed by a short period as head of Danish Institute for Rational Pharmacotherapy dealing with HTA and best practice guidelines for primary care. In 2011 Prof. Thirstrup rejoined the licensing division at the Danish Medicines Agency acting as Head of Division for Medicines Assessment and Clinical Trials. During this period Prof Thirstrup co-chaired the European Commission’s working group on market access for biosimilars medicinal products and acted as key scientific contact for the managing entity of the IMI beneficiaries for the PROTECT collaboration (Pharmacoepidemiological Research on Outcomes of Therapeutics by a European ConsorTium).
In March 2013, Prof Thirstrup joined the pharmaceutical consultancy company NDA Group AB as a full-time medical advisor on NDA’s regulatory advisory board. In April 2014 Prof Thirstrup was appointed as director for the Regulatory Advisory Board at NDA Regulatory Services Ltd.
Since June 2022 Prof Thirstrup has been the Chief Medical Officer at the European Medicines Agency, Amsterdam, The Netherlands
Prof Thirstrup is author of more than 30 scientific papers, guidelines and text-book chapters as well as co-editor of 5th edition of Basal og Klinisk Farmakologi (Medical school pharmacology textbook in Danish).
Prof Thirstrup shares his life between Amsterdam and with his family in a small community (Værløse) just outside Copenhagen, Denmark

Registration:

A registration is needed for this event. Please use the following link: https://us06web.zoom.us/meeting/register/tZMofu-uqTgqHtZO921bzjWQkM_enKjjakxI. After the registration you will receive an E-Mail with the log-in details.