2nd European Stakeholder Workshop

The 2nd European Stakeholder Workshop of STARS was a virtual event on 17-18 November 2021. Under the headline "Towards a Common Strategy to Empower Academia in Regulatory Awareness and Knowledge", the workshop followed up on the discussions on how to improve strategies for the regulatory support to academia, and bridge the translational gap of academic-driven health research.

Agenda and Presentations

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DAY ONE, 17 November 2021

**BLOCK ONE**
Time		Session
10:00 - 10:30		Welcome and introductions Chair: Wiebke Löbker (BfArM, STARS Coordination) Emer Cooke Executive Director, European Medicines Agency (EMA) Alexandru Padurean Project Officer, Health and Digital Executive Agency (HaDEA) Karl Broich President BfArM and Chairperson of The Heads of Medicines Agencies (HMA) Management Group
10:30 - 11:15		CSA STARS: The road so far – Update / spotlight on project activities and results STARS Coordination (Wiebke Löbker and Anne Heß, BfArM, STARS Coordination)
11:15 - 12:00		Aim and Background of the Workshop – setting the stage STARS Coordination (Wiebke Löbker and Anne Heß, BfArM, STARS Coordination)
12:00 - 13:15		Lunch break

**BLOCK TWO**
Time		Session
13:15 - 14:15		Panel Discussion on STARS Recommendations from the Common Strategy draft Moderated by Peter Mol (MEB, STARS partner) Needs from the perspective of Academic Pharma Teun van Gelder (Leiden University) Status, Challenges and Opportunities for Regulatory Advice for Academia – regulatory perspective Nils Lilienthal (BfArM) How can Industry help to bridge the regulatory knowledge gap? Maren von Fritschen (addonpharma, EUCOPE representative) Recommendations for academic investigators and academic sponsors Sabine Klager (ECRIN) Recommendations from the funder perspective Delphie Coppens (Dutch Cancer Society)
14:15 - 14:30		Short break
14:30 - open end (around 16:30)		4 Breakout Sessions with polls (max. 25-30 participants per group) to discuss the recommendations of the Common Strategy draft and the strategic recommendations developed by STARS Breakout Session are moderated by STARS partners (Laurence O’Dwyer (HPRA), Viktoriia Starokozhko (MEB), Wiebke Löbker (BfArM), Juan Garcia Burgos (EMA) Rapporteur: stakeholders (tbd) Note-Takers: STARS members
		End of Day One

DAY TWO, 18 November 2021

**BLOCK THREE**
Time		Session
10:00 - 13:00 with short break in between		Presentation of results and polls from breakout session by rapporteurs of each breakout session Speaker: Rapporteurs Report Break Out Session A Report Break Out Session B Report Break Out Session C Report Break Out Session D Plenary discussion on recommendations in the Common Strategy Wolfgang Ballensiefen (DLR-PT, STARS partner) Summary, conclusion and outlook by STARS coordination Moderated by Wiebke Löbker (BfArM, STARS coordination)
		End of workshop