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Comparing Apples with Oranges: How EU and US Expedited Regulatory Pathways Differ in Practice - Learnings, Reflections and Future Trends
Session Chair(s)
Nadia Assenova, LLM, MBA, MPharm, MS
Moderna Switzerland Gmbh, Switzerland
Tiia Metiäinen, MPharm
Specialist, Regulatory Science & Advocacy
Lundbeck, Denmark
This session will compare recent hands-on experience with expedited regulatory pathways in EU and US (e.g. PRIME, Breakthrough Designation and beyond) both from the regulators’ and sponsor’s viewpoint. It will also include broader stakeholders’ perspectives on the present and future of these regulatory tools. A panel debate will be structured around statements that both panelists and the audience will be able to vote upon with the aim of inspiring honest discussion on the real benefits, drawbacks and future opportunities of these regulatory tools in the EU, US and globally.
Speaker(s)
Case Study: Recent Experience with US Breakthrough and EU PRIME Designations – Reflections and Learnings from the Applicant’s Perspective
Carol Pitcher-Towner, PhD
Alnylam Pharmaceuticals, United Kingdom
VP, EU Regulatory Affairs
Health Authority Perspectives on Expedited Pathways: Reflection on Experience to Date, Stakeholder Collaboration and Future Trends
Sandra Kweder, MD
Greenleaf Health/Elilquent, United States
Principal, Drug and Biological Products
Experience and Reflections on PRIME from CHMP Perspective– Most Common Challenges, Opportunities for Stakeholder Collaboration and Possible Future Evolution of the Programme
Milena Stain, MD
BASG, Austria
AT CHMP Alternate Member
Panel Discussion
Murray M. Lumpkin, DrMed, MD, MSc
Bill and Melinda Gates Foundation, United States
Deputy Director, Integrated Development, Lead for Global Reg Systems Initiative
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