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DIA Europe 2019 has ended
Thursday, February 7 • 12:00 - 13:15
#S0107: Comparing Apples with Oranges: How EU and US Expedited Regulatory Pathways Differ in Practice - Learnings, Reflections and Future Trends

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Component Type: Session

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.

Chair

Tiia Metiäinen, MPharm
Nadia Assenova, MBA, MPharm, MS

Speaker

Case Study: Recent Experience with US Breakthrough and EU PRIME Designations – Reflections and Learnings from the Applicant’s Perspective
Carol Pitcher-Towner, PhD

Health Authority Perspectives on Expedited Pathways: Reflection on Experience to Date, Stakeholder Collaboration and Future Trends
Sandra L. Kweder, MD

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

Panel Discussion
Murray M. Lumpkin, DIAFellow, MD, MSc



Speakers
avatar for Nadia Assenova

Nadia Assenova

Head Regulatory Affairs Europe, Sage Therapeutics
Nadia Assenova MPharm, MBA, MSc is Head of Regulatory Affairs Europe at Sage Pharmaceuticals GmbH. She has more than 15 years of global regulatory strategy experience spanning across a variety of therapeutic areas and development stages. Nadia started her career at Novartis Pharma... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Liaison to the EMA, Office of International Programs, OC, FDA
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA Office of International Programs. Dr. Kweder previously served for more than a decade as Deputy Director, Office of New Drugs, in FDA’s Center for Drug Evaluation & Research, where she actively led numerous... Read More →
avatar for Murray Lumpkin

Murray Lumpkin

Deputy Director, Regulatory Affairs, Lead Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation
Murray M. Lumpkin, MD, serves as Deputy Director, Integrated Development, and Lead for Global Regulatory Systems Initiatives, for The Bill & Melinda Gates Foundation, working to improve the efficiency and effectiveness of regulatory processes in low- and middle-income countries. He... Read More →
avatar for Tiia Metiäinen

Tiia Metiäinen

Specialist, Regulatory Science & Advocacy, Lundbeck
Tiia Metiäinen is currently working as Specialist, Regulatory Science and Advocacy at Lundbeck headquarters in Copenhagen, focusing on regulatory policy and intelligence from a global development angle. H. Lundbeck A/S is a global pharmaceutical company specialized in psychiatric... Read More →
CP

Carol Pitcher-Towner

VP, EU Regulatory Affairs, Alnylam Pharmaceuticals
Carol Pitcher-Towner is Head of International Regulatory Affairs at Alnylam. Alnylam is leading the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of patients who have limited or inadequate treatment... Read More →
avatar for Milena Stain

Milena Stain

AT CHMP Alternate Member, BASG
Milena Stain joined the Austrian Federal Office for Safety in Health Care in 2006. She is working in the Scientific Office, which focusses on centralised European procedures during drug development, marketing authorisation and life-cycle management. Since 2009 she is the Austrian... Read More →


Thursday February 7, 2019 12:00 - 13:15
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  • Featured Topics Regulatory Science
  • Tags Session