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Testing the Readiness of The Framework: Are The Regulatory Processes Fit for Rapid Development of Treatments and Vaccines?
Session Chair(s)
Florence Roizard, PharmD
Vice President, Regulatory Affairs International
MSD France, France
The COVID 19 pandemic has both shown the agility, value and strength of medicines developers as the treatments and vaccines are developed at a speed unseen before. There are a number of learnings from the activities and pilots that have been conducted to accelerate the development, assessment and authorization, both for novel and established medicines. The session will give the floor to key NCA leaders to talk about their experiences in leading these activities and will equally bring in the view from a medicines developer from their experiences in developing 10-fold faster than usual. The presenters will propose which learnings should be carried over to post-pandemic regulatory and development systems in Europe.
Learning Objective : To discuss developers perspective on developing treatments and vaccines addressing emerging health threats To learn about case studies on repurposing and joint scientific advice leveraged in response to Covid-19 challenges To hear from the ethics committee perspective how the framework should evolve
Speaker(s)
Benefits of Repurposing: Finding Treatments Rapidly for COVID-19
Cesar Hernandez Garcia
Spanish Agency For Medicines and Medical Devices, Spain
Head of Department, Department of Medicines for Human Use
Simultaneous National Scientific Advice for COVID Treatments and Vaccines: Feeding Forward
Bettina Ziegele, MA
Division Major Policy Issues, Paul-Ehrlich-Institut, Germany
Chair DG SNSA of the EU-Innovation Network at EMA & Liaison Officer,
How to make the combined ecosystem more successful and efficient in developing therapeutics to tackle a global health threat - industry perspectives
Sean Curtis, MD, MPH
MSD, United States
Senior Vice President, Global Regulatory Affairs and Clinical Safety
Ethics Committee Perspectives: How the Current and Future EU Clinical Trial Regulatory Frameworks Can Contribute to the Rapid Development of COVID Treatments and Vaccines
Karen Kiilerich
The National Committee on Health Research Ethics , Denmark
Special Legal Consultant
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