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Optimising Orphan Drug Development in the EU
Session Chair(s)
Bruno Sepodes, PharmD, PhD, MPH, MSc
Vice-Chair CHMP (EMA); Senior Expert INFARMED
INFARMED, Portugal
Following an unprecedented decade of change for rare diseases and orphan drugs, it's time to think about the future and make sure the most meaningful times of change are about to start. The session will focus on the much needed stakeholder engagement and explore the regulatory and scientific trends in the field and is the first part of a series on orphan and paediatric drug development in the EU.
Speaker(s)
Panel Discussion
Violeta Stoyanova-Beninska, MD, PhD, MPH
Medicines Evaluation Board, Netherlands
Chair COMP EMA, Chair Scientific and Regulatory Advice MEB
Panel Discussion
Martine Zimmermann, PharmD
Ipsen , France
Senior Vice President, Head of Global Regulatory Affairs
Panel Discussion
Sandra Kweder, MD
ELIQUENT Life Sciences, United States
Principal, Drug and Biological Products
Panel Discussion
François Houyez
European Organisation for Rare Diseases (EURORDIS), France
Treatment Information and Access Director, Health Policy Advisor
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