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Optimising Orphan Drug Development in the EU

Session Chair(s)

Bruno  Sepodes, PharmD, PhD, MSc

Bruno Sepodes, PharmD, PhD, MSc

  • Vice Chair CHMP; Member COMP; Professor of Pharmacology and Pharmacotherapy
  • University of Lisbon , 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.


Violeta  Stoyanova, MD, PhD, MPH

Panel Discussion

Violeta Stoyanova, MD, PhD, MPH

  • Chair COMP EMA, Chair Scientific and Regulatory Advice MEB
  • Medicines Evaluation Board, Netherlands
Martine  Zimmermann, PharmD

Panel Discussion

Martine Zimmermann, PharmD

  • Senior Vice President, Head of Global Regulatory Affairs
  • Alexion Pharma International Sàrl, Switzerland
Sandra L. Kweder, DrMed, MD

Panel Discussion

Sandra L. Kweder, DrMed, MD

  • Deputy Director, Liaison to the EMA, Office of International Programs, OC
  • FDA, United States
François  Houyez

Panel Discussion

François Houyez

  • Treatment Information and Access Director, Health Policy Advisor
  • European Organisation for Rare Diseases (EURODIS), France