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Wednesday, February 6 • 10:45 - 11:45
#S0101: Optimising Orphan Drug Development in the EU

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Component Type: Session

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.


Bruno Sepodes, PharmD, PhD, MSc


Panel Discussion
Violeta Stoyanova, MD, PhD, MPH

Panel Discussion
Martine Zimmermann, PharmD

Panel Discussion
Sandra L. Kweder, MD

Panel Discussion
François Houyez

avatar for François Houyez

François Houyez

Information and Access Director, Health Policy Advisor, European Organisation for Rare Diseases (EURODIS), France
François Houÿez is working at the European Organisation for Rare Diseases EURORDIS where he is Director of Treatment Information and Access, Policy Advisor. He has always been working as a patient advocate since the early 90s, first in the HIV/AIDS advocacy, and in rare diseases... Read More →
avatar for Sandra Kweder

Sandra Kweder

Deputy Director, Europe Office, Office of Global Programs and Strategies, FDA, FDA, United States
Sandra L. Kweder, MD, is Deputy Director of the Europe Office in the FDA. She is posted in Amsterdam, working alongside colleagues in the European Medicines Agency (EMA) to oversee a large portfolio of regulatory science working partnerships and collaborations that include experts... Read More →
avatar for Bruno Sepodes

Bruno Sepodes

Vice Chair CHMP; Member COMP; Professor of Pharmacology and Pharmacotherapy, University of Lisbon
Bruno Sepodes is a Professor of Pharmacology and Pharmacotherapy at the Faculty of Pharmacy of the University of Lisbon (Portugal). Besides being Senior non-clinical expert for INFARMED (Portuguese National Authority for Medicines and Health Products), he became a member of the European... Read More →
avatar for Violeta Stoyanova

Violeta Stoyanova

Chair COMP EMA, Chair Scientific and Regulatory Advice MEB, Medicines Evaluation Board
Dr. Stoyanova-Beninska is Chair of the Committee for Orphan Medicinal Products at the European Medicines Agency since September 2018. In the previous 6 years she has been the member from the Netherlands at the COMP. She is also additional expert in the CNS working party and was previously... Read More →
avatar for Martine Zimmermann

Martine Zimmermann

Senior Vice President, Head of Global Regulatory Affairs, R&D and Commercial Qua, Alexion, Astrazeneca Rare Disease, Switzerland
Martine Zimmermann is Senior Vice President and Head of Regulatory Affairs, R&D & Commercial Quality at Alexion, AstraZeneca Rare Disease. Dr Zimmermann has over 25 years of combined R&D and global regulatory strategy experience. She joined Alexion in 2009 and has since then been... Read More →

Wednesday February 6, 2019 10:45 - 11:45 CET
E1 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  01 Stakeholders and Regulatory System Optimisation, Session
  • Featured Topics Regulatory Science
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