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Optimising Paediatric Drug Development in the EU
Session Chair(s)
Karl-Heinz Huemer, MD, PhD
Clinical Assessor, Scientific Office
Austrian Medicines and Medical Devices Agency (AGES), Austria
This session is a follow-up to Session 0101 - Optimising Orphan Drug Development in the EU. Different stakeholders will be brought together to discuss how they can contribute to better and more efficient paediatric drug development in Europe. From the current regulatory framework to ways drug developers approach such R&D, speakers will provide different perspectives on the experience so far and how Europe can be an important region to bring innovative treatments to children. A follow-up panel will include paediatric and orphan perspectives from both sessions. efficient paediatric drug development in Europe. From the current regulatory framework to ways drug developers approach such R&D, speakers will provide different perspectives on the experience so far and how Europe can be an important region to bring innovative treatments to children. A follow-up panel will include paediatric and orphan perspectives from both sessions.
Speaker(s)
Panel Discussion
Geneviève Le Visage, PharmD, MSc
Novartis Pharma AG, Switzerland
Head EU RA Policy and Liaison
Panel Discussion
Camilla Nawrocki, MPharm
Zealand Pharma A/S, Denmark
Senior Regulatory Project Manager
Panel Discussion
Dimitrios Athanasiou, MBA
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece
Patient Advocate
Panel Discussion
Sandra Kweder, MD
Greenleaf Health/Elilquent, United States
Principal, Drug and Biological Products
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