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Austria Center Vienna

2019年2月05日 (火) 午前 7:00 - 2019年2月07日 (木) 午後 5:00

Bruno-Kreisky-Platz 1, 1220 Vienna, Austria

DIA EUROPE 2019

Optimising Paediatric Drug Development in the EU

Session Chair(s)

Karl-Heinz  Huemer, MD, PHD

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)

Geneviève  Le Visage, PHARMD, MSC

Panel Discussion

Geneviève Le Visage, PHARMD, MSC

Novartis Pharma AG, Switzerland

Head EU RA Policy and Liaison

Camilla  Nawrocki, MPHARM

Panel Discussion

Camilla Nawrocki, MPHARM

Zealand Pharma A/S, Denmark

Senior Regulatory Project Manager

Dimitrios  Athanasiou, MBA

Panel Discussion

Dimitrios Athanasiou, MBA

WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece

Patient Advocate

Sandra  Kweder, MD

Panel Discussion

Sandra Kweder, MD

ELIQUENT Life Sciences, United States

Principal, Drug and Biological Products

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