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Session 1 DOES THE REGULATION DELIVER ON ITS GOAL OF IMPROVING AVAILABILITY OF NEW MEDICINES TO PAEDIATRIC PATIENTS IN EUROPE?
Session Chair(s)
Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
AstraZeneca , France
Setting the scene…With 10 years of paediatric regulation, hundreds of agreed Paediatric Investigation Plans and a growing number of ongoing paediatric clinical trials one question has still to be answered: will all these efforts also lead to increased availability of new medicines to patients and prescribers in Europe? What has been achieved during these period as a result of the Regulation? The session will give an overview on the state of the play from the different stakeholders involved.
Speaker(s)
A Regulator’s View
Michael Berntgen, PhD
European Medicines Agency, Netherlands
Head of Scientific Evidence Generation
An Academia/Prescriber’s View
Gilles Vassal, MD, PhD
Institute Gustave Roussy, France
Head of Clinical Research Division
An Industry View
Bruno Flamion, MD, PhD
Idorsia Pharmaceuticals Ltd, Switzerland
VP, Head Strategic Development
A Patient’s View
Dimitrios Athanasiou, MBA
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece
Patient Advocate