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Learnings from the First 10 years of the Paediatric Regulation –Back to Inform on the Future?
Session Chair(s)
Simon Bennett, MSC
Director, EU Regulatory Policy
Biogen, United Kingdom
In late 2017, the EC finalised their report on 10-years of experience with the Paediatric Regulation, which included a positive agenda of actions that may lead to enhanced efficiency in the development and implementation of paediatric investigation plans. This session provides the opportunity to hear directly from the European Commission about the recommendations in their report and the rationale behind them. The session will also include contributions from other key stakeholders, including industry and academia, who will present their views on the opportunities presented within the EC report to improve the current implementation of the paediatric regulation.
Speaker(s)
View from the European Commission
Florian Schmidt, JD, LLM
DG SANTE, European Commission, Belgium
Deputy Head of Unit B5 – Medicines: Policy, Authorisation and Monitoring
View from Academia
Mark Turner, MD, PHD, MRCP, FFPM
University of Liverpool, United Kingdom
Chief Executive Officer of the c4c- Stichting (c4c-S) & Professor of Neonatology
View from Industry
Heidrun Hildebrand
BAYER, Germany
Paediatric Development Alliance Manager, Paediatric Medicine; Research and De