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Learnings from the First 10 years of the Paediatric Regulation –Back to Inform on the Future?

Hot Topic/Stand Alone

Day & Time:
April 18, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:

Room Number:


Learnings from the First 10 years of the Paediatric Regulation –Back to Inform on the Future?

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.

Presentation(s) & Speaker(s):
View from the European Commission
Florian Schmidt, JD, LLM
Deputy Head of Unit B5 – Medicines: Policy, Authorisation and Monitoring
DG SANTE, European Commission, Belgium

View from Academia
Mark Turner, PhD, MRCP
Senior Lecturer in Neonatology; Co-Director
International Neonatal Consortium, United Kingdom

View from Industry
Heidrun Hildebrand
Global Program Head, TA Pediatric Development
Bayer AG, Germany