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Taking Stock on Parallel Consultation & Early Access Developments
Session Chair(s)
Michael Berntgen, PhD
Head of Scientific Evidence Generation
European Medicines Agency, Netherlands
Regulators, HTA and Industry participants address information gaps on rationale, experience and frameworks for regulatory and HTA advice on post-licensing/launch evidence generation (PLEG) and challenges posed by conditional marketing authorisation.
Speaker(s)
PLEG: The Perspective of Pharmaceutical Developers
Solange Corriol-Rohou, DrMed, MD, PhD
AstraZeneca , France
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
Health Technology Assessment advice on Post-Launch Evidence Generation
Chantal Guilhaume
Haute Autorité De Santé (HAS), France
Scientific Project Manager
A Regulator's view on PLEG
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
Panelist
Flora Giorgio, MPharm
European Commission, Belgium
Deputy Head of Unit Medical Devices, DG SANTE – Medical Products and Innovation
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