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ICH Info Day Part 1
Session Chair(s)
Petra Doerr, PharmD, RPh
Director
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
Part 1 of the ICH Info Day (Session 1004) has two sections; the first examines the way the ‘new ICH’ operates, and second looks at how ICH selects new topics for harmonisation as well as an overview some key guidelines. Part 2 of the ICH Info Day (Session 0905) focuses on the Efficacy suite of guidelines, in particular the renovation of E6 and E8 GCP guidelines, E17 Multi-regional clinical trials and E9 estimands.
Speaker(s)
The New Role of IFPMA in ICH
Sarah Adam
IFPMA, Switzerland
Associate Director, Regulatory Affairs
Has the ICH Reform been a Success?
Lenita Lindström, LLM
European Commission, Belgium
ICH Assembly Chair and Senior Expert, European Commission
Petra Doerr, PharmD, RPh
European Directorate for the Quality of Medicines and Healthcare (EDQM), France
Director
E19 Optimising Safety Data Collection
Peter Mol, PharmD, PhD
MEB, Netherlands
CHMP member, NL
E11 Paediatric Guideline Suite
Solange Corriol-Rohou, DrMed, MD, PhD
AstraZeneca , France
Senior Director, Global Regulatory Affairs & Policy, R&D, Europe
Panel Discussion
Dawn Ronan
ICH Secretariat, Switzerland
Regulatory & Scientific Manager
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