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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
Associate Director, Regulatory Affairs, IFPMA, Switzerland
Has the ICH Reform been a Success?
Lenita Lindström, LLM
ICH Assembly Chair and Senior Expert, European Commission, European Commission, Belgium
Petra Doerr, PharmD, RPh
Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), France
E19 Optimising Safety Data Collection
Peter Mol, PharmD, PhD
CHMP member, NL, MEB, Netherlands
E11 Paediatric Guideline Suite
Solange Corriol-Rohou, DrMed, MD, PhD
, SCR Consulting, France
Panel Discussion
Dawn Ronan
Regulatory & Scientific Manager, ICH Secretariat, Switzerland
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