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ICH Info Day Part 2

Track:
ICH Info Day

Day & Time:
April 19, 10:30AM - 12:00PM (Central Europe Standard Time)

Session Number:
S0905

Room Number:
Shanghai 1-2

Type:
Session

Title:
ICH Info Day Part 2

Chair(s):
Agnès Saint-Raymond, MD
Head of International Affairs, Head of Portfolio Board
European Medicines Agency (EMA), United Kingdom

Description:
Part 2 of the ICH Info Day looks at the Efficacy suite of guidelines, in particular the renovation of E6 and E8 GCP guidelines, E17 Multi-regional clinical trials and E9 estimands.

Presentation(s) & Speaker(s):
E8 and E6 Renovation Plan of Action - Putting GCP in the Context of the ‘E Family’
Agnès Saint-Raymond, MD
Head of International Affairs, Head of Portfolio Board
European Medicines Agency (EMA), United Kingdom

E17 Multi-Regional Clinical Trials
Toshiyoshi Tominaga, PhD
Associate Executive Director (for International Programs)
Pharmaceuticals and Medical Devices Agency (PMDA), Japan

E9(R1) Estimands
Robert Hemmings, MS, MSc
Statistics and Pharmacokinetics Unit Manager
Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom