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ICH Info Day Part 1

Track:
ICH Info Day

Day & Time:
April 19, 8:30AM - 10:00AM (Central Europe Standard Time)

Session Number:
S1004

Room Number:
Shanghai 1-2

Type:
Session

Title:
ICH Info Day Part 1

Chair(s):
Petra Doerr, PharmD, PhD, RPh
Deputy Executive Director
Swissmedic, Switzerland

Description:
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.

Presentation(s) & Speaker(s):
The New Role of IFPMA in ICH
Sarah Adam, PhD, MSc
Manager Regulatory Affairs
IFPMA, Switzerland

Has the ICH Reform been a Success?
Lenita Lindström-Gommers, LLM
ICH Assembly Chair and Senior Expert, European Commission
European Commission, Belgium

Overview of Current Work in Guideline Development and New Topics Selection?
Petra Doerr, PharmD, PhD, RPh
Deputy Executive Director
Swissmedic, Switzerland

E19 Optimising Safety Data Collection
Peter Mol, PhD, RPh
Principal Clinical Assessor
College ter Beoordeling van Geneesmiddelen - Groningen, Netherlands

E11 Paediatric Guideline Suite
Solange Corriol-Rohou, DrMed, MD, PhD
Senior Director, Global Regulatory Affairs & Policy, Europe
AstraZeneca Global Medicines Development, France

Panel Discussion
Dawn Ronan
Regulatory & Scientific Manager
ICH Secretariat, Switzerland