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Congress Center Basel

Apr 17, 2018 2:00 PM - Apr 19, 2018 11:00 PM

Messeplatz 21 , CH-4021 Basel , SWITZERLAND

DIA EUROPE 2018

ICH Info Day Part 1

Session Chair(s)

Petra  Doerr, PharmD, RPh

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)

Sarah  Adam

The New Role of IFPMA in ICH

Sarah Adam

IFPMA, Switzerland

Associate Director, Regulatory Affairs

Lenita  Lindström, LLM

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

Petra Doerr, PharmD, RPh

European Directorate for the Quality of Medicines and Healthcare (EDQM), France

Director

Peter  Mol, PharmD, PhD

E19 Optimising Safety Data Collection

Peter Mol, PharmD, PhD

MEB, Netherlands

CHMP member, NL

Solange  Corriol-Rohou, DrMed, MD, PhD

E11 Paediatric Guideline Suite

Solange Corriol-Rohou, DrMed, MD, PhD

AstraZeneca , France

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe

Dawn  Ronan

Panel Discussion

Dawn Ronan

ICH Secretariat, Switzerland

Regulatory & Scientific Manager

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