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Radisson Blu

2019年11月25日 (月) 午前 9:00 - 2019年11月26日 (火) 午後 5:30

Steinentorstrasse 25, 4001 Basel, Switzerland

Advancing CMC Workshop

Accelerated pathways, EU CMC trends and global opportunities

Session 7: Reliance Programmes

Session Chair(s)

Frank  Montgomery, PHD

Frank Montgomery, PHD

Global Head Regulatory CMC, GRAPSQA

AstraZeneca, United Kingdom

Susanne  Ausborn, PHD

Susanne Ausborn, PHD

Global Head International Regulatory Policy

Roche, Switzerland

Session 7: Reliance Programmes

Speaker(s)

Rebecca  Lumsden, PHD

Overview of the Reliance Programmes Available Globally

Rebecca Lumsden, PHD

Sanofi, United Kingdom

Head of Regulatory Science & Policy EU/AMEE

Hélène  Bruguera

The International Pharmaceutical Regulators Programme (IPRP) Quality Working Group for Generics

Hélène Bruguera

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

Head, Certification of Substances Department,

Chantal  Walther, MPHARM

Learning from Reliance Programmes

Chantal Walther, MPHARM

Swissmedic, Switzerland

Head Regulatory Assessment Unit 4

Bernardo  Moreira

Q&A and Panel Discussion, with the additional participation of

Bernardo Moreira

Brazilian Health Regulatory Agency (ANVISA), Brazil

Second Directory Assessor (DIRE2)

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