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Session 7: Reliance Programmes
Session Chair(s)
Frank Montgomery, PhD
Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Session 7: Reliance Programmes
Speaker(s)
Overview of the Reliance Programmes Available Globally
Rebecca Lumsden, PhD
Sanofi, United Kingdom
Head of Regulatory Science & Policy EU/AMEE
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,
Learning from Reliance Programmes
Chantal Walther, MPharm
Swissmedic, Switzerland
Head Regulatory Assessment Unit 4
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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