Overview
This workshop will focus on current challenging topics in chemical manufacturing and controls (CMC) within the global pharmaceutical/ biopharmaceutical arena, such as Accelerated Development Programmes, Global Regulatory Convergence, and new & future ICH topics. The format will allow participants to engage in constructive dialogue with experts from Regulatory Agencies and Industry, enabling interactive cross-functional discussions.
Program Committee
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Frank Montgomery, PhD Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom -
Helen L Fitton Vice President Regional Regulatory Affairs (Pharma)
GlaxoSmithKline, United Kingdom -
Susanne Ausborn, PhD Global Head International Regulatory Policy
Roche, Switzerland -
Sylvie Meillerais, MSc Director Global CMC Policy
MSD Belgium, Belgium -
Ursula Busse, PhD, MBA Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
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