概览
This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective. With topics ranging from reliance, regulatory convergence and harmonisation to ICH guidelines’ update, lifecycle management, inspections PBBM modelling, and many other key topics within this space, this Workshop will be a prime opportunity to discuss lessons learned, challenges, and the next steps which will be necessary to drive us towards the future.
Designed to allow engaging dialogue with experts from Regulatory Agencies, International Organisations, and experts from Industry, this Workshop will enable you to partake in interactive cross-functional discussions and hear directly from key stakeholders in this space.
项目委员会
-
Ben Thompson Vice President, CMC and Non-clinical Regulatory Affairs
GlaxoSmithKline, United Kingdom -
Frank Montgomery, PhD Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom -
Susanne Ausborn, PhD Global Head International Regulatory Policy
Roche, Switzerland -
Sylvie Meillerais, MSc Head of CMC Excellence
Institut De Recherches Internationales Servier, France -
Sara Torgal, MPharm Global Regulatory Policy Lead
DIA, Switzerland
