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Session 2, Part I: Agencies expectations/opportunities and Industry challenges and proposed outlook
Session Chair(s)
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
Sylvie Meillerais, MSc
Director Global CMC Policy
MSD Belgium, Belgium
Building on the previous session, this session will explore more specific CMC considerations moving forward and learnings from, for example, remote inspections and will gather learnings on the use and benefits that electronic CPPs can provide in a time of crisis and beyond.
Speaker(s)
EFPIA White Paper on CMC development, manufacturing and supply of pandemic COVID-19 therapies and vaccines
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
Remote Inspections
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
EMA Perspective on eCPPs
Alberto Ganan Jimenez, PhD
European Medicines Agency, Netherlands
Head of Committees and Quality Assurance
Industry Mapping on eCPP
Susanne Ausborn, PhD
Roche, Switzerland
Global Head International Regulatory Policy
IFPMA eCPP Position Paper
Nevena Miletic
Roche, Switzerland
Regulatory Policy Lead
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