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Session 2, Part II : 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)
Global Regulatory Authorities reflect on Lessons Learned, with the presence of:
Ragini Shivji, PhD, RPh
European Medicines Agency, Netherlands
Principal Quality Specialist
Global Regulatory Authorities reflect on Lessons Learned, with the presence of:
Daniela Marreco Cerqueira, MS
ANVISA, Brazil
Associate Director, Third Directorate
Global Regulatory Authorities reflect on Lessons Learned, with the presence of:
Dmitriy Rozdestvensky, MD, PhD
Eurasian Economic Commission, Russian Federation
Head, Division for Coordination of Common Market for Drugs and Medical Devices F
Panel discussion with Q&A, with the additional presence of:
Matt Popkin, PhD
GSK, United Kingdom
Senior Director, CMC Excellence, Global Regulatory Affairs
Panel discussion with Q&A, with the additional presence of:
Stephan Roenninger, DrSc
Amgen (Europe) GmbH, Switzerland
Director, Quality External Affairs
Panel discussion with Q&A, with the additional presence of:
Nevena Miletic
Roche, Switzerland
Regulatory Policy Lead
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