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Session 1: Global Post-Approval Changes: leveraging the experience with the COVID-19 vaccines and treatments
Session Chair(s)
Frank Montgomery, PhD
Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom
Susanne Ausborn, PhD
Global Head International Regulatory Policy
Roche, Switzerland
The COVID-19 crisis has forced regulators and industry to think differently to accelerate approval and supply of desperately needed vaccines and medicines. This session, with input from WHO and global health authorities, will look at these innovations, how they can be broadened to expand ongoing covid vaccine and therapeutics supply and discuss how we could sustain them post pandemic to help resolve the desperate problems associated with global post approval CMC changes.
Speaker(s)
Regulatory Approaches to Enabling Manufacturing Capacity in the COVID-19 Pandemic
Sau L Lee, PhD
FDA, United States
Deputy Super Office Director, OPQ, CDER
Regulator Perspective
Sean Barry, PhD
Health Products Regulatory Authority (HPRA), Ireland
Senior Pharmaceutical Assessor
Case Study: COVID-19 Vaccine Regulatory & Technical Learnings & Recommendations
Connie Langer, MSc
Pfizer Inc, United States
Senior Director
Industry Perspective on Experiences through COVID 19 Vaccines and treatments
Diane Wilkinson, PhD, RPh
AstraZeneca, United Kingdom
Executive Director, Global CMC Regulatory Affairs
Saudi FDA experience during COVID-19
Mohammed H. Aldosari, PhD
Saudi Food and Drug Authority (SFDA), Saudi Arabia
Director of Biological Products Directorete
Panel discussion with Q&A, with the additional participation:
Raphael Sanches Pereira
ANVISA, Brazil
General Manager of the Office for Medicines