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Accelerating CMC Workshop
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
- F. Hoffmann-La 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
- Deputy Director of Science, OPQ, CDER
- FDA, United States
Regulator Perspective
Sean Barry, PhD
- Executive Pharmaceutical Assessor
- Health Products Regulatory Authority (HPRA), Ireland
Case Study: COVID-19 Vaccine Regulatory & Technical Learnings & Recommendations
Connie Langer, MSc
- Director, Global CMC
- Pfizer Inc, United States
Industry Perspective on Experiences through COVID 19 Vaccines and treatments
Diane Wilkinson, PhD, RPh
- Executive Director, Global CMC Regulatory Affairs
- AstraZeneca, United Kingdom
Saudi FDA experience during COVID-19
Mohammed H. Aldosari, PhD
- Biologics CMC Expert
- Saudi Food and Drugs Authority, Saudi Arabia
Panel discussion with Q&A, with the additional participation:
Raphael Sanches Pereira
- Health and Regulation Expert / Office Manager
- ANVISA, Brazil
