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Accelerating CMC Workshop

Innovation and Convergence in a post COVID-19 world


Session 1: Global Post-Approval Changes: leveraging the experience with the COVID-19 vaccines and treatments

Session Chair(s)

Frank  Montgomery, PhD

Frank Montgomery, PhD

  • Global Head Regulatory CMC, GRAPSQA
  • AstraZeneca, United Kingdom
Susanne  Ausborn, PhD

Susanne Ausborn, PhD

  • Global Head International Regulatory Policy
  • F. Hoffmann-La Roche Ltd., 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)

Sau L Lee, PhD

Regulatory Approaches to Enabling Manufacturing Capacity in the COVID-19 Pandemic

Sau L Lee, PhD

  • Deputy Director of Science, OPQ, CDER
  • FDA, United States
Sean  Barry, PhD

Regulator Perspective

Sean Barry, PhD

  • Executive Pharmaceutical Assessor
  • Health Products Regulatory Authority (HPRA), Ireland
Connie  Langer, MSc

Case Study: COVID-19 Vaccine Regulatory & Technical Learnings & Recommendations

Connie Langer, MSc

  • Director, Global CMC
  • Pfizer Inc, United States
Diane  Wilkinson, PhD, RPh

Industry Perspective on Experiences through COVID 19 Vaccines and treatments

Diane Wilkinson, PhD, RPh

  • Senior Director, Global CMC Regulatory Affairs
  • Astrazeneca, United Kingdom
Mohammed H. Aldosari, PhD

Saudi FDA experience during COVID-19

Mohammed H. Aldosari, PhD

  • Biologics CMC Expert
  • Saudi Food and Drugs Authority, Saudi Arabia
Raphael  Sanches Pereira

Panel discussion with Q&A, with the additional participation:

Raphael Sanches Pereira

  • Health and Regulation Expert / Office Manager
  • ANVISA, Brazil