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Session 4: Evolution in Manufacturing / Advanced Therapies
Session Chair(s)
Maria Guazzaroni Jacobs, PhD
Director, Quality Intelligence, Global Supply , Pfizer Inc, United States
Due to the pandemic, 2020 has seen new technologies being advanced, many in search for vaccines for COVID-19. In this session, participants will hear from industry on experience and lessons learned advancing vaccine manufacturing, as well as the considerations from a quality perspective, including alliances with other companies, quality agreements and qualification of suppliers.
The session will continue with a second industry presentation focused on quality considerations for ATMPs and a representative from ANVISA on the regulatory model for ATMPs including risk/benefit assessment and challenges in application of GMPs.
Learning Objective : At the conclusion of this session, participants should be able to:- Discuss quality considerations in manufacturing of ATMPs
- Learn from regulators on ATMP’s GMP standards and the regulatory model for Advance Therapies
Speaker(s)
COVID Vaccine – Development and Current Status
Pamela Siwik, MBA
Vice President, Pfizer Global Supply Rare Diseases and New Modalities and New Pr, Pfizer Inc., United States
COVID-19 Vaccine Quality and Compliance Summary
Jennifer E. Sloan, MS
Director, PSQA BTx Portfolio, Pfizer Global Supply, Pfizer Inc., United States
Quality Considerations of ATMPs
Joerg Garbe, PhD, MSc
IFPMA In-Country Testing Taskforce Lead; Global Quality Manager & Policy Lead, F. Hoffmann-La Roche Ltd, Switzerland
Anvisa´s Regulatory Model in ATMP-GMP
Renata Miranda Parca, AHIP
Health regulatory specialist, ANVISA, Brazil
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