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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)
Pamela Siwik, MBA
Vice President, Pfizer Global Supply Rare Diseases and New Modalities and New Pr, Pfizer Inc., United States
COVID Vaccine – Development and Current Status
Jennifer E. Sloan, MS
Director, PSQA BTx Portfolio, Pfizer Global Supply, Pfizer Inc., United States
COVID-19 Vaccine Quality and Compliance Summary
Joerg Garbe, PHD, MSC
IFPMA In-Country Testing Taskforce Lead; Global Quality Manager & Policy Lead, F. Hoffmann-La Roche Ltd, Switzerland
Quality Considerations of ATMPs
Renata Miranda Parca, AHIP
Health regulatory specialist, ANVISA, Brazil
Anvisa´s Regulatory Model in ATMP-GMP
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