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Latin America Regulatory Conference


Session 4: Evolution in Manufacturing / Advanced Therapies

Session Chair(s)

Maria  Guazzaroni Jacobs, PhD

Maria Guazzaroni Jacobs, PhD

  • Director, Quality and Regulatory Policy (QRP), 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

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
Jennifer E. Sloan, MS

COVID-19 Vaccine Quality and Compliance Summary

Jennifer E. Sloan, MS

  • Director, PSQA BTx Portfolio, Pfizer Global Supply
  • Pfizer Inc., United States
Joerg  Garbe, PhD, MSc

Quality Considerations of ATMPs

Joerg Garbe, PhD, MSc

  • Global Quality Manager & Policy Lead
  • F. Hoffmann-La Roche Ltd, Switzerland
Renata  Parca

Anvisa´s Regulatory Model in ATMP-GMP

Renata Parca

  • ANVISA, Brazil

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