返回 Agenda
Welcome to Day Three and Session 7: Improving Manufacturing: Lessons from mRNA Vaccines
Session Chair(s)
Maria Guazzaroni Jacobs, PhD
Director, Quality Intelligence, Global Supply
Pfizer Inc, United States
Maria Antonieta Roman, MPharm
Head Regulatory Policy LaCan
Novartis, Mexico
The session will start with a discussion of the WHO guideline on “Evaluation of the quality, safety and efficacy of messenger RNA vaccines for the prevention of infectious diseases: regulatory considerations” which discusses key aspects of manufacture and quality control, and the nonclinical and clinical evaluation of preventive mRNA vaccines for human use. It will also include initiatives to foster COVID19 vaccine production in Latin America. The session will continue with an industry representative who will present the joint industry proposal titled, “Recommendations to Support the Rapid Increase of Manufacturing Capacity for the Production of COVID-19 Therapeutics and Vaccines”, that was submitted to International Coalition of Medicines Regulatory Authorities (ICMRA) and discussed at the ICMRA workshop in July 2021. Finally, lessons learned by the regulators will be highlighted.
Learning Objective : At the conclusion of this session, participants should be able to:- Describe the WHO mRNA vaccines guideline
- Identify ways to increase manufacturing capacity
- Discuss learnings and opportunities in the Latin America region with respect to vaccines
Speaker(s)
Lessons Learned/Opportunities – Related to Vaccine Manufacturing
Connie Langer, MSc
Pfizer Inc, United States
Senior Director
Speaker
Tomas Pippo
Pan American Health Organization (PAHO), United States
Advisor, Pharmaceutical Policies and Innovation
Speaker
Samuel Simons, MSc
United States
Director, Global Regulatory Team Leader