Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join


Mar 14, 2022 10:00 AM - Mar 16, 2022 3:15 PM

(US Eastern Standard Time)

Latin America Regulatory Conference

DIA Your Way! Join us virtually from the comfort of your home/office March 14-16 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Welcome to Day Three and Session 7: Improving Manufacturing: Lessons from mRNA Vaccines

Session Chair(s)

Maria  Guazzaroni Jacobs, PhD

Maria Guazzaroni Jacobs, PhD

Director, Quality Intelligence, Global Supply

Pfizer Inc, United States

Maria Antonieta Tony Roman, MPharm

Maria Antonieta Tony Roman, MPharm

Head Regulatory Policy Emerging Markets LATAM

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


Connie  Langer, MSc

Lessons Learned/Opportunities – Related to Vaccine Manufacturing

Connie Langer, MSc

Pfizer Inc, United States

Senior Director

Tomas  Pippo


Tomas Pippo

Pan American Health Organization (PAHO), United States

Advisor, Pharmaceutical Policies and Innovation

Samuel  Simons, MSc


Samuel Simons, MSc

Sanofi, United States

Director, Global Regulatory Team Leader

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.