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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!

Session 4 Follow Up: Transitioning EUA to Full Approvals: Regulatory Perspectives and Lessons for Future Pandemics

Session Chair(s)

Cammilla  Horta Gomes, MA, MPharm

Cammilla Horta Gomes, MA, MPharm

LATAM Regulatory Policy Lead

Roche, Brazil

Maria Antonieta Tony Roman, MPharm

Maria Antonieta Tony Roman, MPharm

Head Regulatory Policy Emerging Markets LATAM

Novartis, Mexico

Some regulatory agencies have established Emergency Use Authorization (EUA) to ensure that potentially lifesaving medical products could be available to people in medical need when there is not an approved and available alternative after demonstrating product effectiveness and that “potential benefits outweigh the known and potential risks”. Products that were granted EUA are expected to transition to full approvals, offering advantages for the public and pharmaceutical companies. This short session will highlight the FDA experience with accelerated timelines and need for risk-based decision-making during the COVID-19 pandemic, and present lessons that should be considered by regulators in Latin America and the Caribbean in preparation for future health emergencies.

Learning Objective : At the conclusion of this session, participants should be able to:
  • Recognize the differences between an emergency use authorization and a full approval
  • Describe the process for authorizing EUAs and the transition to full approval
  • Assess additional perspectives on EUAs


Peter P. Stein, MD


Peter P. Stein, MD

FDA, United States

Director, Office of New Drugs, CDER

Celia M. Witten, MD, PhD


Celia M. Witten, MD, PhD

FDA, United States

Deputy Director, Office of the Center Director, CBER

Melissa  Torres, MS


Melissa Torres, MS

FDA, United States

Associate Director for International Affairs, CDRH

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