Latin America Regulatory Conference

Join global regulators, industry, and academia to engage in a series of strategic discussions on current regulatory landscape, globalization, and harmonization initiatives in Latin America.

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Session 6: New Trends in Regulatory Science

Session Chair(s)

Maria Cristina Mota Pina, MBA

Head, Regulatory Policy for Emerging Markets -Japan and Australia

AbbVie, United States

The focus of the session includes the perspective of the US FDA with their new CMC regulation for Human Gene Therapy Investigational for New Drug Applications, real world evidence, and the regulatory decision-making process, and how digital initiatives can transform the way we are currently developing and registering new products globally.

Learning Objective :
Understand the global regulatory trends and their possible application in the Latin America region
Understand the challenges of the Gene Therapy CMC aspects and how the US FDA is thinking on regulating them
Understand how the new technology developments are supporting the development of new products and how this can be of use in the regulatory decision-making process globally and the Latin America region

Speaker(s)

Regulatory update for Cell and Gene Therapies

Michael Havert, PhD

StrideBio, United States

Vice President, Regulatory Affairs

Challenges in the regulation of cell therapy products: Regional situation and recommendations endorsed by the IX Pan American Network for Drug Regulatory Harmonization Conference (CPANDRH), 19- 21 October 2018, El Salvador

Analia Porras

Pan American Health Organization (PAHO), United States

Unit Chief, Medicines and Health Technologies

Trends in Regulatory Science from Global to Latin America Reality

Esther Avila

Pfizer Inc, United States

Head of Latin America, Worldwide Safety & Regulatory-Innovative

Trends in Regulatory Science from Global to Latin America Reality

Denise Bonamici, MSc

Sanofi, Brazil

Head of Regulatory Science and Policy - LATAM

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Latin America Regulatory Conference

Session 6: New Trends in Regulatory Science

Session Chair(s)

Maria Cristina Mota Pina, MBA

Speaker(s)

Regulatory update for Cell and Gene Therapies

Challenges in the regulation of cell therapy products: Regional situation and recommendations endorsed by the IX Pan American Network for Drug Regulatory Harmonization Conference (CPANDRH), 19- 21 October 2018, El Salvador

Trends in Regulatory Science from Global to Latin America Reality

Trends in Regulatory Science from Global to Latin America Reality

Be informed and stay engaged.