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Session 6: New Trends in Regulatory Science
Session Chair(s)
Maria Cristina Mota Pina, MBA
Director, Regulatory Policy and Intelligence -Japan, Emerging Markets, Australia
Latin America Federation of Pharmaceutical Industry (FIFARMA), 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 :
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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