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Session 3: Regulatory Convergence and Collaboration
Session Chair(s)
Roberta Mele Mazza, RPH, RAC
Q&RA Manager, División Diagnóstica, Productos Roche , Argentina
Leonardo Semprun, PHARMD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
Regulatory convergence takes many forms and represents an effort to improve the transparency and alignment of interactions between agencies and the industry regarding scientific principles, practices and procedures, as reflected in the acceptance of internationally recognized technical guidance documents and implementation of regulatory mechanisms that align with them. The purpose of this session is to bring together representatives of global regulatory bodies, industry and academia who are directly involved in the management of the regulatory process to exchange knowledge and experiences on the evolving regulatory environment of medical products regarding initiatives of convergence, both regional and international agencies, and understand how it helps streamline the regulatory process to facilitate the achievement of public health goals.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize trends on general collaboration for better convergence in the region and other international agencies
- Identify the opportunities offered by convergence in favor of improving transparency and alignment between agencies and industry
- Assess challenges and lessons learned about convergence initiatives in the region
Speaker(s)
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Martin Harvey Allchurch, LLM
Head of International Affairs, European Medicines Agency, Netherlands
Gustavo Mendes Lima Santos, MPHARM
Herbal and Complementary Medicines Office - GMESP, Brazilian Health Regulatory Agency (ANVISA), Brazil
Heriberto Enrique García Escorza, MPA, RPH
Director, Instituto de Salud Pública de Chile, Chile
Angelika Joos, MPHARM
Executive Director, Science & Regulatory Policy, MSD, Belgium
Sandra Ligia González Aguirre
Executive Secretary, Inter-American Coalition for Regulatory Convergence, Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States
Miriam Jackeline Jackeline Loera Rosales
Commissioner of Evidence and Risk Management, COFEPRIS, Mexico
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