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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
MSD, Panama
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)
Opportunities for Greater Convergence in Latam
Lawrence Liberti, PhD, RAC
The Kim Center/ USC DRQS, United States
Director, D.K. Kim International Center for Regulatory Science
Overview - Medicines Assessed Under the ‘EU-M4all’ Procedure
Martin Harvey Allchurch, LLM
European Medicines Agency, Netherlands
Head of International Affairs
Lessons Learned from Collaboration and Convergence Initiatives
Gustavo Mendes Lima Santos, MPharm
Brazilian Health Regulatory Agency (ANVISA), Brazil
Herbal and Complementary Medicines Office - GMESP
Agency Lessons Learned from Collaboration and Convergence Initiatives
Heriberto Enrique García Escorza, MPA, RPh
Instituto de Salud Pública de Chile, Chile
Director
Regulatory Convergence - Industry Perspective (Medicines)
Angelika Joos, MPharm
MSD, Belgium
Executive Director, Global Regulatory Policy
Regulatory Convergence - Industry Perspective (Medical Technology)
Sandra Ligia González Aguirre
Inter-American Coalition For Regulatory Convergence, Medical Technology Sector, United States
Executive Secretary, Inter-American Coalition for Regulatory Convergence
Speaker
Miriam Jackeline Jackeline Loera Rosales
COFEPRIS, Mexico
Commissioner of Evidence and Risk Management
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