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Session 3, Track A: Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence
Session Chair(s)
Maria Antonieta Roman
Head Regulatory Policy LaCan, Novartis, Mexico
Leonardo Semprun, PHARMD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
Regulatory collaboration and cooperation are becoming increasingly important, given the growth in regulatory procedures related to innovative therapies, or with post-registration changes and limited resources. In this session, we will learn about agreements and experiences; we will also discuss harmonization efforts, plans and challenges in the Latin American region, explore issues related to regulatory harmonization, resource allocation, and overcoming regulatory disparities among countries. Examine the role and contribution of various sectors, including industry and academia, in the evolution of ICH standards. Discuss how collaboration between regulatory agencies and these sectors can enhance the development and implementation of effective regulatory frameworks.
Learning Objective : - Analyze the importance of collaboration and regulatory cooperation in the context of regional regulatory frameworks
- Identify the challenges and opportunities associated with collaborations and regional mechanisms
- Evaluate the implementation status of ICH guidelines in regulatory frameworks
- Analyze the challenges and obstacles faced in the adaptation and implementation of ICH guideline frameworks
Speaker(s)
Ana Carolina Moreira Marino Araujo
Head, International Affairs Office, ANVISA, Brazil
Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence
Luis Rodrigo Pineiro, MA
Director of Institutional Relations, ANMAT Ministry of Health, Argentina
Regulatory Collaboration and Cooperation: Convergence & Harmonization
Margarita Contreras Olvera
Official of International Affairs Office , COFEPRIS, Mexico
Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence
Flavia Firmino, PHARMD
Regulatory Policy Lead - Latin America, Eli Lilly and Company, Brazil
Regional Collaboration and Engagement through ICH – IFPMA’s role
Juliana Perlow
Executive Director, Regulatory Affairs CMC – Latin America, MSD, Brazil
PIC/S in Latin America: Harmonization of cGMP Procedures
María del Pilar Hernández Svendblad, MSC
Head of the Operations Office for the Registration and Market Authorizations Int, Sanitary Regulation Superintendency, El Salvador
Regulatory Collaboration and Cooperation Initiatives Combined with Regulatory Convergence and Harmonization
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