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Session 3, Track A: Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence
Session Chair(s)
Maria Antonieta Tony Roman, MPharm
Head Regulatory Policy Emerging Markets LATAM
Novartis, Mexico
Leonardo Semprun, PharmD
Global Regulatory Policy Lead-LatAm
MSD, Panama
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)
Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence
Ana Carolina Moreira Marino Araujo, PharmD
ANVISA, Brazil
Head of the International Affairs Office
Regulatory Collaboration and Cooperation: Convergence & Harmonization
Luis Rodrigo Pineiro, MA
ANMAT Ministry of Health, Argentina
Director of Institutional Relations
Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence
Margarita Contreras Olvera
COFEPRIS, Mexico
Official of International Affairs Office
Regional Collaboration and Engagement through ICH – IFPMA’s role
Flavia Firmino Ribeiro, PharmD
Pfizer, Brazil
Director Reg Global CMC
PIC/S in Latin America: Harmonization of cGMP Procedures
Juliana Perlow
MSD, Brazil
Executive Director, Regulatory Affairs CMC – Latin America
Regulatory Collaboration and Cooperation Initiatives Combined with Regulatory Convergence and Harmonization
Maria del Pilar Hernández Svendblad, MHS
Dirección Nacional de Medicamentos - DNM, El Salvador
Head of the Records and Registrations Operations Office
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