Royal Tulip Brasília Alvorada Hotel

2024年9月25日 (水) 午前 8:00 - 2024年9月26日 (木) 午後 4:00

Shtn - Trechno 01, Conj 1Bb - Bloco C, 40800-200 Brasília, Brazil

Latin America Annual Meeting

Session 3, Track A: Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence

Session Chair(s)

Maria Antonieta  Roman, MPharm

Maria Antonieta Roman, MPharm

Head Regulatory Policy LaCan

Novartis, Mexico

Leonardo  Semprun, PharmD

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)

Ana Carolina  Moreira Marino Araujo, PharmD

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

Luis Rodrigo  Pineiro, MA

Regulatory Collaboration and Cooperation: Convergence & Harmonization

Luis Rodrigo Pineiro, MA

ANMAT Ministry of Health, Argentina

Director of Institutional Relations

Margarita  Contreras Olvera

Exploring the Present and Future of Regulatory Cooperation, Collaboration and Convergence

Margarita Contreras Olvera

COFEPRIS, Mexico

Official of International Affairs Office

Flavia  Firmino Ribeiro, PharmD

Regional Collaboration and Engagement through ICH – IFPMA’s role

Flavia Firmino Ribeiro, PharmD

Eli Lilly and Company, Brazil

Global Regulatory Policy Lead Latin America

Juliana  Perlow

PIC/S in Latin America: Harmonization of cGMP Procedures

Juliana Perlow

MSD, Brazil

Executive Director, Regulatory Affairs CMC – Latin America

Maria  del Pilar Hernández Svendblad, MHS

Regulatory Collaboration and Cooperation Initiatives Combined with Regulatory Convergence and Harmonization

Maria del Pilar Hernández Svendblad, MHS

Sanitary Regulation Superintendency, El Salvador

Head of the Records and Registrations Operations Office

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