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Royal Tulip Brasília Alvorada Hotel

Sep 25, 2024 8:00 AM - Sep 26, 2024 4:00 PM

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

Latin America Annual Meeting

Take advantage of opportunities for networking and knowledge sharing with key stakeholders influencing the advancement and implementation of initiatives in Latin America.

Session 9 Plenary: Fostering Regional Initiatives to Enhance Regulatory Capacity and Strengthen Health Systems

Session Chair(s)

Leonardo  Semprun, PharmD

Leonardo Semprun, PharmD

Global Regulatory Policy Lead-LatAm

MSD, Panama

Duglas  Rodriguez Calderon, MSc

Duglas Rodriguez Calderon, MSc

Global Head of LATAM Regulatory Policy, Global Regulatory Policy & Intelligence

Roche, United States

The session focuses on the rationale and importance of building regulatory capacity in the Americas to promote and protect public health. National regulatory systems play a crucial role in ensuring the quality, safety, and efficacy of health technologies. However, evolving scientific advancements, globalization, and diverse product landscapes pose challenges in effectively overseeing these technologies. One of the goals of regulatory capacity building is to improve access to safe, effective, and innovative medicines. Inefficient regulatory systems can hinder access to quality medical products.

This session aims to galvanize mutual expertise and experience-sharing among regulators in the Americas, fostering a collaborative network to sustain robust regulatory agencies and for advancing regulatory practice to meet the potential of novel treatments, vaccines, diagnostics, and medical devices. The session explores strategies for enhancing regulatory capacity through collaboration, knowledge sharing, and fostering initiatives for joint work and collaboration. It discusses challenges, opportunities, and best practices in capacity building efforts, aiming to identify ways to promote collaboration and joint initiatives among regulators, universities, and industry stakeholders. By leveraging capacity building efforts, participants can enhance their ability to work together, share resources, and address common challenges in regulatory systems strengthening.

Additionally, the session engages in a discussion on existing models of capacity building in regulatory systems. By analyzing and comparing these models, participants can identify best practices, lessons learned, and innovative approaches that can be applied to strengthen regulatory systems in the Americas. This discussion aims to foster collaboration and knowledge exchange among participants, promoting the adoption of effective capacity building strategies that support collaborative initiatives.

Learning Objective :
  • Discuss capacity building models for regulatory systems strengthening, identifying best practices and lessons learned
  • Highlight the importance of robust regulatory systems in promoting public health and ensuring access to safe and effective health technologies
  • Explore strategies for enhancing regulatory capacity through collaboration, knowledge sharing

Speaker(s)

Michelle  Limoli, PharmD, RPh

Opportunities for International Harmonization & Regulatory Convergence: Regulatory Perspectives

Michelle Limoli, PharmD, RPh

FDA, United States

Associate Director, International Programs

Patricia  Wu, MBA

Americas RISE for Health

Patricia Wu, MBA

Americas Business Dialogue, United States

Chair, Health Working Group

Jared  Auclair, PhD

America Rise for Health: Regulatory Training

Jared Auclair, PhD

Northeastern University, United States

Interim Dean and Professor

Augusto  Bencke Geyer, MSc

Speaker

Augusto Bencke Geyer, MSc

ANVISA, Brazil

Health Regulatory Expert, International Affairs Office

Lawrence  Liberti, PhD, RAC

Speaker

Lawrence Liberti, PhD, RAC

The Kim Center/ USC DRQS, United States

Director, D.K. Kim International Center for Regulatory Science

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