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Session 9 Plenary: Fostering Regional Initiatives to Enhance Regulatory Capacity and Strengthen Health Systems
Session Chair(s)
Leonardo Semprun, PHARMD
Global Regulatory Policy Lead-LatAm, Merck Sharp & Dohme LLC , United States
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
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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
Associate Director, International Programs, FDA, United States
Opportunities for International Harmonization & Regulatory Convergence: Regulatory Perspectives
Patricia Wu, MBA
Chair, Health Working Group, Americas Business Dialogue, United States
Americas RISE for Health
Jared Auclair, PHD
Interim Dean and Professor, Northeastern University, United States
America Rise for Health: Regulatory Training
Augusto Bencke Geyer, MSC
Health Regulatory Expert, International Affairs Office, ANVISA, Brazil
Speaker
Lawrence Eugene Liberti, RAC
Director, D.K. Kim International Center for Regulatory Science, The Kim Center/ USC DRQS, United States
Speaker
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