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Session 1 Plenary: Regulatory System Strengthening: Updates on the Implementation of Good Regulatory Practices
Session Chair(s)
Lawrence Liberti, PhD, RAC
Director, D.K. Kim International Center for Regulatory Science
The Kim Center/ USC DRQS, United States
Susan Zavala Coloma, MS, RPh
Specialist, Sanitary Evaluation of Pharmaceutical Products, Biological Products
DIGEMID, Peru
This session will provide updates on Good Regulatory Practices in accordance with WHO guidelines, including the updates on the World Listed Authority (WLA), transitional WLAS status and the Global Benchmarking Tool (GBT) application. The objective of the session is to analyze current perceptions of key stakeholders regarding Good Regulatory Practices and their implementation in the regulatory field. The panel will include discussions regarding the challenges and obstacles identified in the implementation of Good Regulatory Practices and potential solutions or approaches to overcome them, also will identify existing opportunities for strengthening Good Regulatory Practices and improving the quality and safety of regulated products, both at the national and international levels. The discussions will facilitate the exchange of experiences and knowledge among regulators, industry, and other relevant stakeholders to promote collaboration and adoption of best regulatory practices, taking into account key elements of PAHO, and WHO regulatory system strengthening.