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WHO Townhall - Navigating Regulatory Frontiers: WHO Listed Authorities, Facilitated Product Introduction, Strengthening Clinical Trials, and Efforts to Preserve Antimicrobials
Session Chair(s)
Samvel Azatyan, MD, PhD
Team Lead, Regulatory Convergence and Networks (RCN/REG)
World Health Organization (WHO), Switzerland
Regulatory systems strengthening activities play a crucial role in assisting countries in identifying and addressing gaps through the utilization of benchmarking tools. These activities also aim to enhance capacity, working towards achieving a more stable maturity level, specifically ML3, as outlined in WHA Resolution 67.20. As we approach 2024, a pivotal moment awaits the WHO Listed Authorities (WLAs) initiative, marked by the expansion of the WLAs network.
The WLA scheme is designed to establish a transparent system, enabling National Regulatory Authorities (NRAs) to effectively execute Facilitated Product Introduction activities. This approach, grounded in the concept of regulatory reliance, empowers NRAs in their national decision-making processes. It leverages the wealth of information available from an expanded pool of trusted regulatory authorities.
In May 2022, the Seventy-fifth World Health Assembly adopted Resolution WHA75.8, focusing on "Strengthening clinical trials to provide high-quality evidence on health interventions to improve research quality and coordination." An update on the progress of these ongoing activities will be provided. The WHO will present an update on the 1st Global Joint Summit of Human and Veterinary Medicines Regulatory Authorities dedicated to Preserving Antimicrobials. This update will emphasize the transformative role of regulators in fortifying national systems, with a specific focus on reducing antimicrobial usage in the human, animal, and agricultural sectors. Our guest speaker representing European Medicines Agency will present on the Synergies of EMA activities: Reliance and collaboration as 21st century regulatory tools.
During the session, key elements of the WHO's regulatory system strengthening, WLA initiative, WHA75.8 resolution, and Antimicrobial Resistance (AMR) activities will be introduced. A comprehensive discussion will follow, exploring the impact and implementation of these initiatives in collaboration with various stakeholders, including EMA.
Speaker(s)
Coordinated Efforts for Regulatory System Strengthening, Reliance, and WLA
Alireza Khadem Broojerdia
WHO, Switzerland
Team Lead, Regulatory System Strenghtening
Empowering Regulatory Authorities: Unlocking the Potential of WLA Scheme for Facilitated Product Introduction and Regulatory Reliance
Marie Valentin, PharmD
WHO, Switzerland
Team Lead, Facilitated Product Introduction
WHA75.8 on Strengthening Clinical Trials to Provide High-Quality Evidence
Vasee Moorthy
WHO, Switzerland
Senior Advisor, Science Division
1st Global Joint AMR Summit: Regulators as Critical Partners in the Global AMR Response
Jean Pierre Nyemazi, MD, MS
WHO, Switzerland
Unit Head, Governance and Strategic Initiative, AMR Division
Synergies of EU Activities and International Collaboration
Martin Harvey Allchurch, LLM
European Medicines Agency, Netherlands
Head of International Affairs
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