The 19th International Conference of Drug Regulatory Authorities (ICDRA) will take place October 14-18 in New Delhi, India. Hosted by the World Health Organization (WHO) and India’s Central Drugs Standard Control Organization (CDSCO) and Ministry of Health and Family Welfare, this year’s theme is “Smart regulation: Delivering quality assured medical products for all.” The conference brings together hundreds of regulators from WHO member states, government officials, manufacturers, academics, research institutions, and non-profit organizations to discuss strategies for strengthening regulatory systems, including improving quality assurance, safety monitoring, regional harmonization, and other important functions.
USP participation
Pharmacovigilance Partners Meeting
Sunday, October 13, 1– 6pm IST
This side meeting highlights how countries can manage competing pharmacovigilance priorities by focusing on priority products, sharing resources and information, and building national competence for activities that can’t be delegated. Participants will discuss a global strategy of smart pharmacovigilance, the key principles of such a strategy, and a broad framework for implementation.
Workshop 1: Sustainable Local Production of Quality Assured Medical Products
Monday, October 14, 1:30 pm – 3pm IST
This workshop outlines how regulators can promote sustainable local production, facilitate technology transfer, and build resilient, self-reliant local industries for medical products with support from the WHO Local Production and Assistance (LPA) unit. As part of the workshop, USP will moderate a panel discussion entitled, “Bridging the gap: Regulatory information transfer in pharmaceutical manufacturing” to highlight the importance of sharing data and information to inform regulatory decision-making, improve regional harmonization, and facilitate quicker and safer access to medical products worldwide.
USP Speaker: Dr. Emily Kaine, Senior Vice President, Global Health and Manufacturing Services, USP
Workshop 2: Strengthening Regulatory Systems Through Partnerships: CIP
Monday, October 14, 1:30 pm – 3pm IST
In 2021, WHO launched the Coalition of Interested Parties (CIP) network to advance regulatory systems strengthening. This workshop highlights CIP’s progress to date in supporting national regulatory authorities (NRAs) toward achieving WHO Maturity Level 3-4 and beyond, including supporting key regulatory functions like registration and market authorization, regulatory inspection, market surveillance and control, laboratory testing, lot release, and more.
USP Speaker: Jude Nwokike, VP & Director of Promoting the Quality of Medicines Plus (PQM+), USP
View the program: https://www.icdra2024.in/ICDRA/Homepage
Not able to join? Follow us @USPGlobalHealth for updates. #ICDRA2024
Strengthening regulatory systems
Bolstering national and regional authorities to improve access to medicines
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Expanding manufacturing capacity
Producing medicines closer to patients to advance health equity
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