FDA to Host Multi-Day Global Access Virtual Conference

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FDA’s CDER SBIA is hosting a three-day virtual conference regarding regulatory best practices for global access to medicines.

FDA’s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) is hosting a three half-day virtual conference from August 16–18, 2022. The conference is in collaboration with the Promoting the Quality of Medicines Plus (PQM+) program, which is funded by the US Agency for International Development (USAID) and led by the United States Pharmacopeial Convention (USP).

The event is intended to help National Medicines Regulatory Authorities (NMRA) in low-and-middle income countries (LMICs) gain a better understanding of FDA’s role in international regulatory harmonization, USP and USAID’s PQM+ program’s role in supporting the strengthening of regulatory systems in LMICs, and more. Topics being covered include FDA drug approval pathways and FDA review of drug applications (new and generic drugs), specifically new TB medicines, FDA review of stability testing, bioequivalenceand post-marketing changes, nitrosamines impurities, and more.

Keynote speakers include FDA’s Janet Woodcock, MD, Principal Deputy Commissioner - Office of The Commissioner; USP CEO Ronald T. Piervincenzi, PhD; USAID’s Dr. Atul Gawande, Assistant Administrator for Global Health; WHO’s Tereza Kasaeva, MD, PhD, Director Global TB Programme; and Rogerio Gaspar, PhD Director of Regulation and Prequalification .


The event is virtual, and registration is free.

Source: FDA