Regulatory Best Practices for Global Access to Medicines Including Anti-TB Medicines Day 1-Session 1

CDER SBIA hosted a three, half-day conference in collaboration with the Promoting the Quality of Medicines Plus (PQM+) program. Which is intended to help National Medicines Regulatory Authority's (NMRA) in low-and middle-income countries (LMICs) gain a better understanding of FDA's role in international regulatory harmonization, and regulatory resources available to NMRAs in LMICs. Presentations covered topics such as FDA drug approval pathways and FDA review of drug applications (new and generic drugs) with specific emphasis on approval pathways for new TB medicines, and USP and USAID’s PQM+ capabilities for strengthening regulatory systems in LMIC.

Timestamps

00:42 – FDA Keynote

11:58 – USAID Keynote

22:23 – WHO Keynote

50:20 – USP Keynote

54:25 – Promoting the Quality of Medicines Plus (PQM+) Program

1:02:51 – WHO Prequalification Process for Medicines: Collaborative Registration Procedure for WHO Prequalified Medicines

1:51:28 – Collaborative Registration Procedure for WHO Prequalified Medicines and Its Impact on Accelerated Registration and Timely Access to Quality-assured Medicines in LMICs

2:09:42 – Questions & Answer Panel

Speakers:

Janet Woodcock, MD
Principal Deputy Commissioner
Office of The Commissioner
U.S. Food and Drug Administration (FDA)

Dr. Atul Gawande
Assistant Administrator for Global Health
United States Agency for International Development (USAID)

Tereza Kasaeva, MD, PhD
Director
Global TB Programme
World Health Organization (WHO)

Rogerio Gaspar, PhD
Director of Regulation and Prequalification
WHO

Ronald T. Piervincenzi, PhD
Chief Executive Officer
United States Pharmacopeia (USP)

Jude Nwokike
Vice President & Director
Promoting the Quality of Medicines Plus (PQM+) Program
U.S. Pharmacopeial Convention

Deus Mubangizi
Unit Head, Prequalification Unit (PQT)
Regulation and Prequalification Department (RPQ)
Access to Medicines and Health Products Division (MHP)
World Health Organization (WHO)

Hiiti B. Sillo
Unit Head, Regulation and Safety
RPQ | MHP | WHO

Panelists:

Deus Mubangizi
Unit Head, Prequalification Unit (PQT)
Regulation and Prequalification Department (RPQ)
Access to Medicines and Health Products Division (MHP)
World Health Organization (WHO)

Hiiti B. Sillo
Unit Head, Regulation and Safety
RPQ | MHP | WHO

Learn more at: Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines - 08/16/2022 | FDA

-----------------------

FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accoun...
SBIA 2022 Playlist -    • 2022 CDER Small Business and Industry...  
SBIA LinkedIn -   / cder-small-business-and-industry-assistance  
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter -   / fda_drug_info  
Email - [email protected]
Phone - (301) 796-6707 I (866) 405-5367