Janet Woodcock, M.D. Principal Deputy Commissioner - Office Of The Commissioner
U.S. Food and Drug Administration (FDA)
ABOUT THIS CONFERENCE
CDER SBIA is hosting this three half-days conference in collaboration with the Promoting the Quality of Medicines Plus (PQM+) program, which is funded by the U.S. Agency for International Development (USAID) and led by the United States Pharmacopeial Convention. PQM+ provides technical assistance to build in-country capacity of medical products regulatory authorities’ QA systems in low-and middle-income countries (LMICs). PQM+ also provides technical support to manufacturers of quality-assured priority medical products for tuberculosis (TB), malaria, neglected tropical diseases, other infectious diseases, and family planning and reproductive health as well as maternal, newborn, and child health.
This event is intended to help National Medicines Regulatory Authority's (NMRA) in low-and middle-income countries (LMICs) gain a better understanding of the following:
FDA's role in international regulatory harmonization.
How FDA interacts with the World Health Organization (WHO) and NMRAs to support the process for approving drugs in LMICs.
USP and USAID’s PQM+ program’s role in supporting of strengthening regulatory systems in LMICs.
Regulatory resources available to NMRAs in LMICs.
International Regulatory Harmonization
FDA International Collaborations, including WHO
FDA drug approval pathways and FDA review of drug applications (new and generic drugs). Specific emphasis will be made on approval pathways for new TB medicines.
FDA review of stability testing, bioequivalence and post-marketing changes
USP and USAID’s PQM+ capabilities for strengthening regulatory systems in LMIC.
Global regulators, particularly those from low- and middle-income countries (LMICs)
Regulatory science and regulatory affairs professionals, industry, consultants, or contractors who are involved with:
The submission of INDs, NDAs, BLAs and ANDAs
New and generic drug development
Generic drug bioequivalence, stability, biowaivers and dissolution
Global public health programs supporting access to quality-assured medicines