With the financial support from USAID/Philippines, USAID/Indonesia, and the Presidential Malaria Initiative through USAID/RDMA, the Promoting the Quality of Medicines (PQM) program conducted two successful training workshops in conjunction with the ASEAN Pharmaceutical Product Working Group for the medicines regulatory agencies of ASEAN member states.
In September more than 35 inspectors from ASEAN member states—Brunei, Myanmar, Cambodia, Indonesia, Laos, Malaysia, Philippines, and Vietnam—attended a workshop on Dossier Review & Good Manufacturing Practices (GMP) and Pharmaceutical Supply Chains Inspection led by the PQM technical team in Manila, Philippines.
The PQM technical team, in collaboration with the Philippines Food and Drug Administration, and ASEAN Secretariat, conducted a second training workshop for nine ASEAN member states—Myanmar, Cambodia, Indonesia, Laos, Malaysia, Philippines, Singapore, Thailand, and Vietnam—in October on Bioavailability and Bioequivalence (BA/BE) Studies.
The majority of the 39 participants were regulatory officers from national medicines regulation and registration agencies; others represented pharmaceutical manufacturers and contract research organizations with BE centers. The week-long workshop focused on the regulation and registration of generic drugs, providing participants with an opportunity to obtain essential knowledge and critical skills in BE study design, protocol review, good laboratory practices, and good clinical practices. Participants from Singapore, Thailand, Malaysia and Brunei were sponsored by their own institutions.
Source: Health Matters Newsletter RDMA/Office of Public Health