Medical Product Regulatory Systems Strengthening and Challenges in Low and Middle Income Countries

2 Credits.

Covers history, organization, funding, functions, major current forces like globalization, etc. shaping regulatory systems. Distinguishes differences between high-income and LMIC systems; major failures and public health crises; role of WHO, and other factors, such as donors in strengthening; assessing regulatory systems for improvement; working together across countries; using the work product of other agencies to do more with less; Africa Regional Economic Communities, African Medicines Agency, Caribbean Regulatory System; substandard/falsified medicines; difficulties using the work product of other agencies; regulatory system and procurement disconnects; companies sending lower tiered versions to LMIC; lack of medical device regulation; etc.