221.675.73
Medical Product Regulatory Systems Strengthening and Challenges in Low and Middle Income Countries

Location
Internet
Term
Winter Institute
Department
International Health
Credit(s)
2
Academic Year
2024 - 2025
Instruction Method
Synchronous Online
Start Date
Tuesday, January 14, 2025
End Date
Friday, January 17, 2025
Class Time(s)
Tu, W, Th, F, 9:00am - 12:50pm
Auditors Allowed
Yes, with instructor consent
Available to Undergraduate
No
Grading Restriction
Letter Grade or Pass/Fail
Contact Name
Elisabeth Simmons
Frequency Schedule
One Year Only
Next Offered
Only offered in 2024
Description
-Are you interested in global health policy? -Are you interested in learning how an effective medical products regulatory system is an integral part of a quality health system? -Are you interested in learning more about regulatory systems for medical products, how they can be strengthened, and why they are so important to global health? -This course will give students an introduction to a field of global health that is not as well known as other fields like disease surveillance, or maternal newborn child health, but that is cross-cutting and dramatically impacts health in a way that is arguably as significant as any other health systems pillar.
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 BMGF 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; 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.
Learning Objectives
Upon successfully completing this course, students will be able to:
  1. Describe major features of the history, organization, funding, functions, and forces shaping regulatory systems for medical products in high income and LMIC countries, including differences between high and LMIC systems, why systems fail, and major actors (and their respective roles) working to improve LMIC systems.
  2. Explain and analyze current challenges related to regulatory systems in LMIC including financial and human resources; substandard/falsified medicines; clinical trials oversight and harmonization; using the work product of other agencies (reliance); regulatory system and procurement disconnects; companies sending lower tiered versions of products to LMIC, etc. and strategies to address these areas.
  3. Examine the benefits and limitations of various strategies to strengthen LMIC regulatory systems, given current LMIC challenges.
  4. Assess LMIC country situations and design plans for strengthening systems, including develop metrics for evaluation of success.
Methods of Assessment
This course is evaluated as follows:
  • 15% Participation
  • 45% Group Presentation
  • 40% Final Exam
Instructor Consent
No consent required
Special Comments

Course being taught by Charles Preston and Murray Lumpkin