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Emerging Trends in Pharmaceutical Systems Strengthening

1st term
Online Programs for Applied Learning
3 credits
Academic Year:
2019 - 2020
Auditors Allowed:
Grading Restriction:
Letter Grade or Pass/Fail
Course Instructor :
  • Maria Karla Lin Eng
Maria Eng

Health systems experience preferred.


Have you wondered why we continue to worry about medicine access, delivery, safety, and quality? (Why can't we function like Coca-cola?) Access, delivery, appropriate use, and evaluation of pharmaceuticals among underserved populations and in global health settings remain challenging.

Explores pharmaceuticals management and universal health coverage effective, feasible frameworks and possible metrics to measure capacity and accountability. Considers the big picture in pharmaceutical systems: pharma regulatory harmonization and convergence; country, global, and donor financing policies; and sustainability strategies. Presents and contrasts different countries regulatory systems for medicines. Introduces the importance of pharmaceutical harmonization convergence/reliance. Addresses selected challenges within the pharmaceutical services delivery framework among under-served and within LMIC populations.

Learning Objectives:

Upon successfully completing this course, students will be able to:

  1. Explain why medicines and related services are crucial to attaining UHC and solving current global health challenges
  2. Identify key concepts such as access to medicines, appropriate use, and how systems to ensure safe, effective, quality-assured and affordable medicines
  3. Apply systems thinking to identify major factors and barriers to access to and appropriate use of medicines and related services and interventions to address them
  4. Define pharmaceutical systems in the context of health systems including key frameworks and metrics
  5. Describe the core components of pharmaceutical financing and illustrate the significance of medicines expenditures both on medical products themselves and on their management to health budgets (e.g., in the context of UHC) and households (e.g., as primary driver of out-of-pocket spending and catastrophic health expenditures)
  6. Identify key elements of various pharmaceutical management information systems (PMIS), including linkage of product and consumer data, and explain how to promote use of data for decision making
  7. Describe key components and scope of pharmaceutical regulatory systems
  8. Explain how National Medicines Regulatory Authorities (NMRAs) and other key regulatory stakeholders ensure safe, effective, and quality-assured medicines within the context of Universal Health Coverage
  9. Describe key principles of pharmacovigilance systems within a regulatory and public health context including risks and opportunities
  10. Identify the merits and challenges of regulatory harmonization, reliance, and cooperation
Methods of Assessment:

Student evaluation based on: (1) Quizzes based on each module – five total (80%); (2) Participation in two LiveTalks (10%), and (3) Self-evaluation for attendance and participation. (10%)

Enrollment Restriction:

Restricted to students in MAS in Global Health Planning and Management

Instructor Consent:

No consent required