GMD5005 · Global medicines development: Emerging topics in regulatory science

Overview

This foundational pharmaceutical science course will focus on global regulatory science priorities related to innovation in pharmaceutical product development. You will learn about current research aimed at modernizing toxicology, innovating clinical research and personalized medicine, improving manufacturing and quality, and strengthening social and behavioral science. This graduate-level unit will be taught asynchronously but will include regular touch points with instructors and other students.

Offerings

Assessment

The Handbook does not list a final examination among the assessment items. That is not a guarantee there is none.

In-semester assessment: 100%

Assessment details may change. Please refer to the assessment information in Moodle closer to the start of the teaching period.

Requisites

The Handbook lists no prerequisite, corequisite or prohibition for this unit.

Learning outcomes

1. Define regulatory science
2. Explain the importance of regulatory science research to advance pharmaceutical product development
3. Describe global regulatory science priorities related to innovation in drug development and the challenges they are working to address
4. Identify individuals and organizations that offer innovative strategies to support regulatory aspects of pharmaceutical product development

Workload

Minimum total expected workload to achieve the learning outcomes for this unit is 144 hours per semester typically comprising a mixture of online learning activities and independent study. The unit requires on average 10-12 hours of learning activities per week, including teacher directed learning, independent study and reading time, participation in online discussions, research and preparation for assignments.

Student experience, not official rules. Nothing here changes what the Handbook says.