Regulatory Strategy, Benefit–Risk
& Capstone

Duration: 4 weeks (10 hours)
Can be taken individually: Yes, but recommended after Courses 1–5

Learning Objectives

Learners will integrate PV, risk management, regulatory science, and patient safety into a final applied project.

Weekly Topics

Week 1: Global Regulatory Strategy

• Health Canada, FDA, EMA comparison

• Local affiliate responsibilities

• Global safety governance

• Regulatory communication

Week 2: Benefit–Risk Assessment

• Benefit–risk frameworks

• Safety concerns vs therapeutic benefit

• Risk tolerance

• Regulatory decision-making

Week 3: Safety Communication

• Dear Healthcare Professional Letters

• Product monograph / label changes

• Safety alerts

• Communication with HCPs and patients

Week 4: Capstone Presentations

• Full safety case presentation

• Signal assessment + RMP recommendation

• Benefit–risk conclusion

• Faculty feedback

Final Capstone Project

Students will receive a hypothetical or anonymized product safety scenario and prepare:

• ICSR review summary;

• signal assessment;

• proposed RMP safety concerns;

• risk minimization proposal;

• benefit–risk conclusion;

• short presentation.