Risk Management
Plans & Risk Minimization
Duration: 4 weeks (10 hours)
Can be taken individually: Yes
This is one of GPA’s strongest differentiators.
Learning Objectives
Learners will understand how to develop, review, and implement risk management plans and risk minimization measures.
Weekly Topics
Week 1: Introduction to RMPs
Purpose of an RMP
Safety concerns
Important identified risks
Important potential risks
Missing information
Week 2: Pharmacovigilance Plan
Routine PV activities
Additional PV activities
PASS and registries
Canadian-specific considerations
Week 3: Risk Minimization
Routine risk minimization
Additional risk minimization measures
HCP guides
Patient cards
Controlled access programs
Week 4: Evaluation of Effectiveness
Process indicators
Outcome indicators
Surveys
Utilization data
When to modify risk minimization tools
Assessment
Practical assignment: develop a mini-RMP section for a hypothetical product.