Objectives of this short course are to:

• Provide an overview of therapeutic risk management tailored to professionals in pharmacoepidemiology, pharmacovigilance, drug utilization review, regulatory, and risk communication;

• Provide details of the requirements of risk management plans, with emphasis on systematic assessments of risk and the effectiveness of risk minimization interventions;

• Introduce methods of program evaluation, including Failure Mode and Effect Analysis; and

• Afford participants an opportunity to explore risk management planning in more depth through a problem-solving workshop.

Introduction and objectives

• Regulatory context for Therapeutic Risk Management in US and EU
• Considerations in developing a risk management plan.
• Critical elements of a plan, including
  • Identifying risks
  • Identifying populations and subpopulations at high risk
  • Determining if risks are preventable
  • Identifying and selecting risk management intervention tools
  • Evaluating the risks
  • Evaluating the effectiveness of the risk management program and tools
• Information sources relating to each plan element
• Examples from risk management programs

Introduction to Program Evaluation and Failure Mode and Effect Analysis
Lucy Savitz, PhD

• Basic concepts of program evaluation
• Process of FMEA
• Methods
• Example from drug safety/medication errors

Workshop for participants to develop an evaluation plan
Judith Jones, MD, PhD, FISPE

Summary and Conclusions
Elizabeth Andrews

• Examples from selected RM programs (Clozaril, Bosentan, Alosetron, Sodium Oxybate)
• Gaps and opportunities
• Key points from the session