Therapeutic Risk Management

State-of-the-art studies and strategy for global and national programs to measure the effectiveness of risk minimization interventions.

Therapeutic risk management is a field that has expanded and evolved rapidly over the past few years as a result of new regulations. Risk management has become a critical factor for the success of a drug, and requires a close collaboration between key stakeholders, including the pharmaceutical industry, regulatory agencies, healthcare providers and patients.

Examples of Activities:

• Pre- and post-approval risk management planning
• Development, evaluation of and strategies for
  • Risk Management Plans (RMP) and
  • Risk Evaluation and Mitigation Strategies (REMS)
• Effectiveness of Risk Minimization Interventions (RMIs)
  • Failure mode and effect analysis
• Pharmacoepidemiologic and Post Authorization Safety/Efficacy Studies (PASS/PAES)
• Knowledge and understanding (KAU) surveys
• Cohort event monitoring