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