Risk Minimization Interventions (RMIs)
At the time product launch, a sponsor/Market Authorization Holder needs to evaluate whether additional risk minimization activities beyond routine ones are warranted. Additional risk minimization strategies may include restricted distribution, communications to the patients, healthcare providers as well as implementing training programs for head office staff and sales force.
Consistent with requirements across various regulatory agencies, we develop post-authorization safety studies (PASS) aiming to evaluate the effectiveness of risk minimization interventions (RMIs). As Prof. Moride was co-author of the CIOMS working group IX on the “Practical Approaches to Risk Minimisation for Medicinal Products”, we are well prepared to apply best practices.
Our capabilities include design and implementation of:
- Drug utilization studies (DUS), which are non-interventional using healthcare databases or historical cohort studies with ad hoc data collection, aiming to evaluate appropriateness of drug utilization patterns
- Prescriber knowledge and understanding surveys (KAUs), which assess prescribing behaviors and knowledge of risks. Such tools can be used to determine whether communication tools or other risk minimization strategies are effective.
- Studies to measure the burden of risk minimization.