Risk Management Plan / Risk Evaluation and Mitigation Strategies (REMS)
Risk management plans (RMPs) are increasingly recognized as a key component of the life cycle approach to health product regulation, and are essential to capture real-world patterns of drugs utilization (including side effects and misuse). Particularly, they ensure that the benefits of a drug exceed the risks by the greatest achievable margin for the individual patient and for the target population as a whole. Hence, post-authorization safety studies (PASS), are increasingly conducted as commitments to regulatory agencies.
We have a wide scope of expertise in RMP development using systematic and transparent methods which comply with the International Conference on Harmonization (ICH) standards. We help our clients find and develop appropriate strategies and interventions to ensure the maintenance of a favorable benefit/risk ratio for their product. For example, by enhancing risk communication to healthcare professionals and patients. We also have experience in implementing Risk Evaluation and Mitigation Strategies (REMS) and conducting their effectiveness assessment.
As we work with a global client base, our strategies are tailored to meet country-specific requirements. We have been involved in pre-submission meetings, elaboration of risk management plans, writing of protocols for PASS, conduct of PASS.