Signal Detection & Risk Management
Regulatory agencies expect that signal detection and management activities are in place from ‘first in man’ studies onwards, with a process that will evolve in complexity as a product moves through its lifecycle with a growing body of available safety data.
Mapi’s Pharmacovigilance physicians and associated physicians (Medical Directors, Medical Monitors) across Mapi can support signal detection through qualitative review of safety data to identify trends and concerns. We also work with Mapi’s experienced Real World Evidence statisticians to develop quantitative solutions for safety databases to assist with signal detection. Mapi’s Epidemiologists can assist with in-depth evaluation of identified safety trends.
We can host regular cross-functional safety committees with client and Mapi representatives to review periodic and cumulative safety data, to determine if a valid safety signal is present, to propose an appropriate action and communication plan, and to monitor the implementation of said plan.
Risk Management Plans
Risk management plans are requested by regulatory authorities to help identify quality safety data in the post-marketing environment, as well as to identify tools to minimise risk. These include the Risk Management Plan (RMP) format in the European Economic Area and the Risk Evaluation and Mitigation Strategy (REMS) format in the USA.
Mapi is uniquely positioned to assist with the RMP/REMS lifecycle, having access to a diversity of Real World Evidence expertise, including pharmacovigilance, regulatory, epidemiology and Late Phase study expertise. This expertise can support all or a combination of the following:
- Selection of the important risks, pharmacovigilance activities and risk minimization activities to be included in RMP/REMS in collaboration with the client;
- Pre-submission/post-approval meetings with regulatory agencies to negotiate the content of RMP/REMS;
- Medical writing of RMP/REMS documentation, including country-specific adaptions to existing RMP/REMS;
- Implementation of RMP/REMS commitments, including medication guides, educational programmes, controlled distribution programmes, Direct-to-Patient communication, registries (including pregnancy registries), post-approval studies, etc;
- Monitoring effectiveness of risk minimization activities, including conduct of questionnaire-based surveys;
- Redesign of RMP/REMS commitments as product knowledge increases and the regulatory/clinical environment changes;
- RMP/REMS programme closure.