Pharmacovigilance Risk Management - Overview
Risk Evaluation and Mitigation Strategies (REMS) and Risk Management Plans in Pharmacovigilance (RMP PV) guide identifying, monitoring, and minimizing patient risks. They differ in elements such as the implementation of risk management pharmacovigilance plans and the reporting-time requirements.
The EU RMPs
The EU risk management plan in pharmacovigilance is a more comprehensive and extensive safety package that the sponsor is obligated to follow throughout the lifecycle of all new drugs or biologics. The main components of this plan include developing the ideal risk mitigation strategies, (which are mainly associated with the Summary of Product Characteristics (SmPC) and PL).
A risk management plan is required for a new marketing application in the EU. It is provided to RAs as one of the documents to be completed before the Marketing Authorization Application (MAA) is submitted because it can only be finalized when the SmPC is final. The risk management plan in pharmacovigilance aims to describe the safety profile of the drug, i.e., the potential risks and missing information.
Risk management is an ongoing activity that involves updating the RMP and implementing or responding to comments from Regulatory assessors. Freyr, a leading provider of comprehensive pharmacovigilance services, extends several of its offerings to global pharma companies.
Risk Evaluation and Mitigation Strategies (REMS)
The US REMS deals with risk communication, which consists of components such as a medication guide, a communication plan, elements to ensure safe use, an implementation system, and a timetable for the submission of assessments. The US REMS is compulsory for some medicines only.
REMS programs can be designed for a single drug safety risk evaluation and mitigation plan or a class of drugs. Each REMS has specific safety measures unique to the risks associated with a particular drug or class of drugs.
Pharmacovigilance Risk Management
- Develop strategic and tactical plans to characterize and quantify safety concerns and minimize risks to patients.
- Provide support throughout the submission process.
- Customize risk management and pharmacovigilance strategies to local requirements.
- Implementation of additional pharmacovigilance activities and risk minimization measures, including Post-authorization Safety Studies (PASS) such as observational studies and registries, creation of targeted questionnaires, and designing and implementing educational materials for pharmacovigilance risk management reporting.
- Design and implement interventions or studies that align with risk management pharmacovigilance and data collection objectives, and effectively implement these actions or studies in the post-marketing world.
- Revise and update the risk management pharmacovigilance document, if warranted, as an outcome of the effectiveness evaluation.
- Evaluation of the requirements for REMS if the request is received from the FDA.
- Preparation of the key elements of REMS like the Medication Guide or Patient Package Insert, Communication Plan, Elements to Assure Safe Use (ETASU), and the Implementation System.
- Inclusion of the timetable for assessment of the REMS.
- Preparation of the required documents as per the REMS program meetings.
- Preparation/compilation of REMS reports as per the REMS program meetings.
- Sharing information regarding the REMS program meetings as per the agreed time intervals, as and when required.
- Handling queries/issues related to the REMS data as per the REMs program meetings.
- Provide continuous support until REMS approval.
- Providing further assistance on updates/feedback shared by the FDA.
- Helping in the Single Shared System (SSS).
- Support in filing NDA/ANDAs.
- Preparing single REMS documents, REMS materials (except MGs), and supporting documents.
- Shared database and infrastructure.
