- AI in PV
- AI Implementation
- AI Training
- AI Compliance
- Regional Coverage
- Expertise
- QPPV Services
- Aggregate Reports
- Signal and Risk Management
- Audits and Due Diligence
- Training and Consultancy
- Digital Transformation
- Technology
A Risk Management Plan (RMP) is a description of the Risk Management system which a Marketing Authorisation Holder (MAH) has put in place for a medicinal product safety and compliance. It is an essential tool in the proactive identification, assessment, and mitigation of the potential risks associated with medicinal products. An RMP is an independent, comprehensive document which is initially submitted as part of a Marketing Authorisation Application (MAA), and then regularly revised by the Marketing Authorization Holder (MAH) throughout the entire lifespan of a medicinal product.
RMPs detail the safety concerns associated with drugs through periodic re-evaluation, or from ongoing post-marketing surveillance, to provide an ongoing understanding of a medicinal product’s benefit-risk safety profile. Their goal is to anticipate possible risks and strategically manage them through Risk Minimization Measures (RMMs) to ensure the highest standards of drug safety.
Identifying the need to create an RMP, or update it.
Organising a Kick-off meeting (KOM) to agree on all due dates and contributors.
The preparation of the RMP, with timelines as agreed in the KOM.
The request and collection of all the relevant data from various sources, including applicable internal departments, following our confirmation/checklist.
The draft RMP based upon our specific template which follows the GVP (Module V) regulatory requirements.
A quality review of the draft RMP by an independent reviewer.
A medical review of the draft RMP by a qualified Safety Physician.
Guidance on appropriate RMMs based on the product’s safety profile.
Our QPPV Office team can create and update RMPs for all types of innovative or generic products that are fully adapted to your specific needs and MAA type. We can do this for products that are or will be marketed inside or outside the EU, drawing on our global partner network together with our world leading Regulatory Intelligence platform iViReg that provides the latest information from over 90 countries.
RMPs require efficient cross-functional collaboration among multiple contributors, and our qualified Safety Physicians provide a full in-depth medical analysis, ensuring that critical area is meticulously covered.
Our approach is focused on transparent communication and thorough planning, identifying and mitigating risks before they escalate. And together with our Risk Minimisation Measures service, we can offer complete, tailored, and integrated Risk Management System.