European Medicines Agency published Module V of Good Vigilance Practices in 2012 and it was later revised in April 2014. The main objective of this module is to harmonize the development of the Risk Management Plan and its use in the European framework.
A Risk Management Plan is a mandatory report, required by the EMA for all Marketing Authorization Applications and it may be required in any moment during product life-cycle. It is a very complex report that characterizes the safety profile of any medicine, it is an accurate planification of all pharmacovigilance activities, it collects all implemented and planned measures to minimize and mitigate risks and eventually, it evaluates the efectiveness of all these measures.
The proposal of the development of a RMP includes:
• To early identify any risk from all existing information
• To identify areas where there is a lack of information
• To determine future research procedures to identify or characterize risks in a scientific-based approach
• To assure that pharmacovigilance activities start before Marketing Authorization Application and continue during the life-cycle
EMA established a fixed structure that must be followed to develop RMPs that contains defined parts:
I. General Overview of the medicine
II. Safety Specification: It covers all important identified risks, important potential risks, missing information and gaps that must be taken into account for further information
III. Pharmacovigilance plan: to early identify and/or characterize any potential risk
IV. Plan for post-authorisation efficacy studies: Summary figure of planned studies with the agenda and protocols of all drafts should be submitted with the RMP
V. Risk Minimization Measures (Including all activities to assess effectiveness of these measures)
VI. Summary of RMP
In Azierta we have a team of drug safety experts able to prepare any kind of safety report, helping companies to ensure safety and maintain a good risk-benefit ratio of their medicinal products.
Check out our Risk Management Plan presentation on Slideshare or visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.