Risk Management Plans

GVP Module V mandates that a Risk Management Plan (EU-RMP) is prepared for any application for a new marketing authorisation, significant changes to an existing marketing authorisation, in case of safety concerns for a marketed product, and upon request by a competent authority. Content requirements depend on the regulatory status of the product, and have changed significantly with Revision 2 of this GVP Module and the corresponding EU-RMP template. An increasing number of non-EU countries have similar requirements.

In the United States, pursuant to the FDA Amendments Act 2007, submission of a Risk Evaluation and Mitigation Strategy (REMS) may be required when determined necessary to ensure that the benefits of the drug outweigh its risks.

RMPs are complex, extensive documents and their compilation can be a challenging multidisciplinary process. Our organisation can support you in identifying, collecting and assessing the required information, and prepare Risk Management Plans and Risk Evaluation and Mitigation Strategies suitable for regulatory submission in Europe and the United States. Systematic safety risk management planning is a worthwhile activity also during drug development. We offer guidance in systematic safety risk management for your clinical programme.