Pharmacovigilance Services
                                     Mark Waring

Safety risk management

Safety risk management

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, 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 can be complex, extensive documents and their compilation can be a challenging multidisciplinary process. We 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.

We can help you with the preparation of targeted questionnaires, support the conceptualisation and planning of pharmacoepidemiological activities that might help you better understand the safety profiles of your products, help you decide  which additional risk minimisation tools might optimise patient safety, and support you with the design of such tools and the identification of suitable service providers.

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.

Case study


The challenge: An EU-RMP is required for a niche product in a neurology indication. The client is unsure what topics constitute ‘safety concerns’ and how their characteristics and management should be described.

Our contribution: Mark Waring Pharmacovigilance Services holds a structured workshop with the client’s project team to determine the safety concerns and agree on their management. Building on the workshop results, we draft the RMP within the agreed timelines.

The outcome: Upon regulatory submission, the proposed risk management activities are considered acceptable.