Updated for 2020: A Practical Approach to Risk Management Plans

Writing a risk management plan (RMP) for the first time can be a daunting task. The RMP is a legally binding regulatory document submitted to health authorities and is a mandatory commitment for all Marketing Authorisation Holders in the European Union. The goal of the RMP is to improve the benefit-risk balance of a medicinal product by combining risk assessment and risk minimisation. The RMP is a complex document, but with the revised RMP module (March 2017), comes the revised EU template for RMPs (rev 2 format) and the RMP is now structured in a clear manner with less repetition and with attention to detail. Due to the complexity of the RMP, writing one usually consists of a multidisciplinary team (e.g. toxicologists, pharmacologists, pharmacovigilance, clinical and regulatory experts), who will advise on the evaluation of risks and the proposed measures for prevention and risk minimisation. For someone with experience in clinical report writing and who enjoys this side of Pharmacovigilance, preparing an RMP can be a rewarding challenge! Here, we will aim to address some frequently asked questions and discuss some useful steps to consider before starting to write an RMP. The RMP can cause some level of confusion particularly in relation to the legal requirements and preparation. Some of the frequently asked questions we receive from our clients include:

• Do I need an RMP if my product has been on the market for a very long time? The RMP aims to be proactive, as opposed to a reactive with regards to the consideration of risks. As knowledge regarding a medicinal product’s safety profile increases over time, so will the risk management plan change.
• How often is an RMP update required? The RMP is a dynamic document that should be updated throughout the life cycle of the product(s). This includes the addition of safety concerns, where required, but also, as the safety profile is further characterised, the removal or reclassification of safety concerns or if there is a significant change in the existing additional pharmacovigilance or additional risk minimisation activities.
• How shall I present a Risk Management Plan? Guidance on the format and content of the RMP as outlined in the EMA`s Guideline on good pharmacovigilance practices, Module V, the RMP template (currently Rev 2) is available in the Pharmacovigilance section of the Agency’s website. The submitted RMP should follow the RMP template and guidance with regards to the risk categorisations (identified, potential, important).

Prior to starting a Risk Management Plan consider the following:

Firstly, get yourself acquainted with the formal requirements for content and submission of EURMPs as outlined in Good Pharmacovigilance Practices (GVP) Module V published by the European Medicines Agency (EMA). Secondly, consider whether RMPs are available for products with the same active substance. In the case of a generic drug, check if RMPs exist for the innovator, the reference product, or a generic. The RMP for a generic should comply with the RMP for the reference product, unless some safety concerns are clearly no longer relevant. Finally, ensure that each risk is assessed thoroughly and if necessary, the appropriate risk minimisation tools are used to enhance the benefit/risk balance of the medicinal product. The EMA provides guidance on risk minimisation measures in their Good Pharmacovigilance Practices in Module V – Risk management systems and also in Module XVI – Risk minimisation measures: selection of tools and effectiveness indicators. The most common types of risk minimisation tools are educational programmes, controlled access programmes and pregnancy prevention programmes. Other types of safety communications, such as Direct Healthcare Professional Communications (DHPCs), are sometimes used as risk minimisation measures, in order to communicate a safety issue to practitioners, patients, or carers.

We Can Help with Your RMP

If you require assistance in undertaking a Risk Management Plan, we can assist you.  Our Medical & Pharmacovigilance team has extensive experience in the sector.  Contact us on 00353 52 61 76 706 or complete the form below and we will get back to you. [ninja_form id=1]

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Download Our Clinical Trials E-Book

Acorn Regulatory is a leading regulatory, pharmacovigilance and clinical consultancy company headquartered in Ireland.  Our Clinical & Medical team works with the largest and the leading companies in life sciences to assist them in bringing their products to market.  The team, led by Dr. Danica Cvetkovic, has written extensively on the issue.  In the latest e-book from Acorn Regulatory, we look at the best and most popular articles from our Clinical & Medical team. Download the e-book here. References:

1. S Götsch A shot at demystifying the risk management plan for medical writers, Medical Writing 2015 VOL. 24 NO. 2
2. Guideline on good pharmacovigilance practices GVP Module V – Risk management systems (Rev 2)
3. Guideline on good pharmacovigilance practices Module XVI– Risk minimisation measures: selection of tools and effectiveness indicators