A Risk Management Plan (RMP) is a mandatory document that all Market Authorisation Holders (MAH) need to provide for a new medicinal (and even homeopathic) product so that they can apply to the relevant authority for market authorisation. And it is an aspect of our job that we love. It allows us to get deep into the subject, working with the wider teams who have been involved in the medicine’s journey such as: medics; clinical trials data; labelling; R&D data; investigating any adverse events that occur in pre-clinical settings; and allow us to really get to know the product.
The current guidelines are laid down by the EMA in their Good Pharmacovigilance Practices in Module V – Risk Management systems and in Module XVI – Risk Management Measures: selection of tools and effectiveness indicators.
A Risk Management Plan (RMP) will include:
- a medicine’s safety profile;
- how its risks will be prevented or minimised in patients;
- plans for studies and other activities to gain more knowledge about the safety and efficacy of the medicine;
- measuring the effectiveness of risk-minimisation measures. [Source EMA.Europa.eu]
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