Risk Management Plans (RMPs, i.e. a detailed description of the risk management system, please refer to Guideline on Good Pharmacovigilance Practices (GVP) V), originally intended for special risks, are now standard for nearly every type of new marketing authorisation of a medicinal product in Europe. And they are due with every safety relevant variation.
There are really good and really poor RMPs. And as there are also (partially) published RMPs, poor ones do not remain a secret. A not so good RMP will not only receive the regulator’s attention.
Three stumbling blocks:
- Disregarding the definition of the word ‘important’ for your so called safety concerns,
- Ignoring the RMP template and respective guidance,
- Believing that safety concerns have to remain forever.
These stumbling blocks – and others – are avoidable. As are associated superfluous effort, useless measures, and the high cost of maintenance of bloated RMPs.
Each meaningfully utilized hour, when creating the first version of your RMP, saves days, sometimes weeks, of subsequent work. We are happy to suggest which descriptions and measures
- are necessary,
- might be meaningful,
- are ‘nice to have’, or
- are possibly misguided.
We are also available for response to respective regulator assessment reports – or for the follow-up of initiated measures, the description in the next Periodic Safety Update Reports (PSURs), or the RMP update.
Please do not forget: Keeping RMP commitments is one of the ‘key performance indicators’ that you need to monitor as a Qualified Person responsible for Pharmacovigilance (QPPV) (GVP II.B.4.6.).