1. The Risk Management Plan (RMP)

1.3. The Pharmacovigilance plan

The pharmacovigilance plan proposes activities to better characterise and assess the risks during the lifecycle of a medicine. (e.g., to investigate frequency, severity, seriousness and outcome of a risk under normal conditions of use, and/or which populations are particularly at risk).

These pharmacovigilance activities can be categorised as:

Routine activities, also known as ‘passive surveillance’:

  • Spontaneous adverse event reports are analysed by the MAH and regulatory authorities. The results are recorded in the European Pharmacovigilance database –part of EudraVigilance, and other in-house and international databases.
  • Periodic Safety Update Reports (PSURs) are compiled by the MAH from event reports over a specific time period (usually since the compilation of the last PSUR, please refer to the following webpage for more information https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/periodic-safety-update-reports-psurs) and include a reassessment of the benefit-risk balance. PSURs are submitted to the regulatory authorities.
  • Data from different databases is routinely analysed to identify signals between adverse events over longer time periods. This activity is known as ‘data mining’.

 Additional activities are numerous and specific to each medicine’s safety profile. They may include:

  • Non-clinical studies: including studies to better understand the mechanism of toxicity.
  • Pharmacogenetic studies: i.e., investigating how genetic variations may impact how someone responds to a treatment.
  • Stimulated report: using a specific process for adverse event reporting that stimulates healthcare professionals and patients to report adverse events (example: reporting can be stimulated by invitation from patients’ or consumers’ organisations to their members, or a class lawsuit).
  • Active surveillance: a proactive and organised monitoring of the use of the medicine to better assess the number of adverse events in a given population, e.g. pregnancy follow-up. This could occur in doctor’s practices or hospitals involved in the risk monitoring, patient registries, electronic record research, etc.
  • Non-interventional/observational studies: such as prospective (cohort), cross-sectional (survey) and retrospective (case-control) studies. For more information, please refer to Course 2 Lesson 3.
  • Clinical trials: additional clinical trials may be required to investigate particular risks. For more information on a post-authorisation safety study (PASS), please refer to Course 3 Lesson 1.
  • Medicine utilisation studies: studies that aim to monitor medicine usage.