Risk management

A marketing authorisation holder sets out in a risk management plan what is known and not known about a medicine's safety, how the remaining questions will be studied and how the risks will be prevented or minimised. This branch covers that plan, and its parts divide by the side of the plan in hand: what the European Union's plan contains, three of its parts taken in depth (the safety concerns it names, the measures that minimise the risks and its public summary), the publication of the full plan, the second revision of its guidance, the writer it asks for and its production from kick-off to approval and across countries, and the United States counterpart, the risk evaluation and mitigation strategy. It leaves what risk management is beside pharmacovigilance and the part patients play in minimising risk to what pharmacovigilance covers, the plan's place beside the development and periodic safety update reports to the three aggregate safety documents across the lifecycle, the periodic reports that carry the same safety concerns to periodic safety reports, the detection and management of signals to case reports and signals, the safety studies a regulator asks for after approval to post-authorisation safety studies, and the plan for a generic or a biosimilar to generics and biosimilars.

• What the EU risk management plan is for and what it contains — the plan's legal standing and purpose, a living and proportionate plan, when it is prepared and updated and what its first version is built from, its origins and adoption, its seven parts and the eight modules of its safety specification, and where its information comes from in the dossier
• Naming and managing the safety concerns — what a safety concern is, identified and potential risks, what makes a risk important and what counts as missing information, the set the second revision of GVP Module V redefined for the plan, whether the periodic report keeps a concern removed from the plan and where the change goes in it, one set of concerns across the regions, and the guidance on safety concerns in the periodic report
• Risk minimisation measures and measuring their effectiveness — routine and additional measures, GVP Module XVI and its revisions, the additional tools and choosing one for its objective, the dissemination plan, evaluating effectiveness, and reporting it in the study documents, the RMP and the PSUR
• Part VI, the public summary of the risk management plan — the summary tables and the lay summary, the public summary's origin and its publication by the agency, how it sits beside the EPAR summary, the package leaflet and the other public documents, its audiences, one text for expert and lay readers in a few hundred words, what the pilot found, and what Revision 2 changed and left open
• Publishing the full plan in the public assessment report — what has been published since October 2023, redacting personal data and commercially confidential information, what counts as confidential and who decides, producing the published version from the approved plan, and the lessons learnt so far
• What Revision 2 of GVP Module V changed — the problems with the first version of the plan that prompted the revision, the consultation and release, risk proportionality and a shorter plan, and converting an existing plan to the new format
• What the plan asks of its writer — the writer's role beyond drafting, from summarising the plan's risks to coordinating the functions behind it, the writer as the expert on its template, what the writer needs to know, keeping the plan consistent with the other safety and dossier documents, and working with the programme team
• Taking the plan from kick-off to approval — the requirement across the authorisation procedures, the five phases from shell document to post-approval, agency review and post-approval in the centralised and the decentralised procedures, and the triggers for an update
• One global plan or several local ones — the plan's place in a first application in several countries, global and local plans, the format a global plan takes, how the versions diverge after submission, drafting ahead of submission, and keeping the plan's writer inside the submission team
• The US risk evaluation and mitigation strategy — the American counterpart the FDA can require for a drug or biologic, its elements from a medication guide and a communication plan to the elements to assure safe use, the burden those elements impose, and the documents it asks for and who prepares them