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Periodic Benefit-Risk Evaluation Reports

Drug Development
Workshop profile:
This workshop is aimed at medical writers with some experience of assessing drug safety information, and a basic understanding of the overall drug regulatory environment. It will also be useful to writers who are familiar with other pharmacovigilance documents such as the Development Safety Update Report but have little or no experience of the requirements for PBRERs in line with GVP Module VII and the revised ICH E2C. For writers with no previous experience of pharmacovigilance documents it is recommended that they attend the foundation workshop “Introduction to Pharmacovigilance Writing” before attending this workshop.
Periodic reports are required by the regulatory authorities to provide updated information on the world-wide safety experience with marketed drugs. Medical writers are increasingly being asked to compile such reports on behalf of pharmacovigilance departments. In July 2012, new pharmacovigilance legislation came into effect across the EU updating the required format and content of a periodic safety update report (PSUR). The document now includes efficacy data as well as safety data and has been retitled the ‘Periodic Benefit-Risk Evaluation Report’ (PBRER). The aim of this workshop is to provide a clear explanation of the requirements of the PBRER in terms of what data need to be included in the document and how they should be presented.
The workshop will briefly discuss the pharmacovigilance requirements for marketed drugs and the place of the PBRER in the drug safety process. It will discuss in detail the content and method of presentation of the different sections of a PBRER in line with GVP Module VII and the revised version of ICH E2C. There will be particular emphasis on the requirements for reporting of benefit-risk evaluation and how the PBRER relates to the DSUR and Risk Management Plan (RMP). Detailed discussion of submission schedules and the submission process will not be covered in this workshop.