Periodic safety reports

A medicine's safety is reported to regulators at fixed intervals in aggregate reports: the development safety update report during clinical development, and the periodic safety update report or periodic benefit-risk evaluation report once the medicine is authorised. The parts here divide by what the work on these reports concerns: the format and submission obligations they answer to under ICH, in the EU, the US and other regions, the development safety update report itself, the reports Japan's legislation requires, producing a DSUR and a PBRER to deadline, and what health authorities criticise when they assess a PBRER. What these reports are for beside the risk management plan belongs to the account of the aggregate safety documents across the lifecycle, the safety concerns they carry to risk management, signals in them to case reports and signals, what a vaccine adds to a periodic report to the pharmacovigilance guidance for particular products and populations, the periodic reports for a generic or biosimilar to the pharmacovigilance documents for generics and biosimilars, and a device's periodic safety update report to medical devices.

• What format and submission obligations a periodic report answers to — the ICH E2C(R2) and E2F standards and why the PBRER replaced the PSUR, the EU PSUR's legal basis, aim, content, frequency and central repository, the single assessment of the reports on one active substance, the US periodic adverse drug experience report and how it differs from the PBRER, and the regions that follow ICH, with China's own requirements
• The development safety update report — the annual report on safety during clinical development: what it covers and why it exists, when the first one falls due and how long the requirement lasts, its overlap with post-marketing reporting, the important risks it defines and carries into the risk management plan, the writer's role in it, and the US investigational new drug annual report
• Japan's aggregate safety reports — the periods and deadlines of Japan's five reports, the J-DSUR and the J-PBRER with their Japan-specific elements and the re-examination that sets the J-PBRER's obligation, and the non-serious unexpected periodic report, the infection periodic report and the early post-marketing phase vigilance report specific to Japan
• Producing a DSUR and a PBRER to deadline — how the two reports' periods, deadlines and regional appendices interact, the safety data sources and the agreements for exchanging them between companies, the complexities of the safety data, from database outputs and the type of product to duplicate cases, fatal cases and blinding, the kick-off meeting, team meetings and lessons learned, and the regulatory guidance a writer follows
• What health authorities criticise in periodic benefit-risk evaluation reports — the safety measures an assessment can lead to, the kinds of deficiency in four years of assessment comments and how often each occurs, from the safety assessment and missing information to data inconsistencies and template non-compliance, and the changes to report preparation that address them