PBRERPeriodic Benefit-Risk Evaluation Report (drug safety)
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The workshop, “PSURs, PBRERs, PADERs: Jeepers Peepers - What is all this stuff?” will focus on differences between the various regulatory reports, the issues surrounding which report to submit, and overall need for changes.
Future topics will include the best practices around preparation of aggregate reports such as Periodic Benefit-Risk Evaluation Reports (PBRERs), Periodic Safety Update Reports (PSURs), and Development Safety Update Reports (DSURs), as well as risk management strategies.