Periodic Benefit-Risk Evaluation Report PBRER -With Template

This lecture outlines global principles for pbrer writing: one fiber per active substance, separate pbrers for multiple formulations or fixed-dose combos, and responsibilities and reference safety information.

Explore the PBRER format, core sections and dependencies, and the template guidance for the title page, executive summary, and table of contents.

Explore the structure of the PBRER, from introduction to integrated benefit-risk analysis, including regulatory data, exposure, safety signals, and risk management.

Explore section 5 of the PBRER, detailing estimated exposure and use patterns across clinical trials and post-marketing data, including cumulative exposure and special-population insights from pharmacovigilance.

Learn to draft section 5 of a PBRER, detailing estimated exposure and use patterns through cumulative trial exposure, post-marketing exposure, and methodology using sales data and defined daily dose.

Learn how section 6 data are presented in the PBRER template, including 6.1 MedDRA version, 6.2 cumulative serious adverse events from trials, and 6.3 cumulative and interval post-marketing tabulations.

Draft section seven of the PBRER by detailing significant safety findings from clinical trials, including study titles, numbers, patient enrollment, and interim or long-term results.

Explore section 11 literature, where global and local searches identify new significant safety findings, including unpublished manuscripts, for aggregate reports and icsrs, with attention to class effects and cross-references.

Present lack of efficacy data from controlled clinical trials for products targeting serious or life-threatening diseases, emphasizing data from the clinical team and associated cardiovascular adverse events in section 13.

Discover how section 14 compiles late breaking information after the data lock point, covering clinically significant new publications, follow-up data, safety actions, and label updates.

Explore section 15 of the PBRER, detailing how to classify and present new, ongoing, and closed signals using validated data from pharmacovigilance, ICSR, and literature.

Describe how section 16.2 presents signal evaluation, detailing closed refuted signals and closed confirmed signals, with important and non important risks and a focus on causality.

Characterize risk by compiling cumulative data across trials and post-marketing, using frequency categories from very common to very rare, plus seriousness, risk factors, and mitigation.

Examine how risk minimization measures, including routine product label updates and additional actions like educational materials, are implemented and evaluated for effectiveness in reducing adverse drug reactions.

Section 18 of the PBRER guides integrated benefit-risk analysis for authorized indications, covering medical need, alternatives, and a structured evaluation of benefits, risks, and risk management.

Draft section 18 of the PBRER using sections 16.4 and 17.3 to present medical need, alternatives, and a benefit-risk analysis. Include epidemiological data and real-world evidence to support benefits.

Section 19 of the PBR draws conclusions and planned actions by the marketing authorization holder, evaluating new safety and efficacy information to refine the benefit-risk profile and propose label updates.

Drafts section 19 guidance to evaluate cumulative and interval safety data, confirm a favorable benefit–risk profile, and propose label changes or ARMM measures as needed.

Explain how the EMA uses the PSUSA procedure for medicines, enabling a single assessment by Prac of multiple papers, with preliminary and updated reports, leading to final recommendations.

Learn how post-marketing requirements drive health authority requests in section 15.2 to monitor safety topics, request cumulative analyses of adverse events using IBD data, and update labels and safety studies.