Certificate Course in Pharmacovigilance Aggregate Reporting

Learn how to structure the periodic benefit risk evaluation report (PBRER) with its three parts, including the title page, executive summary, and a table of contents with about twenty sections.

Present data in summary tabulations of adverse events across clinical trials and post-marketing sources, using MedDRA versions, organized by system organ class, with cumulative and interval tabulations.

Review literature for new safety findings, focusing on pregnancy outcomes, pediatric data, compassionate use, lack of efficacy, overdose, misuse, medication errors, interactions, non-clinical and pk data, with Vancouver references.

Collect section 14 late breaking information that emerges after the data lock point during PCR preparation, including new safety signals, follow-up data, adverse reactions, or updates to product information.

Section 19 finalizes the benefit-risk assessment for each indication, proposes updates to the reference safety information and pharmacovigilance plan, and records PCR conclusions on the summary of product characteristics.

Discover how section 20 of the pharmacovigilance PSR presents appendices, including reference information, tabulations of adverse events from trials and post-marketing data, safety signals, and lists of marketing authorisation holders.

Explain the relation between DSUR and PSUR, noting that some regions accept PCR to meet safety reporting for marketed drugs, with overlapping sections and standalone requirements for each report.

Prepare a single dsur covering all dosage forms, strengths, indications, and patient populations for an active substance, even in co-development or multi-sponsor scenarios; explain missing data in the introduction.

Present a table of contents for pharmacovigilance aggregate reporting, including narrative summaries, MedWatch form 35008 for adverse events not in 15-day reports, and periodic follow-up and reporting formats.