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.

Outline the introduction section of the PCR, including product overview, international birth date, reporting interval, therapeutic class, mechanism of action, indications, dosage forms, and exchange agreements.

Document worldwide marketing authorization status by detailing first authorization date, indications, dose and dosage form, and country approvals, with data organized in an appendix.

Section 3 outlines actions taken for safety in the reporting interval, detailing regulatory actions for investigational use and marketing experience that influence risk-benefit balance and clinical development.

identify and document significant changes to the reference safety information in section four, including contraindications, warnings, adverse reactions, interactions, and trial findings, sourced from regulatory affairs during kickoff.

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.

Summarizes clinically important efficacy and safety findings from trials during the reporting interval, with data by sex, age, indication, dose, and region, across completed and ongoing studies.

Present safety findings from non interventional studies, including observational, epidemiological, registry, and active surveillance data, and provide an appendix detailing sponsor studies and essential study information.

Summarize information from other clinical trials and sources to support benefit risk assessments (section 9.1) and evaluate medication error patterns (section 9.2) using tabular safety data.

Summarize nonclinical data in section ten, including in vivo and in vitro safety findings from carcinogenicity, reproduction, and immunotoxicity studies, and discuss PSR implications using Veeva or RIM SharePoint data.

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.

Review section 12 to capture other periodic reports for fixed combination products or multiple indications, summarizing significant safety findings from partner reports and reports from sponsors or MAHs.

Examine Section 13's focus on lack of efficacy in controlled clinical trials and its implications for benefit-risk evaluation of therapies for serious illnesses. Highlight data sources and example adverse events.

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.

Explore section 15 of pharmacovigilance aggregate reporting, detailing new, ongoing, and closed signals during a defined review period. Learn qualitative and quantitative analyses, tabular reporting, signal sources, and actions taken.

Dive into section 16 of pharmacovigilance aggregate reporting, evaluating signals, safety concerns, and identified or potential risks, with emphasis on the reporting interval, data sources, and risk minimisation.

Explore section 17 of pharmacovigilance aggregate reporting, detailing baseline and newly identified efficacy and effectiveness information. Learn how these data feed the integrated benefit–risk analysis.

Integrate benefit and risk by synthesizing the prior risk calculation and benefit evaluation to assess the overall performance of the product in approved indications.

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.

Understand the development safety update (DSU) as the annual safety review for drugs under development or with ongoing studies, guided by reference safety information (RSI) and US/EU reporting requirements.

Explore essential pharmacovigilance terminology, including data cutoff (DLP), birth dates (IBT/IBD), identified risk, potential risk, and signal in aggregate reporting.

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.

Describe periodicity and data lock point in dsr reporting, using development international birth date to set the annual period for dslr, and submit within 60 days after lock point.

Explore strategies for DSUR preparation in multidrug therapy trials, outlining when to compile single vs multiple DSURs and how to include data on investigational and marketed drugs.

Learn the dsur format in pharmacovigilance aggregate reporting, including the title page, executive summary, and a 20-section table of contents covering safety data and cumulative exposure.

Explain the periodic adverse drug experience report, an aggregate safety submission to the US FDA, to update post-approval information and assess the medicine’s global safety and benefit-risk profile.

Submit quarterly reports for the first three years after US drug approval, then annual submissions; the marketing authorization holder may obtain an FDA waiver and submit PCR or paper.

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.

Draft PADERs by ensuring all 15 day reports are submitted in the safety database, emphasize expedited cases with clinical significance, include CAPA actions, and attach the USP with updates.

Bader presents individual case narratives for serious events for US FDA submission under 21 CFR 314.80, while Faber offers a broader EU and global benefit risk analysis with more sections.

Schedule a kickoff meeting tied to the EU reference date list, appoint an aggregate report coordinator, and gather stakeholder inputs to map draft-to-submission timelines for the report.

Learn to switch from ICSR to aggregate reporting, signal and risk management roles by studying EMA good pharmacovigilance guidelines, preparing theoretically, and pursuing internal opportunities.

Complete this pharmacovigilance aggregate reporting course and download your completion certificate, then share it on LinkedIn to inspire others; access resources and explore further courses to advance your pharmacovigilance skills.