Vanessa M completed this course and earned a Pharmuni certificate.
Aggregate Report Writing in Pharmacovigilance
ISO 9001
Quality Management System
Certificate Registration No.: 12 100 60610 TMS
About the Aggregate Report Writing in Pharmacovigilance
Aggregate Report Writing in Pharmacovigilance introduces the advanced knowledge and applied strategies needed to plan, write, and review aggregate safety reports for medicinal products. This course explains how reports such as PSURs, PBRERs, and DSURs support ongoing pharmacovigilance by bringing together safety data over time and helping regulators assess whether a medicine’s benefits continue to outweigh its risks.
You will gain a practical understanding of the foundations of aggregate reporting, the differences between major report types, benefit–risk evaluation methods, regulatory submission planning, and cross-functional coordination. The course explores regional regulatory expectations, data cut-off dates and database lock points, consistency across periodic reports, quality control, and how signal detection findings and regulatory feedback are incorporated into future reporting cycles.
The course focuses on key aspects of aggregate reporting in practice, including:
• The purpose and structure of PSURs, PBRERs, and DSURs
• How to perform and present a structured benefit–risk evaluation
• How to plan submission timelines and coordinate multi-region reporting activities
• How to apply quality control and respond to regulatory feedback in aggregate reporting workflows
Through structured explanations and practical examples, this course helps you understand how high-quality aggregate reports support compliance, transparency, and ongoing benefit–risk evaluation in pharmacovigilance. It is best suited to professionals working in pharmacovigilance, medical writing, regulatory affairs, or related roles who want to strengthen their skills in advanced aggregate reporting.
Through a combination of case studies, skills checks, videos, and visual explanations, this course will guide you step by step toward building the competencies needed for effective aggregate report writing. By the end of this course, learners will be able to:
Learning Objective 1
Differentiate between PSUR, PBRER, and DSUR by comparing their structure, content, and regulatory purpose under EMA, FDA, and ICH guidelines.
Learning Objective 2
Evaluate pharmacovigilance safety data to perform a balanced benefit–risk assessment that meets international regulatory expectations.
Learning Objective 3
Design submission timelines and schedules for EMA, FDA, and PMDA aggregate report requirements, aligning with global regulatory review processes.
Learning Objective 4
Coordinate cross-functional stakeholders (RA, QA, Clinical, PV, Medical Writing) to collect and compile data for pharmacovigilance and regulatory reports.
Learning Objective 5
Apply quality control measures to prevent common errors and compliance issues in aggregate reporting and periodic safety submissions.
Learning Objective 6
Integrate signal detection outcomes into PSURs, PBRERs, and DSURs to create inspection-ready periodic reports.
Learning Objective 7
Revise aggregate reporting strategies in response to EMA/FDA regulatory authority feedback to maintain compliance and improve future submissions.