Aggregate Reporting in Pharmacovigilance

Aggregate Reporting is the safety writing part of Pharmacovigilance. It is considered as one of the niche areas of work within the Pharmacovigilance domain. The focus of Aggregate reports is to fulfil the regulatory requirement by the MAH. Here are some useful tips to start your learning goals to become a successful aggregate report author

  • Understanding Aggregate Report Basics: The foremost requirement is to know the purpose of these reports. It is recommended to start reading the regulatory guidelines to have clear understanding of the subject. GVP module VII & 21CFR314 are the recommended modules.
  • Different Types of Aggregate Reports: There are different types of aggregate reports required by different health authority such as PBRER, PSUR, PADER, Safety Assessment reports, Regional Safety Reports etc. For learning purpose, one must start with the globally accepted reports such as PBRER, PSUR & PADER.
  • Content of the Aggregate Reports: The content and format of Aggregate reports is based on the requirement by the respective Health Authority. Example: PBRER (Periodic Benefit-Risk Evaluation Report) has in total 20 Sections described in GPV module VII however if you see the content of PADER (Periodic Adverse Drug experience report) it has only 4 sections as described in 21CFR314.80.
  • Based on the periodic analysis of worldwide safety reports, product label is updated to optimize safe use of a medicinal product. 
  • Timelines of the Aggregate Reports: The timelines of Aggregate reports are based on the requirement by the respective Health Authority. Example: PBRER (Periodic Benefit-Risk Evaluation Report) within 70 calendar days of the data lock point (day 0) for PSURs covering intervals up to 12 and within 90 calendar days of the data lock point (day 0) for PSURs covering intervals in excess of 12 months. For PADER (Periodic Adverse Drug experience report) it is quarterly for first 3 year followed by Six-Monthly for next 2 years followed by annual reports.

Learning & Understanding Aggregate Reports can help you to get job in this profile that can help to elevate your PV career. Pharmamentors team offers a wide array of solutions for learning Aggregate Reports. The Safety writing program at Pharmamentors is developed keeping in mind the industry requirement and will bridge the knowledge gap. Visit Pharmamentors.in to know more about us.