Pharmacovigilance – Aggregate Reporting

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Pharmacovigilance – Aggregate Reporting

Our industry experts have designed an advanced training of 30 days in “Aggregate Reporting in Pharmacovigilance.” This training program provides an exceptional online live learning experience with complete demonstration and preparation of aggregate reports (DSUR, PBRER/PSUR, and PADER). Aggregate report writing gives a platform to the professionals to outshine in their pharmacovigilance profession.


With the help of our industry experts we have created the best curriculum of understanding aggregate reporting and the important aspects of the same.

Introduction to aggregate reporting in pharmacovigilance.

  • What is aggregate Report Writing?
  • Main objectives of Aggregate Reports.
  • Types of Aggregate Reports.
  • Guidance and Regulations related to Aggregate Reports.
  • Difference Between Various Aggregate reports.
  • Performance evaluations.

Technical aspects of aggregate report.

  • The terminology used in Aggregate Reports.
  • Style Guides.
  • Reporting Timelines of Various Aggregate Reports.
  • Performance evaluations.

Development safety update (DSUR)

  • Guidelines.
  • Template.
  • Practical.
  • Performance evaluations.

Post marketing periodic safety update report (PSUR) and periodic benefit-risk evaluation reports (PBRER)

  • Guidelines.
  • Template.
  • Practica.
  • Performance evaluations.

Periodic adverse drug experience report (PADER/PAER)

  • Guidelines.
  • Template.
  • Practica.
  • Final assessments.

Training aftermath

Towards the end of this training, you will be able to:

  • Define the main principles in the ICH GCP, CIOMS, and GVP guidelines related to aggregate reporting.
  • Author and review the content and data presentation in aggregate reports.
  • Understand the key challenges in the aggregate report sections in addressing them.
  • Understand the procedure and timelines of aggregate report submission.
  • Handling regulatory communications regarding aggregate reports with Regulatory Authorities.
  • Finding out critical Inspection findings in aggregate reports.

Irreplaceable Aspects

We are known as the finest biopharmaceutical solution provider because we provide:

  • Cost-effective courses.
  • Training as per global standards.
  • Execution through transparency.

If you are interested in initiating a career in Pharmacovigilance and document the best and reliable aggregate reports we are here to assist you through the process

Download the course pdf for a detailed understanding before you begin your Pharmacovigilance Reporting with us!