The course covers information on Periodic Safety Update Report/Periodic Benefit Risk Evaluation Report (PSUR/PBRER). Thanks to this course, you will learn what the purpose of this document is and how to prepare PSUR/PBRER. You will go step-by-step through the structure of the PSUR/PBRER and you will get to know what process of PSUR submission and PSUR assessment in European Union look like. Additionally, you will find out information on signal detection in the context of PSUR and you will learn how to calculate PSUR submission frequency. And finally, you will discover the tasks and responsibilities for various institutions involved in the PSUR.
Our products
Management of Periodic Safety Update Report
Language: English 🇬🇧
Total Duration: 88 minutes
69.00€
By attending this course, you will learn
- Key concepts, principles, methods and tools relating to PSUR / PBRER reports
- Key regulations and guidelines for PSUR / PBRER reports (including ICH E2C guidelines)
- Characterisation of PSUR / PBRER reports. You will learn about basic abbreviations for PSUR / PBRER periodic reports
- The main concepts of benefit-risk assessment, risk-based approach
- How to review the main sources of information on adverse effects used for PSUR / PBRER reporting
- The purpose and the structure of PBRER
- How to collect important data needed to prepare PSUR
- Particular sections in PBRER template and how these sections look like
- The roles and responsibilities of different institutions involved in PSUR development
- Types of PSUR assessment procedures- differences by type of product
- Process of PSUR submission, how to assess plan operative aspects and how to manage PSUR submission frequency
- How to assess data in context of signal detection
No reviews yet
