Management of Periodic Safety Update Reports (PSURs)

The safety management of approved drugs and medical devices is a crucial component of pharmacovigilance. Once a drug or medical device transitions from the controlled environment of clinical trials to the diverse real-world conditions, Periodic Safety Update Reports (PSURs) become a pivotal tool in monitoring and evaluating the risk-benefit balance.

Our certified and CPD / CEU accredited course, “Management of Periodic Safety Update Reports (PSURs)”, takes you through the structure and content of these key pharmacovigilance documents. It emphasizes the important roles of regulatory bodies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in promoting public safety through rigorous safety update reporting.

This course offers an interactive online learning experience, synthesizing the key aspects of PSUR management. Developed by a team of Regulatory Affairs Experts with qualifications from Northeastern University, Boston, the course content is curated by a Senior Member who effectively bridges theory with real-world application.

Join us to delve into the intricacies of PSURs within the broader scope of pharmacovigilance, equipping yourself with the knowledge to enhance the safety, effectiveness, and market success of your products. Not only does this course enable you to understand and implement PSURs more effectively, but it also helps to elevate your professional standing through its globally recognized certification and CPD / CEU accreditation.

Curriculum

Introduction

Lesson 1: What Are Periodic Safety Update Reports (PSUR)?

• Why are PSURs Needed?
• Guiding Principles for Benefit-Risk Evaluation
• Principles for Preparing PSURs
• What Are the Contents of PSUR?

Lesson 2: Format and Content Part 1 – Introductory Information & Exposure and Use Patterns

• Introductory Information
• Exposure in Clinical Trials
• Exposure from Marketing Experience

Lesson 3: Format and Content Part 2 – Significant Findings from Reports and Studies

• Summary of Adverse Events
• Clinical Trial Findings During the Reporting Interval
• Findings from Non-Interventional Studies
• Other Sources

Lesson 4: Format and Content Part 3 – Signals and Benefit-Risk Evaluation

• Signals
• Risk Characterization
• Benefit Evaluation
• Benefit-Risk Analysis
• Conclusion and Appendices

Lesson 5: Quality Maintenance and Submission of PSURs

• Maintaining Quality
• Frequency of Submission
• Special Submission Requirements

Lesson 6: Assessment of PSURs and Further Action

• Who Performs the Assessment?
• Risk Management Plan and Risk Minimization
• More on Product Modification

Glossary

Conclusion

Quiz