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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.
Lesson 1: What Are Periodic Safety Update Reports (PSUR)?
Lesson 2: Format and Content Part 1 – Introductory Information & Exposure and Use Patterns
Lesson 3: Format and Content Part 2 – Significant Findings from Reports and Studies
Lesson 4: Format and Content Part 3 – Signals and Benefit-Risk Evaluation
Lesson 5: Quality Maintenance and Submission of PSURs
Lesson 6: Assessment of PSURs and Further Action