Management of Periodic Safety Update Reports (PSURs)

4.5/5
59
PSURs

Duration :

2

1 hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Successful completion provides learners with a dated, traceable and downloadable certificate for the course : 

Each certificate is CPD/CEU accredited and 21 CFR PART 11 compliant. Certificates validity can be checked online through ourย certificate online checker. They can also be shared on Linkedin.

Description:

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 โ€“ Introductory Information & Exposure and Use Patterns

 

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

 

Lesson 3: Format and Content Part 2 โ€“ Significant Findings from Reports and Studies

 

 

Lesson 4: Format and Content Part 3 โ€“ 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

 

 

Glossary

 

Conclusion

 

Quiz

Author:

Ellena Jefferson
Ellena J. Jefferson
Ellena is a CAPA Manager. She serves as a Training and Quality Advisor with ICONIC plc, a global provider for consulting and outsource development in the pharmaceutical industry. She holds a Masters of Science in Research Administration, Magna Cum Laude from the University of Central Florida. Ellena is a fixer who continuously strives for excellence as a way of life; not just as a job.

Reviews:

4.5/5
59
USD: United States (US) dollar ($) ^

$60

Buy now

More than 25 learners ? Request a quote !

This course includes:
One-year access
Updated content every month
Certificate of completion

GxP-Training Benefits

[finale_countdown_timer campaign_id="40465" skip_rules= "yes"]

$60.00 / year

$60.00 / year

We might have this course but it's not displayed online. Please type your email and we will get back to you within 24h

No video yet for this course