Management of Periodic Safety Update Reports

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Duration :

2

hour(s)

Skill level:

Regulatory

Language:

English

Final exam:

Yes

Certificate of Completion:

Yes

CEU / CPD Accreditation:

Yes

Certification:

Gain a recognized and traceable certificate after completing the course :Β 

All our certificates are unique, authentic, CPD/CEU accredited, and FDA 21 CFR PART 11 compliant. Certificates validity can be checked online through our certificate online checker.

Description:

The data obtained from the use of a novel drug substance in a clinical trial is limited at best. Following the approval of the drug medication for marketing, it will be released into a more heterogenous population outside the controlled setting of clinical trials. It is necessary for the safety of the medication to be monitored at this stage also and this is done using Periodic Safety Update Reports (PSURs). These document the safety profile and efficacy of the medication from it’s development and us updated progressively. This course shows the format and content for such reports and the roles played by the EMA and the FDA in ensuring the safety of the population through the enforcement of proper safety update reporting.

 

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

 

 

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

Author:

avatar-8efb6af3906540a366a8e62f453f85f9-1024x1024
Ellena J. Jefferson
Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON 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.”Ellena is a CAPA Manager at Janssen Pharmaceuticals where she serves as a Training and Quality Advisor with ICON 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.

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