وب سایت تخصصی شرکت فرین
دسته بندی دوره ها

Certificate Course in Pharmacovigilance Aggregate Reporting

سرفصل های دوره

Aggregate Report Writing, PSUR, PBRER, DSUR, PADER


1 - General Information
  • 1 - Introduction Purpose of this course and Topics to be covered
  • 2 - Pharmacovigilance Its Objectives
  • 3 - Aggregate Reports and Its Types
  • 4 - Correlation between ICSR Aggregate Reports
  • 5 - Difference between PSUR and PBRER
  • 6 - Basic Terminologies

  • 2 - PBRER Periodic BenefitRisk Evaluation Report
  • 7 - Different Parts of PBRER Part I II III
  • 8 - Section 1 Introduction
  • 9 - Section 2 Worldwide Marketing Approval Status
  • 10 - Section 3 Actions taken in Reporting interval for Safety reasons
  • 11 - Section 4 Changes to RSI
  • 12 - Section 5 Estimated Exposure and Use patterns
  • 13 - Section 6 Data in Summary Tabulations
  • 14 - Section 7 Summary of significant Safety findings from Clinical trials
  • 15 - Section 8 Findings from Noninterventional studies
  • 16 - Section 9 Information from other Clinical trials sources
  • 17 - Section 10 Nonclinical data
  • 18 - Section 11 Literature
  • 19 - Section 12 Other periodic reports
  • 20 - Section 13 LOE in controlled clinical trials
  • 21 - Section 14 Late breaking information
  • 22 - Section 15 Overview of signals New Ongoing or Closed
  • 23 - Section 16 Signal and Risk Evaluation
  • 24 - Section 17 Benefit Evaluation
  • 25 - Section 18 Integrated BR Analysis for approved indications
  • 26 - Section 19 Conclusions and Actions
  • 27 - GVP-Module-VII-Periodic-safety-update-report.pdf
  • 27 - ICH-guideline-E2C.pdf
  • 27 - Section 20 References

  • 3 - DSUR Development Safety Update Report
  • 28 - Introduction Objectives and RSI
  • 29 - General Terminology
  • 30 - Relation of DSUR with PSUR
  • 31 - Single DSUR for an active substance
  • 32 - Periodicity and Data Lock Point
  • 33 - DSURs for Multidrug therapies
  • 34 - E2F-Guideline.pdf
  • 34 - E2F-Presentation-DSUR.pdf
  • 34 - Format and Presentation of DSUR

  • 4 - PADER Periodic Adverse Drug Experience Report
  • 35 - Introduction and Objectives
  • 36 - Frequency and Waiver
  • 37 - Table of Content
  • 38 - Key points while drafting PADER
  • 39 - Differences between PADER and PBRER
  • 39 - uthoring a periodic adverse drug experience reportheres what you need to know.zip

  • 5 - Additional Guidance
  • 40 - Process Flow of Aggregate Reports
  • 41 - How to Switch from ICSR to Aggregate Signal and Risk Management Role

  • 6 - Congratulations
  • 42 - What to do after this training
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    تاریخ انتشار: 18 اسفند 1401
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