20 Elements of Postmarket Reporting: Building Periodic Benefit-Risk Evaluation Reports

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20 Elements of Postmarket Reporting
Building Periodic Benefit-Risk Evaluation Reports

Drugmakers are required to conduct postmarket surveillance activities showing that their products continue to be safe and effective. But the types — formats — and frequency — of the reports mandated can vary.

The final ICH guidance adopted by the FDA in July 2016 lays out the requirements for postmarket surveillance reporting in international markets.

This FDAnews Brief outlines the new guidance, providing detailed information on what each of the 20 modules should contain and how to conduct benefit-risk analysis. It also explains how certain modules can be adapted to meet other regulatory requirements, including ICH’s drug development safety guideline, ICH E2F, and FDA adverse event reporting regulations.

With the 20 Elements of Postmarket Reporting brief you will learn how to prepare Periodic Benefit-Risk Evaluation Reports (PBRER) in a modular format that can be used in other postmarket surveillance reports required by the FDA and international regulators. The 20 modules are:

  1. Introduction
  2. Worldwide Marketing Approval Status
  3. Actions Taken in the Reporting Interval for Safety Reasons
  4. Changes to Reference Safety Information
  5. Estimated Exposure and Use Patterns 5.1 Cumulative Subject Exposure in Clinical Trials
  6. Data in Summary Tabulations
  7. Summaries of Significant Findings from Clinical Trials during the Reporting Period
  8. Findings From Non-Interventional Studies
  9. Information From Other Clinical Trials and Sources
  10. Nonclinical Data
  11. Literature
  12. Other Periodic Reports
  13. Lack of Efficacy in Controlled Clinical Trials
  14. Late-Breaking Information
  15. Overview of Signals: New, Ongoing, or Closed
  16. Signal and Risk Evaluation
  17. Benefit Evaluation
  18. Integrated Benefit-Risk Analysis for Approved Indications
  19. Conclusions and Actions
  20. Appendices

You will learn:

  • How PBRERs differ from the previously required Periodic Safety Update Reports
  • How to incorporate core data sheets into PBRERs
  • The importance of International Birth Dates and Data Lock Points
  • How to coordinate the frequency of individual postmarket reports required by various regulatory agencies
  • Which elements of a PBRER can be used in other postmarket reports
  • Differing interpretations of the words “efficacy” and “effectiveness”
  • The meaning of the terms “key risk” and “key benefit”

Use this 20-element plan to ensure you conduct postmarket surveillance activities that show that your products are safe and effective.

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Who Will Benefit

  • Regulatory affairs
  • Research and development
  • Postmarket surveillance staff
  • Clinical researchers

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