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
