1. Section 1 Introduction
2. Section 2 Worldwide marketing authorization status
3. Section 3 Part I Actions taken in the reporting interval for safety reasons
4. Section 3 PART II Actions taken in the reporting interval for safety reasons
5. Section 4 Changes to reference safety information
6. Section 5 Estimated exposure and use patterns
7. Template- Section 5 Estimated exposure and use patterns
8. Section 6 Data in summary tabulations
9. Template, Appendix 2A, 2B for Section 6 Data in summary tabulations
10. Section 7 Summaries of significant findings from clinical trials
11. Template- Section 7 Summaries of significant findings from clinical trials
12. Section 8 Findings from non-interventional studies
13. Section 9 Information from other clinical trials and sources
14. Section 10 Non-clinical data
15. Section 11 Literature
16. Section 12 Other periodic reports
17. Section 13 Lack of efficacy in controlled clinical trials
18. Section 14 Late-breaking information
19. Signal Management Overview
20. Section 15 Overview of signals new, ongoing, or closed
21. Flow Chart - Signal & Risk Presentation
22. PBRER Template for draft guidance to Section 15 -Overview of Signals
23. Section 16 Signal and risk evaluation
24. 16.1 Summary of safety concerns
25. 16.2 Signal Evaluation
26. Section 16.3 Evaluation of risks and new information
27. Section 16.4 Risk Characterisation
28. Section 16.5 Effectiveness of risk management
29. PBRER Template for draft guidance to Section 16 Signal and Risk Evaluation
30. Section 17 Benefit Evaluation
31. PBRER Template for Section 17 Draft guidance
32. Section 18 Integrated benefit-risk analysis for authorised indications
33. PBRER Template guidance for Section 18
34. Section 19 Conclusions and actions
35. PBRER Template for Section 19 draft Guidance
36. References and Appendices
37. Learning Evaluation 3.html
