Long Description: Appendix F - Mapping Signals and Risks to periodic benefit-risk evaluation report (PBRER) sections

Flowchart with the following options:
Option 1: Safety data from available information sources. Previously recognised risk? No, safety signal detected? No, no further documentation in Periodic Benefit-Risk Evaluation Report (PBRER). Yes, safety signal - Section 15. Closed? No, safety signal ongoing Section 15. Closed? Yes, Section 16.2. Refuted signal. Potential or identified risk. Important? No, action(s) proposed? No, no further documentation in PBRER. Yes, Section 19, consider updated to E2E document, if applicable. Update RSI as appropriate. Important? Yes, Yes, Section 16.4. Key to benefit-risk evaluation? No, action(s) proposed? Yes, Section 18.2. Action(s) proposed? No, no further documentation in PBRER. Yes Section 19, consider update to E2E document, if applicable. Update RSI as appropriate.

Option 2: Previously recognised risk? Yes, new information constituting signal? Yes, safety signal - Section 15. Closed? No, safety signal ongoing Section 15. Yes, Section 16.2. Refuted signal. Potential or identified risk. Important? No, action(s) proposed? No, no further documentation in PBRER. Yes, Section 19, consider updated to E2E document, if applicable. Update RSI as appropriate. Important? Yes, Section 16.4. Key to benefit-risk evaluation? No, action(s) proposed? Yes, Section 18.2. Action(s) proposed? No, no further documentation in PBRER. Yes Section 19, consider update to E2E document, if applicable. Update RSI as appropriate.