ICH guideline
ICH E2C(R2) Q&As: Questions & Answers: Periodic Benefit-Risk Evaluation Report
ICH guideline · Efficacy Guidelines · Step 5
Key facts
| ICH code | E2C(R2) Q&As |
|---|---|
| Title | Questions & Answers: Periodic Benefit-Risk Evaluation Report |
| Guideline series | Efficacy Guidelines |
| ICH step | Step 5 |
| ICH summary (excerpt) | The revision E2C(R2) to E2C has introduced new concepts and principles linked to an evolution of the traditional PSUR from an interval safety report to cumulative benefit-risk report and with a change in focus from individual case reports to more aggregate data evaluation. This supplementary Questions and Answers… |
| File | E2C(R2) Q&As Training Material |
| File type | Video |
| File on ich.org | database.ich.org |
At a glance
- No Full text searchable in Orca1
- E2C(R2) Q&As Training Material Files published by ICH
- None FDA guidance documents based on this guideline
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About ICH guidelines
ICH guidelines harmonise the technical requirements for registering medicines in the ICH regions. Each guideline moves through a five-step process, from concept paper to adoption and implementation by regulators.