# Skills tagged "Benefit-Risk"

2 skills with this tag.

URL: https://rakenne.app/skill-tags/benefit-risk/index.md

- [ISO 14971 Risk File Author](https://rakenne.app/skills/iso14971-risk-file-author/index.md) — Guided elaboration of risk management file for medical devices per ISO 14971: hazard identification, risk analysis, risk control, residual risk acceptability, and benefit–risk rationale. Flags risks …
- [Periodic Benefit-Risk Evaluation Report (PBRER / ICH E2C(R2))](https://rakenne.app/skills/ich-pbrer-pharmacovigilance/index.md) — Draft and validate the Periodic Benefit-Risk Evaluation Report per ICH E2C(R2). Integrates cumulative safety and efficacy data for an authorised medicinal product, producing a benefit-risk evaluation …

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