Benefit-Risk
Skill packages tagged with “Benefit-Risk”
ISO 14971 Risk File Author
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 above acceptability thresholds without control or justification.
Periodic Benefit-Risk Evaluation Report (PBRER / ICH E2C(R2))
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 for regulatory submission to EMA, FDA (PADER), and other authorities.