# Skills tagged "EMA"

3 skills with this tag.

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

- [Clinical Trial Protocol (ICH E6 R3)](https://rakenne.app/skills/clinical-trial-protocol/index.md) — Draft clinical trial protocols compliant with ICH E6(R3) and ICH E8(R1). Covers study design, objectives, endpoints, eligibility criteria, estimand framework (ICH E9(R1)), statistical analysis plan, …
- [EMA CTD Module 1 — Regional Administrative & Prescribing Information](https://rakenne.app/skills/ema-ctd-module1-application/index.md) — Draft and validate EU Module 1 of the Common Technical Document for MAA: application form, SmPC, PIL, labelling, and environmental risk assessment per EU requirements.
- [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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