EMA
Skill packages tagged with “EMA”
Clinical Trial Protocol (ICH E6 R3)
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, safety monitoring, IDMC, RBQMS, and regulatory submission requirements (FDA IND / EU CTR 536/2014 via CTIS) for all study phases and therapeutic areas.
EMA CTD Module 1 — Regional Administrative & Prescribing Information
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))
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.