EMA
Skill packages tagged with “EMA”
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.