Pharmacovigilance
Skill packages tagged with “Pharmacovigilance”
ICH E6 Investigator Brochure (IB) Author
Author and maintain ICH E6(R3)-compliant Investigator Brochures for investigational medicinal products, including Reference Safety Information, annual update/change-control summaries, and investigator-facing risk digests aligned with FDA IND, EU CTR, CIOMS V, and ICH E2A expectations.
ICH
E6(R3)
Investigator Brochure
Clinical Trials
GCP
Pharmacovigilance
Regulatory Writing
FDA
EU CTR
RSI
SUSAR
Learn MorePeriodic 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.