Master the science of drug safety monitoring.

Learn how to collect, assess, report, and prevent adverse drug reactions. This course covers ICSR processing, aggregate reports (PSUR/PBRER, DSUR), signal detection, risk management, literature monitoring, and compliance with global PV regulations.

Build expertise in managing clinical trials.

Understand the fundamentals of clinical trial design, GCP, protocol development, informed consent, ethics committee submissions, site management, monitoring, and study close-out procedures to excel as a clinical research professional.

Transform raw data into reliable results.

Gain hands-on knowledge of CRFs, database design, data entry, validation, query management, medical coding, and data lock. Learn industry standards such as CDISC, SDTM, and tools used for high-quality clinical data delivery.

Navigate global drug approval pathways.

Learn how to prepare, compile, and submit dossiers (CTD/eCTD), manage health-authority queries, handle labeling, variations, and lifecycle management. Master compliance requirements across US, EU, and emerging markets.

Communicate science with clarity and impact.

Develop skills to create regulatory and scientific documents — protocols, investigator brochures, CSRs, safety narratives, manuscripts, and slide decks — with focus on accuracy, structure, and regulatory guidelines.