Foundations of Safety Case Processing Training Course

Foundations of Safety Case Processing (CP01) is a structured, beginner-friendly introduction to pharmacovigilance, designed to build a clear and practical understanding of how safety cases are managed across the product lifecycle. As accurate safety reporting is critical to patient protection and regulatory compliance, this course provides the essential knowledge required before progressing to hands-on case processing or advanced review activities.

The course introduces the core concepts of adverse event reporting, including key definitions such as adverse events, adverse drug reactions, special situations, and Individual Case Safety Reports (ICSRs). Participants will gain a solid understanding of how safety data is collected, assessed, and reported in both clinical trial and post-authorisation environments, and how these processes differ across settings.

A key focus is the end-to-end safety case workflow, giving learners a clear view of how cases move from initial receipt through to reporting and follow-up. The course also explains the roles and responsibilities of key stakeholders involved in case processing, including sponsors, licence holders, CROs, and regulatory authorities, helping participants understand how different functions interact within a compliant pharmacovigilance system.

In addition, the training explores global regulatory frameworks and reporting timelines, alongside the quality standards expected in safety case handling. Emphasis is placed on the importance of accuracy, consistency, and completeness, as well as common pitfalls and sources of inspection findings.

By the end of the course, participants will have a strong foundational understanding of pharmacovigilance principles, safety case workflows, and regulatory expectations, equipping them with the confidence to support compliant and effective safety case processing in real-world settings.