Robust signal detection and management is the backbone of any pharmacovigilance system. Marketing authorisation holders are expected to continuously monitor all available data for safety signals and are required to have processes in place to evaluate such signals and take appropriate action. The ways by which companies may meet these expectations vary; what is suitable for one company may be hugely unrealistic or unnecessary for another. This course covers the regulatory expectations of signal detection and management and provides guidance for a structured, scientific approach to signal detection, validation, prioritisation and assessment. Through presentations, case studies, discussions and exercises, participants will obtain a critical understanding of the potential sources and methods for signal detection, ranging from single ICSRs and case series to data mining and AI-supported approaches. Methods for signal evaluation, including tools for assessment of causality and benefit-risk impact will be examined. Options and requirements for communication of confirmed signals and mitigation of new risks will be discussed. Finally, participants will learn about the interfaces of signal management with other PV system components such as PBRERs and RMPs, gain a quality system perspective of signal management, and explore how effective and compliant signal management can be implemented in their own organisation.

The course is in line with relevant regulatory guidelines such as EMA GVP, FDA Guidance for Industry, ICH and CIOMS.