Summary
Marketing authorisation holders are expected to continuously monitor all available data for safety signals and are required to have processes in place to appropriately manage any signals detected. The ways by which companies may meet these expectations vary; what is appropriate for one company may be hugely unrealistic or unnecessary for another. This course covers the regulatory expectations of signal detection and signal management and provides guidance for a structured, scientific approach to signal detection, validation 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 to data mining and AI-supported methods. A range of methods for signal validation and assessment, 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.
Learning Objectives
- Understand the regulatory requirements for signal management in major regions worldwide
- Appreciate the strengths and limitations of different sources and methods for signal detection
- Be able to query EVDAS and understand the outputs
- Know how to validate and adequately prioritise signals for further assessment
- Know how to systematically approach signal assessment to confirm or refute new potential associations and new aspects of known associations
- Discuss requirements and options for communication of signals and management of associated risks
- Understand the links between signal management and other PV system components such as PBRERs, RMPs and PASS
- Realise the place of signal management within the pharmacovigilance system and understand expectations in regard to quality assurance in signal management
- Understand how the signal management system and its outputs are documented, including in the PSMF
- Have a critical understanding of the developing role of AI in signal detection and management
- Design a system for signal detection and management in your organisation that is commensurate to your needs and compliant with regulatory expectations
Who should attend?
Pharmacovigilance executives, group heads and team leaders responsible for implementing and overseeing signal management; Pharmacovigilance personnel conducting signal detection and management; Drug safety physicians; Pharmacoepidemiologists; Pharmacovigilance consultants and service providers; EU QPPVs; Local safety representatives; Pharmacovigilance quality assurance staff; Clinical trial pharmacovigilance personnel and safety data reviewers; Regulatory affairs specialists concerned with maintenance of product information, PBRER production and RMPs
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Digital and LinkedIn certificates
Trainers
Signal Detection and Management in Pharmacovigilance
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
