Effective safety signal detection and management incorporates pharmacovigilance, information technology, medical, regulatory, and governance activities. Biopharmaceutical sponsors are expected to identify safety issues via analysis of all information available to them. As the amount of data has grown, so have tools and strategies to manage safety signals. Each data source and analytic strategy has inherent strengths and limitations. An understanding of these factors is a prerequisite for an effective system of signal triage, prioritization, evaluation and decision-making. The course will present signal detection and management in the framework of regulatory compliance as well as risk management and risk communication strategies. Outputs from signal detection systems will be the basis for hands-on exercises and discussion.
Course Level: Advanced
What You Will Learn
- How data mining fits into an overall system of product safety risk management.
- How to read and interpret outputs from automated data mining analyses.
- How to prioritize and evaluate signals from data mining.
- Create an efficient, multidisciplinary process for signal detection and management that meets regulatory standards.
Who Should Attend
This course is designed for members of clinical safety and pharmacovigilance organizations who oversee, manage, or perform signal detection activities. The course will also benefit participants who make risk management decisions based on signal detection including professionals who work in:
- Clinical safety and pharmacovigilance
- Regulatory affairs
- Benefit-risk management
- Information technology supporting pharmacovigilance activities
At the conclusion of this course, participants should be able to:
- Lead the implementation of an integrated signal detection and management project
- Identify strengths and limitations of specific data sources for signal detection and evaluation.
- Interpret outputs from automated quantitative signal detection methods (data mining results).
- Set up triage and prioritization procedures for potential safety signals.
- Apply structured medical assessment to safety signal evaluation.
- Design governance processes for signal escalation, decision-making, action and communication.
- Implement a safety signal tracking system.
- Integrate safety signal management into overall risk management