概要

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. This advanced level 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 practical exercises and discussions. Learn about the new sponsor obligations for signal detection in EudraVigilance based on updates to GVP Module IX.

New to Signal Detection? We recommend one of the following online courses to learn the basics prior to attending this advanced course.

Can't attend this course? Join us in September in Washington DC!

何を学ぶか

Create an efficient, compliant, multidisciplinary process for signal detection and management
Integrate data mining within an overall system of product safety risk management
Read and interpret outputs from automated data mining analyses
Prioritize and evaluate signals from all sources (including data mining)
Discuss how regulatory authorities use data monitor product safety from clinical development to post-marketing
Discuss new sponsor obligations for signal detection in EudraVigilance based on updates to GVP Module IX

参加対象

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
Pharmacoepidemiology
Regulatory affairs
Benefit-risk management
Information technology supporting pharmacovigilance activities

学習目的

At the conclusion of this course, participants should be able to:

Lead the implementation of an integrated signal detection and management project
Recognize the advantages of various data visualization tools
Identify strengths and limitations of specific data sources and methods for signal detection and evaluation
Interpret outputs from automated quantitative signal detection methods (data mining results)
Discuss setting up triage and prioritization procedures for safety signals
Apply structured medical assessment to safety signal evaluation
Design governance processes for signal escalation, decision-making, action and communication
Integrate safety signal management into overall risk management

Digital Learning Catalog

Download

Advanced Signal Detection - Tools, Triage, Evaluation, and Escalation

概要

何を学ぶか

参加対象

学習目的

Digital Learning Catalog

最新情報や機会を逃さないで