概览

This virtual live training course covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' function and their organisation, including the data mining techniques for large volume ADR data analysis.

The entire course is in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management (rev. 1), Commission Implementing Regulation (EU) No. 520/2012, CIOMS VIII and relevant EMA guidelines.

This training is primarily developed based on EU legislation, but it also covers regulatory expectations for signal management in the US, Switzerland, Canada, Australia, and few other countries.

Participants benefit from the hands-on experience of trainers who have worked for many years in signalling activities and are ready to not only explain the legislation, but also provide personal experience and most commonly followed practices that are often considered as industry standards.

What participants from previous course say about the faculty:

"With very good knowledge of the topics covered, adequacy in the answers to all questions, with very good presentation skills and the ability to arouse interest and hold attention!"

精选主题

Signal Detection – Theory, methods, and data mining

Practical exercise on signal detection – analyse and discuss an article
Practical exercise on data mining methods – how to calculate RRR, ROR, PRR

Signal Management – Detection, validation, confirmation, analysis and prioritisation, assessment, and recommendation for action

Signaling exercise in PSUR review – data visualisation and analysis

Regulatory expectations in the EU, US, Switzerland, Canada, Australia etc.

Exercise on signal management – manage information from PRAC

EVDAS introduction and implementation in signal management
Strategy for implementation of signal management process in your own organisation (covering both small and large companies)

Exercise on signal management processes – propose and discuss the most appropriate signal management procedure for various types of organisations

谁应该参加？

This virtual live training course is designed for professionals working in:

Pharmacovigilance (including EU QPPVs)
Drug Safety and Risk Management
Signal Management and Safety Science
Pharmacoepidemiology
Information Technology
Pharmacovigilance Consultancies and Service Providers
Quality and Compliance

Course level: Intermediate, for professionals with 2-3 years (or more) of experience in Pharmacovigilance, or related functions who are working in PV around signal management.

学习目标

After the completion of this virtual live training course, participants will be able to:

Apply the essential concepts and principles of signal management in PV and implement or improve this process in their own organisation

Compare different approaches to signal management that are followed by various organisations

Implement EVDAS into signal management process

Identify the regulatory expectations at different geographic regions

Learning objectives will be achieved using a combination of trainer presentations, trainer-led plenary discussions, and case studies.

Digital Learning Catalog

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Signal Management in Pharmacovigilance