Overview

The course will teach basic concepts of signal detection and signal management and how to apply them within the participants' functions, including the data mining techniques for large volume ADR data analysis, relevant EMA guidelines as well as a future outlook.
The entire course is updated in line with the latest guidelines on EU Good Pharmacovigilance Practices (GVP): Module IX – Signal management, Commission Implementing Regulation (EU) No. 520/2012, and CIOMS VIII. Time has been set aside for exercises, questions and discussions.

Participants will be provided with preparatory material in order to better participate at the group exercises onsite.

Participants are kindly requested to read the GVP Module IX before the course.

“DIA events provide the ideal platform to exchange experience with colleagues across the industry and the trainings are really of a very high utility.”
Munish Kumar Kaushik, Associate Director, Jubilant Generics Ltd.

What you will learn

Signal detection – Theory, methods, data mining
Signal management – Detection, triage, evaluation, further action
Signal management – Regulatory expectations
Signal management process: Strategy for implementation

Who should attend?

This course will benefit professionals working in:

Pharmacovigilance (including QPPVs)
Drug safety and patient safety risk management
Pharmacoepidemiology
Information Technology
Regulatory Affairs
Pharmacovigilance consultancies
Quality and Compliance
Legal

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

Learning objectives

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

Apply the basic concepts and principles of signal detection in pharmacovigilance, from simple visualisation and tabulation methods to sophisticated data mining techniques
Design the signal management process for institutions and companies of various sizes, portfolios and geographical presence, based on the possibilities and limitations of their data and resources
Understand key messages from the current European and US regulations on signal management, to best manage implications of signals for the future of pharmaceutical companies and products

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

Why not take advantage and train your whole department (or even across different departments!) and benefit from increased:

Focus
Flexibility
Convenience
Cost Effectiveness

For more information please contact Basel@DIAglobal.org

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Signal Management in Pharmacovigilance