Overview

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This virtual live training 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.

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 virtual live training 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 virtual live training 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

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

TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

Operating Systems

Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
Mac OS X: 10.5, 10.6, 10.7
Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirement

Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access

Browsers

Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
Mac OS X: Intel processor, At least 512 MB RAM
Linux: At least 512 MB RAM

Display

800x600 pixel resolution or greater (1024x768 pixels recommended)

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Signal Management in Pharmacovigilance Virtual Live Training Course