Overview

Module 4: Signal Management covers GVP Modules IX and X. New safety signals may emerge at any time following product launch and must be evaluated for relative risk, medical importance, and likelihood of occurrence. Signal Management is, therefore, one of the crucial “routine” Pharmacovigilance activities. Approaches to Signal Management using qualitative and quantitative methods will be illustrated in a workshop with examples as well as general considerations on signal management in the EEA.

Featured topics

Signal Detection in the EU
Signal Management in the EU

Who should attend?

Professionals with experience in safety related activities of the drug development process and/or those with a need of a holistic overview about all PV related regulatory requirements will benefit most, such as:

Pharmacovigilance Officers, Managers, Specialists, Experts, or Coordinators
Regulatory Compliance, Quality or Safety departments Heads, Directors or Managers

Level: /Intermediate

TECHNICAL REQUIREMENTS

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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

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