概览

Module 5 of the Joint DIA/MEB "Excellence in Pharmacoviglance" virtual live training course covers Signal Management and Detection in the EU.

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.

精选主题

Introduction to Signal Detection in the European Union – Regulatory Perspective
Signal Management in the EU – Industry Perspective

谁应该参加？

This module is aimed at individuals from the pharmaceutical industry, academia, and regulatory authorities with experience in the clinical safety/pharmacovigilance area.

Level: Intermediate.

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)

项目委员会

Wendy Huisman, PharmD VP Quality and Patient Safety
Avanzanite Bioscience, Netherlands
Fakhredin Sayed Tabatabaei, MD, PhD Senior Assessor
MEB, Netherlands

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Joint DIA/MEB “Excellence in Pharmacovigilance” Module 5: Signal Management