Overview

Module 3 of the Joint DIA/MEB “Excellence in Pharmacovigilance” covers establishment of a Quality Management System in Pharmacovigilance. It includes aspects of the applicable GVP modules, as well as preparation and conduct of audits and inspections. This module also addresses risk-based assessments, document management and PV agreements.

Featured topics

Pharmacovigilance System Master File (PSMF)
Audits and Inspections in Pharmacovigilance – Regulatory Perspective
Audits and Inspections in Pharmacovigilance – Industry Perspective
”Risk based” Activities, Documentation and Pharmacovigilance Agreements
Role of the Qualified Person Responsible for PV (QPPV)

Who should attend?

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

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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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