Overview

Module 2: Quality Management System covers GVP Modules I to IV and will provide the safety reporting requirements with case studies, as well as safety data classification, using MedDRA terminology and safety data retrieval using Standardised MedDRA Queries (SMQs). It covers establishment of a Quality Management System in Pharmacovigilance and includes aspects of the applicable GVP modules, as well as preparation and conduct of audits and inspections.

Featured topics

SUSAR Reporting in Clinical Trials
MedDRA and Standardised MedDRA Queries
Pharmacovigilance System Master File
The Role of the QPPV
Audits and Inspections in Pharmacovigilance
Quality Management System

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

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