Overview

Module 1 of the Joint DIA/MEB "Excellence in Pharmacovigilance" virtual live training course will cover individual and periodic adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase with illustrations based on case studies as practical examples.

Featured topics

Keynote by PRAC: Present and Future of Pharmacovigilance
Expedited Reporting Requirements in the Post-Authorisation Phase
Reporting Requirements in Special Situations in the Post-Authorisation Phase
Clinical Evaluation of Adverse Drug Reactions
Preparation of Periodic Safety Update Reports (PSURs)

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

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

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