The roles and responsibilities of marketing authorisation holders and national Competent Authorities in the conduct of Pharmacovigilance are defined in EU legislation and further detailed in the Good Pharmacovigilance Practices (GVP). Module 2 virtual live training will provide the safety reporting requirements with case studies, the roles and responsibilities of all stakeholders in clinical trials in line with the implementing texts published in relation to Directive 2001/20/EC and the new Regulation (EU) 536/2014. It will also cover individual and periodic adverse reaction reporting requirements of marketing authorisation holders in the post-authorisation phase with illustrations based on case studies.
This module will also provide an understanding of safety data classification, using MedDRA terminology and safety data retrieval using Standardised MedDRA Queries (SMQs).
Key elements will be provided for the establishment of a quality system in Pharmacovigilance including aspects of the applicable GVP modules, the elaboration of Standard Operating Procedures (SOPs) and the preparation for audits and inspections.

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 Requirements

• 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)