This virtual live training course Module 1 includes a concise overview of the objectives and the scope of Pharmacovigilance. Key definitions based on Community legislation and consensus, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and the CIOMS Working Groups will be explained. Practical examples and exercises will be used to illustrate the basic definitions in Pharmacovigilance and the methods used in Pharmacovigilance.

Level: Beginner

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 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)