概览

In this Introduction to the Joint DIA/MEB Excellence in Pharmacovigilance virtual live course, 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.

The Joint DIA/MEB Excellence in Pharmacovigilance virtual live course, split into 5 individual modules can be booked separately:

精选主题

History and Legal Basis for Safety Reporting and Basic Principles, Definitions, and Tools
Introduction to Risk Communication

谁应该参加？

This module is aimed at individuals from the pharmaceutical industry, academia, and regulatory authorities with limited experience in the clinical safety/pharmacovigilance area.

Level: Beginner.

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

800x600 pixel resolution or greater (1024x768 pixels recommended)

项目委员会

Wendy Huisman, PharmD VP Quality and Patient Safety
Avanzanite Bioscience, Netherlands
Fakhredin Sayed Tabatabaei, MD, PhD Senior Assessor
MEB, Netherlands

Digital Learning Catalog

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Introduction to Joint DIA/MEB "Excellence in Pharmacovigilance"