Overview

Module 3: Risk Management corresponds to GVP Modules V, VIII, XV and XVI. In accordance with the GVP Module V on Risk Management System, Risk Management Plans (RMPs) should be submitted by companies to propose activities aiming to identify, characterise or minimise risks associated with medicinal products. Given the potential public health implications and costs of such interventions, RMPs should be based on robust data. Specific examples of data collection and analysis will be presented in this session. Besides, pharmaco-epidemiological studies, which are the fundamentals of “additional” Pharmacovigilance activities, are discussed. This session also presents recent developments regarding risk communication.

Featured topics

Risk Management Plans
Harmonisation of RMP (HaRP) in Europe
Epidemiological Methods and Pharmacovigilance
Effectiveness of Risk Minimisation Measures
Risk Communication in EU

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

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