概览

Module 4 of the Joint DIA/MEB "Excellence in Pharmacovigilance" virtual live training course is dedicated to Risk Management.

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. Examples will be discussed in this module.

Nonetheless, specific data collection and analysis are desirable for some safety issues, and pharmaco-epidemiological studies are the most performed tools of those “additional” Pharmacovigilance activities. This module also presents recent developments regarding risk communication.

精选主题

Risk Management Plans – Regulatory Perspective: GVP Module V Revision 2
Risk Management Plans – Industry Perspective
Epidemiological Methods and Pharmacovigilance
Effectiveness of Risk Minimisation Measures – Regulatory Perspective
Effectiveness of Risk Minimisation Measures – Industry Perspective
Harmonisation of RMP (HaRP) in Europe
Risk Communication in EU – Challenges and Possibilities

谁应该参加？

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

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

Download

Joint DIA/MEB “Excellence in Pharmacovigilance” Module 4: Risk Management