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

Module 4 focus on risk minimisation measures from both regulatory and industry perspectives. It also covers epidemiological methods used in Pharmacovigilance, as well as risk management plans.


Overview

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.



 

Featured topics

  • 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

 

Who should attend?

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)

 

Program Committee

  • Wendy  Huisman, PharmD
    Wendy Huisman, PharmD Director
    Vigifit, Netherlands
  • Fakhredin Sayed Tabatabaei, MD, PhD
    Fakhredin Sayed Tabatabaei, MD, PhD Senior Pharmacovigilance Assessor
    Medicines Evaluation Board, Netherlands
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