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Virtual

Nov 16, 2022 9:00 AM - Nov 16, 2022 5:00 PM

(Central Europe Standard Time)

DIA/MEB Excellence in Pharmacovigilance. Module 3: Risk Management

GVP Modules V, VIII, XV and XVI

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

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 Assessor
    MEB, Netherlands

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