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Virtual Event

2021 年 11 月 17 日 8:30 上午 - 2021 年 11 月 18 日 12:30 下午

(Central Europe Standard Time)

4051 Basel, Switzerland

Joint DIA/MEB “Excellence in Pharmacovigilance” Module 3: Quality Management System

In Module 3, key elements will be provided for the establishment of a quality system in Pharmacovigilance including aspects of the applicable GVP modules the preparation for and the conduct of audits and inspections.

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概览

Module 3 of the Joint DIA/MEB “Excellence in Pharmacovigilance” covers establishment of a Quality Management System in Pharmacovigilance. It includes aspects of the applicable GVP modules, as well as preparation and conduct of audits and inspections. This module also addresses risk-based assessments, document management and PV agreements.

 

精选主题

  • Pharmacovigilance System Master File (PSMF)
  • Audits and Inspections in Pharmacovigilance – Regulatory Perspective
  • Audits and Inspections in Pharmacovigilance – Industry Perspective
  • ”Risk based” Activities, Documentation and Pharmacovigilance Agreements
  • Role of the Qualified Person Responsible for PV (QPPV)

 

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

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