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Virtual

Sep 28, 2021 1:00 PM - Sep 30, 2021 7:00 PM

(Central Europe Standard Time)

Best Practices for Data Supervisors in Pharmacovigilance Virtual Live Training Course

NEW OFFERING for Supervisors of Data Entry Managers and Data Quality Assurance Managers!

Overview

Advances and developments in data use in pharmacovigilance are driving new training needs and demands. The sheer volume of data, along with the enforcement of new ISO standards for Individual Case Safety Reports, have created a pressing need for industry best practices to cover numerous aspects of working the data. These include data entry conventions, management data, quality assurance and preparing to work with AI tools, all within the limitations imposed by the EU GDPR.

 

Featured topics

  • Data Flow in the Pharmacovigilance System – Best Designs
  • Data Recording Conventions Examples
  • Eudravigilance
  • Conflict Resolution
  • Data Quality Check of ICSRs entered in ISO ICSR Standard
  • Training of an AI Machine
  • Data Management Defense Practice in Front of an Inspector/Auditor

 

Who should attend?

This course is intended for the professionals working within the pharmaceutical industry, academia, governmental institutions as well as IT solution providers in pharmacovigilance, drug safety, quality assurance/quality control, and IT and validation positions.
Level: Intermediate

 

Learning objectives

At the conclusion of this course, participants will be able to:

  • Apply knowledge of the industry best practices at your supervisory/managerial job
  • Understand most important impacts of the new regulatory requirements stemming from ISO/HL7 27953-2, ICH E2B(R3), and their implementation guides in the EU and US, 
  • Orient yourself in the context of near future upcoming revisions of ICH E2D, and impact of US Sentinel and EU Darwin projects
  • Acquire conflict resolution skills related to contradictory guidelines and legislation, data exchange partner practices, and legacy practices
  • Improve your defensive skills for your data management practices in front of inspectors and auditors
  • Get ready for upcoming AI tools in pharmacovigilance

  

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

  • Jan Petracek, MD, MSc
    Jan Petracek, MD, MSc CEO
    Ivigee, Czech Republic

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