Overview

Your Instructor: Jan Petracek
Director, Institute of Pharmacovigilance
“Modern design of pharmacovigilance system including digital transformation represent daily challenge for PV decision makers. Overwhelming amount of data waiting for interpretation is one of the biggest challenges. But how to get good information from data collected with various motivations, under different regulations, standards, protocols, jurisdictions? We have designed a new course to look at the heart of this challenge and help those in charge to set a system that uses the best practices in PV available today to battle grey zones and to get the most from your data.”

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)

Digital Learning Catalog

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Best Practices for Data Supervisors in Pharmacovigilance