• GVP IX
• Addendum I to GVP IX and Screening for adverse reactions in EudraVigilance
• Principles of access in EudraVigilance
• EVDAS pilot
• EVDAS
• Practical exercise including
• eRMR analysis and documentation
• Line listing analysis
• Communication of potential duplicates to the EMA
• Other sources of information
• CMDh list of safety concerns
• Referrals page on the EMA website
• List of signals discussed by the PRAC since 2012
• Literature search including non-clinical safety findings
• How to escalate signals, e.g. stand-alone notification, ESI

This virtual live training course is aimed at professionals who work in:

• Pharmacovigilance (including QPPVs)
• Drug Safety and Patient Safety Risk Management
• Information Technology
• Pharmacovigilance Data Management
• Pharmacovigilance Consultancies
• Quality and Compliance

Course level: Intermediate, for professionals with 2-3 years of experience in Pharmacovigilance who work in the area of signal management, but have no or limited experience on how to use EVDAS for signal detection.

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

• Understand regulatory requirements for Signal Management in Europe (GVP IX and Addendum I)
• Describe principles of screening EudraVigilance for adverse reactions and the EudraVigilance data access policy
• Identify levels and methods of access to Individual Case Safety Reports (ICSRs) data and understand the terminology of EVDAS
• Learn to use active substance grouping reports, electronic reaction monitoring reports (eRMRs)
• Analyse eRMRs with various reference periods and line listings and document your assessments
• Identify potential signals and know how to escalate them to the National Competent Authorities (NCAs) and the European Medicines Agency (EMA)

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)