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Joint DIA/MEB “Excellence in Pharmacovigilance” Module 2: Safety Aspects in Clinical Trials

Module 2 will provide the safety reporting requirements, the roles, and responsibilities of all stakeholders in clinical trials.


Overview

Module 2 of the Joint DIA/MEB "Excellence in Pharmacovigilance" virtual live training course will provide the safety reporting requirements with case studies, the roles, and responsibilities of all stakeholders in clinical trials in line with the implementing texts published in relation to Directive 2001/20/EC and the new Regulation (EU) 536/2014.

This module will also provide an understanding of safety data classification, using MedDRA terminology and safety data retrieval using Standardised MedDRA Queries (SMQs).



 

Featured topics

  • SUSAR Reporting in Clinical Trials
  • Preparation of Development Safety Update Reports (DSURs)
  • MedDRA and Standardised MedDRA Queries (SMQs)
  • Clinical Trials Regulation (EU) NO 536/2014 – Safety Reporting and Monitoring. What will change?

 

Who should attend?

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)

 

Program Committee

  • Wendy  Huisman, PharmD
    Wendy Huisman, PharmD Director
    Vigifit, Netherlands
  • Fakhredin Sayed Tabatabaei, MD, PhD
    Fakhredin Sayed Tabatabaei, MD, PhD Senior Pharmacovigilance Assessor
    Medicines Evaluation Board, Netherlands
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