Optimizing Adverse Event Case Processing Workflow
Followed by
Signal Tracking – Prioritizing, Tracking and Managing Signals

Wednesday, 21 April 2010, 13:30 – 16:30

Workshop Outline:
Streamlining the processing of adverse event reports is a challenge for all drug, medical device and vaccine manufacturers. There is a need for greater efficiency while maintaining strict compliance with time lines and an improvement in the quality of information to support signal detection and analysis. This workshop will explore the features of the Empirica™ Trace product relevant to optimizing case processing workflow from initial data quality through to metrics reporting and automated report delivery.

Workshop Leader:
Eric Draelants, Senior Consultant

Signals of potential risks with medical products can be generated from a variety of sources including spontaneous adverse event reports, clinical studies and observational studies. The signals can be raised internally by a Drug Safety Department or externally by regulators and others. This workshop will describe processes and tools for prioritizing, tracking and managing signals from any source. Lessons will be drawn from a series of recent and ongoing projects.

Workshop Leader:
Robert Weber, Principal Consultant

To register for the conference
To view our preliminary agenda