Identifying Safety Signals by Data Mining the FDA Adverse Event Reporting System with Oracle Empirica Signal

by Eugene Sefanov

Ever since the European Union (EU) introduced new legislation that requires life sciences companies to proactively detect, prioritize, and evaluate safety signals, there has been an increased interest, not only from sponsors in the EU, but globally, in pharmacovigilance systems that can assist with the signal management process.

Please join BioPharm’s Christina Wocosky, an expert in signal detection and management, for a free one-hour webinar in which she will discuss how your organization can use Empirica Signal, Oracle’s state-of-the-art signal detection system to data-mine the existing FDA Adverse Event Reporting System (FAERS) to determine safety signals. After attending this presentation and demonstration, registrants will better understand how this solution can be used in daily pharmacovigilance activities.

Register to view the webinar at https://cc.readytalk.com/r/7ekwxbm7q33t&eom

For more information about BioPharm Systems, please visit www.biopharm.com.

INTEGRATING ORACLE ARGUS SAFETY WITH OTHER CLINICAL SYSTEMS USING ARGUS INTERCHANGE’S E2B FUNCTIONALITY

by Eugene Sefanov

Over the past few years, companies conducting clinical trials have increasingly been interested in integrating their pharmacovigilance systems with other clinical and safety solutions to streamline their processes.

Please join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for a one-hour webinar in which he will discuss the ability to integrate Oracle’s Argus Safety with other applications using the safety system’s inherent extended E2B functionality.

This presentation will cover two Argus Safety integration projects – one that has been completed and one that is ongoing. The discussion will include the conceptual framework for these integration bridges and will identify issues, concerns, and their respective mitigation strategies.

After attending this tutorial, you will have an increased understanding of Argus’ extended E2B capabilities and the typical points of discussion for similar projects.

Register to view the webinar: https://cc.readytalk.com/r/x4mjn5dm2r06&eom

To learn more about BioPharm, please visit www.biopharm.com.

EVALUATING AND INVESTIGATING DRUG SAFETY SIGNALS WITH PUBLIC DATABASES

by Eugene Sefanov

In this one-hour webinar, BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, will review a number of public databases available to use during the evaluation and investigation of identified safety signals. The discussion will focus on the use of free and paid longitudinal healthcare databases available online. After attending this presentation, you will better understand how these data sources can be used in your daily PV work.

Agenda Highlights:

• Overview of Signal Management
• Overview of Epidemiology
• Review of free and paid databases

Register to view the webinar: https://cc.readytalk.com/r/eagsm4a1unid&eom

To learn more about BioPharm, please visit www.biopharm.com.