Publications

Balancing Act Between AERS Security and Inactivity

This poster presents a real-life example of how companies configure the Oracle AERS inactivity timer and assess cost/benefit. A review of AERS and web settings is presented to give the audience a thorough understanding of proper configuration. Presented at the 2010 Oracle Health Sciences User Group by Jefferson Yosuico, Senior Consultant.

Effective Safety Process Metrics

There are a number of interesting and effective metrics for managing the process of collecting and reporting drug safety cases. This presentation will discuss some of these metrics, as well as how best to generate the data and present it to different resources in your organization. Presented at the 2010 Oracle Health Sciences User Group by Raul Inchausti, Vice President.

Going Paperless Globally

Global pharmacovigilance processes tend to be extremely paper-intensive. This dependency on paper stems from the lack of adequate support for the initial intake, follow-up, and triaging steps as well as a reliance on traditional business processes for the management of source documentation. With each local office and data stream left to solve the intake process, the global pharmacovigilance offices are inundated with a diverse set of inbound data formats and content, leading to redundancy and process inefficiencies. This paper discusses the use of a streamlined data capture system such as PRIMO to implement a standard, global report intake and triage process. Presented at the 2010 Oracle Health Sciences User Group by Brad Gallien, Vice President.

Browse Portal Objects or Files UsingWindows Explorer

This presentation details how to deploy the Oracle Portal WEBDAV plug-in to allow navigation Portal files and folders using Windows Explorer. Presented at the 2010 Oracle Health Sciences User Group by Andy Sutan, Principal Consultant.

Oracle AERS and Argus Insight and Perceptive

This paper presents one way to generate continued value from your AERS implementation by integrating the Oracle Argus Insight and Perceptive tools with Oracle AERS to add flexible reporting and signal management capability. Presented at the 2010 Oracle Health Sciences User Group by Pat Bagely, Vice President.

Quantifying the Financial Impact of Drug Safety

The talk focuses on how to quantify the costs and the value associated with managing, reporting and understanding drug safety cases in order to optimize your return on investment. Presented at the 2010 Oracle Health Sciences User Group by François Audibert, Senior Director.

EU Reportability Issues

This presentation discusses the complex issues around the determination of reportability for EU countries. In addition, it will touch on issues of electronic reporting for centrally approved and locally approved products. Presented at the 2010 Oracle Health Sciences User Group by Amy Bosch, Senior Consultant.

REMS: Opportunities for Improvement and Redesign

This presentation discusses the best practices in designing, leading and implementing REMS Programs to achieve REMS effectiveness. Presented at the 2010 Oracle Health Sciences User Group by Manisha Dikshit, Senior Consultant.

Aspects of Upgrading Argus Safety

This paper provides an overview of the many aspects involved for an Argus Safety upgrade. The advantages and challenges from technical and functional perspectives. Presented at the 2010 Oracle Health Sciences User Group by Mike Gallegos, Senior Consultant.