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.

A Brief Guide to the FDA Drug Approval Process

by Eugene Sefanov

This infographic describes the FDA drug approval process.

FREE WEBINAR: STREAMLINING A GLOBAL LIFE SCIENCES COMPANY’S PHARMACOVIGILANCE OPERATIONS

by Eugene Sefanov

As the focus on international product safety regulations increases, life sciences organizations must globalize and enhance their safety and pharmacovigilance operations in order to successfully navigate through the challenges they are presented with.

Join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar that will discuss a major pharmaceutical company’s pharmacovigilance globalization initiative that helped standardize and streamline its operations.

Several topics that will be discussed include:

• SOP Integration
• Standardization of Local Practices
• Departmental Coordination
• Varying Reporting Requirements

Register to view the webinar at https://cc.readytalk.com/r/14um1yqp5jps.

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

Free Webinar: Merging Multiple Drug Safety and Pharmacovigilance Databases into One Global Oracle Argus Safety System

by Eugene Sefanov

Many sponsors and CROs rely on an IT infrastructure that includes multiple disconnected safety and pharmacovigilance systems that vary by region and vendor. Although merging these systems into a single global solution may seem daunting and provide you with many technical challenges, it could be a crucial goal on the horizon for your organization.

Please join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar in which he will review a recent project for a top pharmaceutical company that entailed the merging of multiple drug safety systems into one global Argus Safety pharmacovigilance system.

Specific topics that will be examined include:

• Adverse Event Case Migration
• Merging and Configuring
• Data Cleansing and Consistency
• Configuring Reporting Rules

Register to view the webinar at https://cc.readytalk.com/r/nu2vem0xprkr.

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

FREE WEBINAR: USING ORACLE’S EMPIRICA TOPICS TO DOCUMENT YOUR SIGNAL MANAGEMENT PROCESS

by Eugene Sefanov

Signal management, the detection, prioritization, and evaluation of signals, is a crucial activity that life sciences organizations should continuously perform in an effort to ensure their products are not related to excessive risks in relationship to the products’ benefits. With the emergence of comprehensive and user-friendly signal management solutions, the management of signals has become easier and more effective.

Oracle’s Empirica Topics is a powerful tool that helps companies track information and activities that are related to potential safety and pharmacovigilance signals. For example, after the creation of a signal topic, it can be delegated to members of a safety team for documenting the prioritization and evaluation of the signal. This transparent and collaborative process can protect your organization in an audit and ensure you have a well-established methodology for signal management.

Join BioPharm Systems’ Dr. Rodney Lemery, vice president of safety and pharmacovigilance, for this free one-hour webinar that will explore why and how Empirica Topics can be:

• Implemented and configured using BioPharm’s unique methodology
• Utilized to strengthen your pharmacovigilance systems and processes, by employing techniques promoted by the Council for International Organizations of Medical Sciences (CIOMS) Working Group VIII

Register to view the webinar at https://cc.readytalk.com/r/wjvsun6v20rp.

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