This audio conference provides an overview of practical considerations regarding the challenges of obtaining adverse event (AE) data, particularly in real-time. A fundamental challenge in the adverse event reporting arena is a lack of, or incorrect, information on patient exposure data and AE incident reporting.

This presentation suggests a strategy for utilizing your IVRS data stream to enhance understanding of patient exposure and enable real-time, proactive decision-making on the progress of the clinical trial. Data already captured in your IVR can provide significant insight into clinical trial performance and improve your understanding of adverse events in your trial. The strategy presented in this audio conference enables you to immediately improve your understanding of AEs without any additional capital expenditure.

This audio conference covers:

• Analyze current obstacles to obtaining real-time AE data
• Discuss AE challenges in obtaining exposure rates and population data
• Review clinical data captured in an IVR system
• Recommend how to use existing IVR data to improve incident reporting
• Identify ways to gain access to population exposure characteristics (i.e. disease stratification, geographic exposure, among others)
• Discuss accuracy of IVR data compared to other data sources

About the speaker:

Hal Ward, R.Ph., Pharm.D. is the Executive Director and Global Head of Drug Safety at Covance Late Stage Development Services Clinical Division. As Executive Director, Hal has overall responsibility for the Drug Safety organization at Covance, including accurate and timely regulatory reporting, implementation of quality assurance and quality improvement plans, implementation of training and SOP programs, measurement of productivity and workload efficiency, and client satisfaction.

Prior to joining Covance in 2006, Hal led the Global Medical Affairs Compliance Training team at Wyeth. He also led the Drug Safety Training team at Wyeth's Global Safety Surveillance and Epidemiology division. Prior to that, he led the Gastrointestinal team at Astra Merck's Product Safety and Epidemiology division.

Hal earned his B.A. in Biology from the University of Pennsylvania in 1983, the B.S. in Pharmacy from the Philadelphia College of Pharmacy in 1988 (magna cum laude) , and the Doctor of Pharmacy degree from the Philadelphia College of Pharmacy in 2000 (magna cum laude). He is a registered pharmacist in the state of Pennsylvania, and a Test Writer for the National Association of Boards of Pharmacy License Examination (NAPLEX) since 1988. He has published several abstracts and articles related to the pharmaceutical industry.

Who should attend?

• Middle & Senior Management - R&D
• Operations
• Program Management
• Data Managers
• IVR Project Managers
• Outsourcing Managers
• Risk Mitigation

This audio conference is classified as General Interest.