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Real-Time
Adverse Event Analysis Using IVR
Hal
Ward
Executive Director
Global Head of Drug Safety
Covance
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recording US$199
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Purchase
recording of this audio conference
This audio
conference will provide 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
will suggest 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 will enable you to immediately improve your understanding
of AEs without any additional capital expenditure.
This audio
conference will:
- 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.
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