Open Webinar Will Address Practical Aspects of Drug Safety Perspective of REMS Development
13 Juli 2010 - 5:04PM
Business Wire
The practical aspects of utilizing a drug safety perspective in
the development and implementation of Risk Evaluation and
Mitigation Strategies (REMS) will be examined in a complimentary
webinar for all interested parties this Wednesday, July 14, at 12
noon Eastern Time.
Entitled “Considering a Drug Safety Perspective of REMS,”
the program will also celebrate the second-half of the year-long,
monthly webinar series “Wednesday FoREMS” sponsored by ParagonRx,
an inVentiv Health, Inc. company (NASDAQ:VTIV), and a leading
consulting company specializing in pharmaceutical risk management
and optimizing medication.
“Inherently, REMS is a cross-disciplinary activity, requiring
the participation and insights of many functional groups to be
successful,” says Jeffrey Fetterman, President of ParagonRx. “Each
function has a unique perspective that is essential to designing
and implementing an effective risk mitigation plan. This month we
will delve into the Drug Safety perspective.”
Billy Holden, Chief Safety Officer of ParagonRx, will present a
practical framework for quantitatively characterizing the
benefit-risk profile of pharmaceutical products. Although all risk
management is grounded in data arising from clinical trials and
post marketing experience, too often the benefit-risk
characterization and REMS design is qualitative in nature because
risk and benefits are measured in different units, making a
quantitative synthesis rather challenging.
Also presenting will be Rekha Garg, Executive Director of Risk
Intervention Strategy and Communication at Amgen, who will discuss
her company’s experiences leading the implementation of multiple
REMS. She will share a model showing how a strongly centralized
organization can functionally align with global safety, leading to
a cross-functional implementation plan that requires the
cooperation and commitment of many individuals across the
company.
More information about registering for the “Wednesday FoREMS”
webinar series can be found at www.paragonrx.com/rems-hub/forems/.
Webinars will be held the second Wednesday of each month at 12 noon
EDT.
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