December 13, 2012
UMDNJ-SHRP Launches
State's Only Drug Safety & Pharmacovigilance Masters and
Certificate Program
The University of
Medicine and Dentistry of New
Jersey–School of Health Related
Professions (UMDNJ-SHRP) launches a
new online Masters degree program in
Clinical Trial Sciences—Drug Safety
& Pharmacovigilance, the only such
degree offered in New Jersey and one
of just a few across the nation
training professionals in this
growing health field. It is also
offering a Drug Safety &
Pharmacovigilance certificate
program. Both will be offered in
collaboration with the University of
Montreal.
Due to recent
government initiatives, training in
pharmacovigilance and reporting of
adverse reactions to drugs is a
rapidly growing need, which promises
employment opportunities.
“Consider the drug
recalls you hear about,” says
Barbara Gladson, PhD, who is
director of the MS in Clinical Trial
Sciences. “There is a new regulatory
environment related to reporting
adverse events as well as new
quantitative methods for signal
detection both during the clinical
phase of drug development and also
during the post-marketing period.”
Gladson notes that
both the U.S. Food and Drug
Administration (FDA) and the
European Medicines Agency (EMA) have
developed offices of drug safety and
surveillance. The FDA has promoted
these activities under a new
discipline entitled “Regulatory
Science Initiative” and defined as
the “science of developing new
tools, standards and approaches to
assess the safety, efficacy,
quality, and performance of all
FDA-regulated products.”
There are numerous
other related initiatives that are
either current or in developmental
stages, she adds.
“This area of
science is important because we
currently do not have a good way to
detect adverse drug reactions [ADRs]
once a product is released on the
market,” says Gladson. “And during
the drug development stages, most of
the protocols are written to look at
efficacy and not harm. These
protocols would be structured
differently if they could detect the
ADR early on in the process.”
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