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Sentrx Announces Reseller Agreement with Zenosis Limited
Coincides with the Release of Zenosis Pharmacovigilance Modules
Little
Falls, NJ – October 29, 2004 – Sentrx, the leading provider of
technology-enabled solutions for global drug safety, announced today that it has
signed an agreement with Zenosis, the leading provider of always up-to-date
online regulatory training and support materials for the life science industry.
Sentrx will be a reseller of Zenosis modules in the United States.
The announcement
coincides with the release of two Pharmacovigilance modules from Zenosis, both
authored by Stanley B. Garbus, MD, MPH, co-founder and Chief Medical Officer of
Sentrx. In the Overview of
Pharmacovigilance module, the student will be introduced to the basics of
drug safety, pre-marketing and post-marketing requirements, signal generation
and analysis. In addition, the student will receive practical pointers on good
clinical practice, risk management and crisis planning.
The
companion Pharmacovigilance Systems in the
EU and USA module covers systems of monitoring and reporting
pharmacovigilance, approval procedures, prescription-to-OTC switch procedures,
the EU Clinical Trials Directive, and inspections in both the EU and USA.
“We are very
excited about the release of the Pharmacovigilance Module,” said Simon
Burgess, Chief Executive Officer of Zenosis.
Dr. Garbus has been able to capture his decades of experience and deliver
it through the Zenosis learning and reference environment.
He has done a fantastic job of teaching the critical components of drug
safety.”
Pharmacovigilance
is growing in importance and complexity around the world.
In the US, it has become an important component of broader pharmaceutical
risk management objectives. Three
new draft guidance documents on risk management, when finalized and published,
will represent the U.S. Food and Drug Administration’s (FDA's) policy on
pre-marketing risk assessment, good pharmacovigilance practices, and the
development and use of risk minimization action plans (RiskMAPs).
Also in draft form from FDA is the Proposed Rule on Safety Reporting
Requirements for Human Drug & Biological Products, commonly referred to
as “The TOME,” which if adopted will increase the quantity and quality of
safety information reported.
As
with all Zenosis training courses, the Pharmacovigilance Modules will be updated
regularly, and Zenosis customers will have access to the most current versions
at all times. This feature protects
a company’s investment in training and is particularly important in a changing
regulatory environment.
With
the release of the Pharmacovigilance modules, Sentrx will become a reseller of
all Zenosis training courses. Joseph
Albano, Chief Executive Officer of Sentrx, commented, “Biopharmaceutical
companies often look to Sentrx for training because of our extensive experience
in drug safety. Now that Zenosis
has packaged our expertise into a proven delivery method, Sentrx is pleased to
broaden our solutions and at the same time contribute to the expansion of
Zenosis in the US.”
About
Zenosis
Zenosis is a
Regulatory Affairs, e-Learning, Application Service Provider (ASP). ASPs provide
services that are accessible over the Internet, based upon a subscription model.
Zenosis is the first online educator to provide a structured, logical and
comprehensive approach to training in regulatory and compliance topics.
Zenosis
provides a unique, economical e-learning solution that is constantly updated to
reflect changes in the regulatory environment. Its ever-expanding portfolio of
modules provides managers and professionals with fingertip access to accurate
and comprehensive subject knowledge 24/7. For
more information on Zenosis and a complete list of modules available, please
visit www.zenosis.com. For subscription information in the US, please call Sentrx at
1-888-399-8032. For subscription
information in Europe, please call Zenosis at +44(0)8700 46 45 54.
About Sentrx
Sentrx is a
leading provider of technology-enabled solutions and services for global drug
safety. Its mission is to manage
the safety risks associated with developing and marketing pharmaceuticals.
Through its multilingual Safety Response Center, Sentrx delivers a unique
combination of highly skilled people, exclusive technology, and best practices
in drug safety monitoring. To learn
more about Sentrx, please visit their website at www.sentrx.com;
send an e-mail to info@sentrx.com; or call
1-888-399-8032, extension 261.
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