| Wondering
How the New Data Standards Will
Affect Your Organization?
Here's an event you won't want
to miss. It's a revealing two-day
workshop where the FDA and major
pharma companies will give you
what you'll need to know about
integrating CDISC and HL7 into
your company, into your operations,
into your clinical activities.This
unique program is sponsored by
CDISC itself, the non-profit organization
responsible for developing the
industry standards for exchanging,
submitting, and archiving clinical
trial data.
The workshops are also adjunct
to CDISC's Education Courses. Register
now to reserve one or more seats
for your organization. To maintain
a manageable learning environment,
enrollment must be limited. So
if you have any need to learn about
CDISC and HL7 implementation, we
suggest you enroll now. To register
email Shirley Williams at swilliams@cdisc.org.
Call 512-341-9885 for more information.
Sorry, we must restrict registration
to regulatory, IT and clinical
data professionals, as well as
pharma and biotech clinical researchers.
Learn How to Profit >From These
Standards in Your Organization
In just two days of intensive
training, you will know more about
CDISC, HL7, XML -- and what the
FDA is saying about them, than
most pharmaceutical professionals
-- and know precisely how to make
them work together for your organization's
operations. This world-class team
will guide you through the intricacies
of standards integration -- no
matter what data protocols or software
you're using now. Instead of poring
over detailed standards documentation
yourself, you will get the streamlined,
simplified story straight from
professionals who actually use
and understand CDISC, HL7 and XML
in the real world, in actual applications.
It's faster, and more efficient.
Hundreds of satisfied participants
in this seminar series since it
was first offered in July 2003.
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Taught
by the industry's leading standards
experts. Your instructors are:
*your
Program Chair, Michael Palmer,
President, Zurich Biostatistics
Inc.
and,
In California:
* Rebecca Kush, PhD, President, CDISC
* Steven Gitterman, MD, PhD, Deputy
Director, Special Pathogen and Immunologic
Drug Products, CDER, FDA
* Wes Rishel, Immediate Past Chair,
HL7, Vice President, Research Area
Director, Gartner Research, Healthcare
and,
* Seema Handu, PhD, President & CEO,
PharmQuest Corporation
In New Hope, Pennsylvania:
* Norman Stockbridge, MD, PhD, Deputy
Director, Division of Cardio-Renal
Drug Products, CDER, FDA
* Frank Newby, Vice President, Education/Member
Relations, CDISC
* Liora Alschuler, HL7 committee
Chair and Consultant, alschuler.spinosa,
East Thetford, Vermont From industry:
In California:
* Patricia Gerend, Senior Manager,
Statistical Programming, Genentech
Inc.
* Adrian Hsing, Director, Clinical
Data Management, Gilead Sciences
* Phillip Liu, Senior Manager,
Clinical Applications Programming,
Theravance
In New Hope, Pennsylvania:
* Anthony Tenaglia, IS Manager,
USHH Clinical Development, Merck & Co.,
Inc.
* Raymond C. Heimbuch, Senior Principal
Programmer, Novartis Pharmaceutical
Over two full days, covering topics
such as:
* What CDISC and HL7 really entail
-- and what they don't.
* How to determine exactly what
applies to you, and what doesn't.
* How it affects your existing
data resources. What do you need
to update? What can remain as is?
* Should you be changing your protocols
or data collection? Or simply how
you record it all? (The wrong answer
can mean months of delay.)
* What's the fastest way to modify
your existing software systems?
* Where and when should you be
using XML?
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