ThinSpring™ President
Ron Celeste Will Present “Electronic Submission
of Regulatory Information: Creating an Electronic Platform
for Enhanced Information Management” At A Public Hearing
For The United States Food And Drug Administration (FDA)
Washington,
DC (December 18, 2006) – ThinSpring, a leading provider
of XML-based solutions such as SPL Server™ and the
FDA’s Electronic Labeling Information Processing System
(ELIPS), has been selected to present “Electronic Submission
of Regulatory Information: Creating an Electronic Platform
for Enhanced Information Management” at a public hearing
to the United States Food and Drug Administration (FDA).
The presentation will be given by Ron Celeste, CEO of ThinSpring,
on December 18, 2006, in Washington, DC.
Mr. Celeste will begin by giving a historical perspective
of eSubmissions with a review of the major milestones that
have shaped the way the life sciences industry deals with
electronic submissions for regulatory compliance. Mr. Celeste
will then take the presentation into the near future and
outline the events that will shape the industry in the years
to come. Some of the future events he will discuss include
the HL7 Stability Data Standard and the upcoming eCTD mandate.
The presentation will include a review of the industry standards
landscape, implications for the IT infrastructure, a discussion
of submission lifecycle management, and the facilitation
of third-party electronic submissions. Mr. Celeste will end
the presentation with a discussion of the industry challenges
and open the discussion to questions from the audience.
The FDA currently uses ELIPS as a part of the process to
receive, internally validate, store, approve and transmit
SPL submissions from pharmaceutical manufacturers. From the
experience of developing ELIPS, ThinSpring is able to provide
effective and reliable XML submission and structured data
management solutions.
For more information, go to the ThinSpring website or contact
Earl Pendleton at (919) 654-4535.
About ThinSpring:
ThinSpring, founded by former pharmaceutical and medical device professionals,
specializes in XML web-based solutions, integration and data conversion. ThinSpring
has used its industry expertise to develop a dynamic XML engine, MatriXML™.
This patented XML technology is the basis for all ThinSpring solutions including
XML Sage, SPL Server, PIM Server, and eCTD Server. ThinSpring’s solutions
have gained acceptance as an essential, collaborative application-development
platform for FDA regulated companies. ThinSpring’s core team manages technology
and regulatory consulting divisions that support its clients’ operations
throughout the United States, Europe, Asia and South America. ThinSpring headquarters
is in Bridgewater, New Jersey, with offices in California and North Carolina.
More information about ThinSpring and ThinSpring’s solutions can be found
on their website at: http://www.ThinSpring.com.
Media Contact:
Ron Celeste
ThinSpring
908-962-0740
ron.celeste@thinspring.com
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