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)
ThinSpring 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) on December 18, 2006.
Washington, DC (PRWEB) 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-based Web service 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 SPL 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 SPL Server™ can be found on their website at: http://www.ThinSpring.com.
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