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| Upcoming ISO Standard for Electronic Submission of Stability Data Norbert Bittner up to data professional services, Wörrstadt (Germany) FDA, Clinical Data Interchange Standardisation Consortium (CDISC) and other industry representatives work together in the ANSI (Ame-rican National Standardisation Institute) accredited standardisation organisation HL7 (Health Level 7). Within this organisation the Technical Committee on Regulated Clinical Research Information Management (RCRIM) creates data standards in the field of pharmaceutical reasearch and drug evaluation. A standard for the exchange of stability data was approved in May 2005, and FDA and domain experts are currently working on a detailed implementation guide. European regulatory authorities are already evaluating the HL7 standards to incorporate these standards in future projects. |
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pharmind 2005, Nr. 7, Seite 765
