XML Initiatives in Pharma

Track: Vertical Industries

Audience Level: High Level/Technical view

Time: Wednesday, November 16 14:00

Author: Dale Waldt, aXtive minds

Keywords: XML, SPL, USPI, Pharamceutical


The pharmaceutical industry has been slow to adopt XML until recently. Initiatives in the US and EU, as well as other jurisdictions, have begun that use XML to define important documentation formats as part of the drug product life cycle. In the US the FDA is mandating that drug product descriptions called "labels" be submitted in an XML format called the Standard Product Label (SPL) language by the end of 2005 and similar mandates are being made in the EU and other regions. Since most pharmaceutical companies are international, companies are scrambling to figure out the best method for managing their data in order to meet all of meeting these specific requirements. Also, drug label information will become an important component in the broader set of medical records and prescription standards that are being developed concurrently. This session will describe the roles and status of these standards, initiatives for adoption in the US and the EU, and provide some ideas on strategies for managing data within this complex set of requirements.