DITA Pharmaceutical Content Subcommittee

DITA TC Minutes 2009-05-26: Formation of Subcommittee for Pharmaceutical Content

New Item

Proposal to initiate the formation of an OASIS DITA Pharmaceutical Content Subcommittee (DITA-PC-SC)

Background

http://lists.oasis-open.org/archives/dita/200905/msg00032.html (Steffen Frederiksen)

Steffen Fredericksen provided background about the rationale for starting the new subcommittee. Pharmaceutical companies are struggling with multiple government regulatory standards being imposed. Information has to be delivered in various formats, including SPL structured product labeling format, Product Information Management (PIM) for the European Union, ECDD for FDA approval and more. All of these standards are rendition standards, but none suited to be a common, backbone standard for storing, editing, and working with the data. Quality of documentation is absolutely essential for the industry.

The timing is essential; there is lots of work currently being done on common standards, thus the right time to introduce DITA. As of 25-May-2009, he has mailed (to OASIS) a list of 27 people from pharmaceutical companies who have given an initial yes to particpation; 11 other people are considering participating. Has the beginning of a charter, but wants the newly-formed SC to work on the charter.

Don Day clarifies that a completed charter is necessary to initiate the SC, but the SC can then flex it out more completely. Items required are a name, statement of purpose, list of deliverables, and name of chair. Steffen stated that they will have two co-chairs, himself and James Averback.

Nancy Harrison asked whether the information that the pharmaceutical companies generates contains the results of clinical trials, and then commented that there is an overlap with medical records. Steffen stated that the subcommittee would begin with the core area of submissions. Don Day suggested that the subcommittee add a roadmap to their work items.

Steffen Fredericksen proposed that the TC approves the creation of the subcommittee; seconded by Anne Rockley; approved by acclamation.

[...]

Source: Minutes of DITA TC meeting May 26, 2009

Prepared by Robin Cover for The XML Cover Pages archive. See also the main entry OASIS DITA Pharmaceutical Content Subcommittee.

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