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

[Steffen Frederiksen <srf@dita-exchange.com>]

BACKGROUND:

As mentioned in our last DITA TC meeting, I hope to be able to put forward a motion to initiate the creation of an OASIS DITA Pharmaceutical Content Subcommittee in the meeting on May 26th. 

To support the discussion of this motion - and following the advice of Don, I have included the preliminary statement of purpose as well as ATTACHED a DRAFT (obviously for your information only) version of a charter for the potential SC.


PRELIMINARY STATEMENT OF PURPOSE:

The OASIS DITA Pharmaceutical Content Subcommittee (DITA-PC-SC) will define DITA topics, maps, associated metadata properties and terminology to streamline design and creation of the complete body of pharmaceutical documentation required to present a product for scientific and regulatory purposes throughout its lifecycle.
These constructs will include a pharmaceutical content taxonomy of DITA topics, the metadata and terminology to be associated with each topic instance and a taxonomy of DITA maps all of which are defined to optimize reuse and re-purposed content. Initial objectives are to define topics and maps as required to implement: 
a)    the ICH Common Technical Document content specification; and, 
b)    the FDA Structured Product Labeling and 
c)    EU Product Information Management content specifications.  

Deliverables from this SC will include:
1.	A set of best-practice recommendations on how to implement the DITA standard content architecture in the pharmaceutical industry
2.	A series of map, topic, and metadata templates along with a systematic taxonomy of pharmaceutical content
3.	A submission of draft specifications of required pharmaceutical DITA specializations to the main DITA TC 


TENTATIVE PARTICIPANTS:

At this moment, we have tentative participants from these companies: Pfizer, J&J, Merck, Wyeth, Amgen, Novartis, ISI, Paragon, Sapient, SeicoDyne, speakTECH, LSCP, Glemser, MedImmune, Sanofi Aventis, Lorenz, Elan, Microsoft, LSIP, and Content Technologies.

I hope to be able to provide more information in the meeting.


LIAISONS WITH THE MAIN DITA TC

Two voting members of the main DITA TC have indicated that they will participate in the new SC:
1.    Chris Kravogel, SeicoDyne, and
2.    Steffen Frederiksen, Content Technologies


INITIAL MEETING OF THE PROPOSED SC

We will be working toward an initial meeting of the potential SC in June, before the holiday season starts.
LSIP/James Averback (who has contributed very significantly to this process) has offered to provide teleconferencing facilities for the SC
Steffen Frederiksen can be the meeting convener.



Best Regards
>< Content Technologies ApS
Steffen Frederiksen
Director, Co-founder
Katrinebjerg Science Park | Aabogade 15 | DK-8200 Aarhus N | DENMARK | Cell: +45.4044.0553 | Fax: +45.6980.3578 | srf@dita-exchange.com

OASIS_DITA_Pharmaceutical_Content_Subcommittee_DRAFT_Charter.pdf