2019-07-18 ARB Agenda/Minutes

Catherine and Smita here to review PSS and external material.  Scope of the project covers the domain of Pharmaceutical Quality/Chemistry, Manufacturing and Controls. US Realm asked them to change the name from PQ/CMC to something more descriptive rather than just an acronym. FDA has regulatory needs in receiving structured and standardized data in pharmaceutical quality. Smita reports that the FDA material was brought in to create FHIR material that was developed in cooperation with BR&R. The material has changed as the work with BR&R has continued. Decision that since the actual work beyond domain requirements has been or will done in conjunction with BR&R and the FHIR team, the resulting material is not external.

MOTION that ARB, in consultation with the project team, is satisfied that appropriate work with the WG has occurred, and this is no longer classified as external content.

Ron/Jeff

6-0-0

Reviewed recent updates. Has not had any more feedback from HTA. Need to start discussing this with product family methodology groups, but would like TSC to take a look first. Lorraine notes the relationship to the TSC work on coming up with a third realm designation.

What is the ask from the TSC? Ron would like them to do an overview and vote on whether they like the intent and whether it is logical to move forward.

Ron would like ARB members to review/provide any feedback as well before moving to methodology groups.

Lorraine asks people to review and determine if ARB needs to weigh in on two items from TSC:

First item is the US Core and Profile Development. 

Second item is a Versioning Precept (draft) from the SGB