Meeting Minutes from Discussion
Decision Link(if not child)
Approve minutes from April 28th
Accepted by general consent
May WGMDraft agenda
Time needs to be finalized for the items in red.
Hugh suggested BR&R might run a session after the Virtual WGM looking at present pharma thinking in light of COVID-19.
|Some interest in BR&R being an INterested Party. Need to determine if falls under Patient Care.|
26570: Proposed to change MedicinalProduct references to CodeableReferences. Rik proposed, Peter second, no objections, no abstentions, 9-0-0.
26670: Proposed to make only status mandatory. Rik/Craig, no objections, no abstentions, 9-0-0.
26669: Proposed to eliminate the "product" tautology from productClassification, Rik/Peter, no objections, no abstentions, 9-0-0.
26989: Proposed to eliminate redundancy by removing dose-form from AdministrableProduct since already recorded under MedicinalProduct. Rik/Craig, no objections, no abstentions, 9-0-0.
Regulatory related JIRA tickets - Peter Bomberg
FHIR-26860 - Add RegulatedAuthorization to the CodeableReference list in Procedure.reason.Reference.
FHIR-26861 - Usage question relating to basedOn and partOf
26861: Need to clarify the distinction between a partOf multi-stage inspection and a repeated inspection based on the failure of the first one.
26862: Depending on the duration of the Procedure, it may nor may not need a status variable recorded (e.g. a lengthy rehabilitation.)
26648: Already resolved.
25961: Refers to the authorization of regulatory activities, not medicinal product. Other steps already mapped, only activities and fees left. Need to specify what the fee is associated with (a plan or an authorization). Alternatively, could be done through an extension.
25943: Not only an Organization but also a practitioner can be a marketing authorization holder. A person would still be treated as a license holding organization. Don't need to change the reference to Organization, but need to clarify that the marketing authorization holder can be a holder (not for drugs but, e.g., for shipping facilities). Change accepted with 9-0-0.
|Postponed until next meeting|
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