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  1. FHIR Specification Feedback
  2. FHIR-43817

Use of EDQM terminology for 2 elements with preferred binding in UV Realm

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    • Icon: Change Request Change Request
    • Resolution: Not Persuasive
    • Icon: Highest Highest
    • Pharmaceutical Quality (Industry) (FHIR)
    • current
    • Biomedical Research & Regulation
    • STU
    • Medicine Dose Form EDQM
    • 6.0.20
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      We prioritize international standards where they exist. In this case, ISO IDMP is the relevant international standard. It has designated EDQM as the standard for dose form, route of administration, unit of presentation, pack type, closure type. Therefore, to maintain alignment with IDMP, this IG will reference EDQM as the preferred terminology for the aforementioned topics. 

      This has the added benefit of supporting industry’s intended use case for data alignment/reuse across PQ, clinical, ePI, artwork, and defect reporting to name a few. This also facilitates industry’s implementation since most regulatory information management (RIM) software developers are already pre-loading their systems with this terminology to facilitate compliance with the EMA’s IDMP implementation through their SPOR program. 

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      We prioritize international standards where they exist. In this case, ISO IDMP is the relevant international standard. It has designated EDQM as the standard for dose form, route of administration, unit of presentation, pack type, closure type. Therefore, to maintain alignment with IDMP, this IG will reference EDQM as the preferred terminology for the aforementioned topics.  This has the added benefit of supporting industry’s intended use case for data alignment/reuse across PQ, clinical, ePI, artwork, and defect reporting to name a few. This also facilitates industry’s implementation since most regulatory information management (RIM) software developers are already pre-loading their systems with this terminology to facilitate compliance with the EMA’s IDMP implementation through their SPOR program. 
    • Diana Wright / Rob Hausam: 12-0-0

    Description

      In Section 6.0.20 – Noticed that 2 of the elements are bound to EDQM terminology as a preferred binding. Considering that this is a UV Realm IG, would have expected to see EDQM as an example binding similar to the terminology binding in Closure Type.

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            Unassigned Unassigned
            mrocca Mitra Rocca
            Norman Gregory, Scott Gordon
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