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Pierre Bonsergent

Pierre Bonsergent

Joined: 6/4/2024

  • Forum Posts
  • RE: PIP - Full waiver: Completion of Scientific information section in IRIS

    Mon, 19 May 2025 13:53:02 GMT – PIP - Full waiver: Completion of Scientific information section in IRIS
    Dear Paolo,
    Many thanks for your kind feedback. 
    It is indeed due to the wrong classification of the submission type. All fixed.
     
  • PIP - Full waiver: Completion of Scientific information section in IRIS

    Mon, 19 May 2025 12:27:52 GMT – PIP - Full waiver: Completion of Scientific information section in IRIS
    Dear IRIS colleagues,

    I am currently looking for some support to populate 2 parts of the section on "Scientific Information" in IRIS for a PIP where a (full) waiver is requested for all subsets of the paediatric population:
     
    1. Proposed date for completion of the PIP (must be the date of completion of the latest study/measure, or later) --> As a full waiver is requested, no measures are proposed for full waiver PIP. As you cannot put "NA" in this field, could you please let us know if putting 01/01/1900 is acceptable?
    2. Please provide details on each proposed study/measure (at least one), including appropriate key elements --> As above, no measures are proposed for a full waiver PIP. As the system is still requiring to populate this section, could you please inform what type of information should be provided there?
    Many thanks in advance for your kind support.
     


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