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PIP compliance check during validation after MAA submitted or before MAA submission through PDCO

  • 1.  PIP compliance check during validation after MAA submitted or before MAA submission through PDCO

    Posted 23-Aug-2017 12:34
    Hello,

    Fo​​r anyone with experience with the PIP process and MAA submissions, does anyone have experience they can share about having EMA check that the measures in the PIP are met, just after an MAA is submitted? If you followed this path, were there any delays/risks in validation due to this?

    There is also an option of requesting a PDCO-coordinated compliance check prior to MAA submission (See guidance below): 

    Applicants may request the PDCO to confirm compliance in advance of their Regulatory Applications; this can be done sequentially, in stages, (see Q&A 8 above). Applicants can alternatively choose to submit their marketing authorisation application (or other Regulatory Application) without having previously obtained a compliance check; in this case, compliance will be checked as part of the validation procedure.


    If anyone has experience with either strategy or even both, I would love to hear how the process worked, what documents were expected to provide, and what hurdles you may have encountered.

    Tom

    ------------------------------
    Thomas Demelfi
    Director, Regulatory Affairs
    Atara Biotherapeutics
    Westlake Village CA
    United States
    ------------------------------


  • 2.  RE: PIP compliance check during validation after MAA submitted or before MAA submission through PDCO

    Posted 24-Aug-2017 09:01

    Hi Thomas,

     

    Depending upon how many binding elements you have in your PIP, the compliance check can be quite complicated.  If possible, I would highly suggest to complete the PIP compliance check before submitting the MAA so that this does not become a critical path item to pass validation and start the review clock.

     

    The challenge becomes having the source documentation ready to submit to PDCO with the compliance check.  PDCO indicates that it prefers final documents, but this can be a challenge in getting final Clinical Study Reports ready 3 months prior to the MAA submission.  I have typically submitted final drafts of the body of the CSR with the compliance checklist, annotating the check list to the source document(s).

     

    Good luck!

     

    Mark

    __________________________

     

    Mark A. De Rosch, PhD

    Senior Vice President,

    Regulatory Affairs, Quality Assurance, and CMC

    Akebia Therapeutics, Inc.

    245 First Street, 14th Floor

    Cambridge, MA 02142

     

    Office: (617) 871-1214

    Cell: (603) 714-5079

    Main: (617) 871-2098

    Fax: (617) 871-2099

    Email: MDeRosch@Akebia.com

    Web: www.akebia.com

    image001.png@01CF345F.B6E98B10

     

     




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