Regulatory Open Forum

 View Only

  • 1.  Australia - Authorized Prescriber Protocol

    Posted 29-May-2019 18:16
    Hello everyone, 

    I am currently working on an authorized prescriber (AP) HREC application for a total hip arthroplasty (THA) system not yet approved in Australia.  The system allows the surgeon better options than predicate devices when performing direct anterior THA. The surgeon has requested to use the AP pathway pending our TGA approval. I have reviewed the regulations and understand that it requires a protocol demonstrating safety, efficacy, and monitoring of AE's. My question is, does anyone have an example of an AP application for the HREC?

    Any guidance/assistance would be appreciated. 

    Thanks, 

    Mike

    ------------------------------
    Mike Anderson
    Director of Clinical and Regulatory Affairs
    Draper UT
    United States
    ------------------------------


  • 2.  RE: Australia - Authorized Prescriber Protocol

    Posted 04-Jun-2019 11:51
    Edited by Lillian Erickson 04-Jun-2019 11:51
    Hi Mike. I found this resource, which I'm sure you're already aware of, and may not be as precise as you were hoping for, but thought I would post it here for future readers. 

    https://www.australianclinicaltrials.gov.au/industry-and-sponsors


    ------------------------------
    Lillian Erickson
    Regulatory Affairs
    Lake Point UT
    United States
    ------------------------------

    Original Message


Related Content