Regulatory Open Forum

 View Only

  • 1.  ICH E8 (R1)

    Posted 03-May-2022 13:22
    Hi All,

    We conducted an audit to confirm our compliance with the then upcoming (now released) ICH E8 R1 guidance in September 2020. Now we are trying to see if any changes were made between that time and October 2021. Do any of you know of a way to do this? I don't see a revision history that goes into that much detail, or anything to show the changes.

    Thanks,
    Ellen

    ------------------------------
    Ellen Dark
    Quality Assurance Senior Analyst
    Waltham MA
    United States
    ------------------------------


  • 2.  RE: ICH E8 (R1)

    This message was posted by a user wishing to remain anonymous
    Posted 11-May-2022 10:15
    This message was posted by a user wishing to remain anonymous

    Hi Ellen

    One option is to save both documents as plain text (use copy and paste). Then use Microsoft Word's Compare Documents function. It's kludgy, and it doesn't help as much if there's major reorganization, but it's often good enough to show you where to look closer.
    Original Message


  • 3.  RE: ICH E8 (R1)

    Posted 12-May-2022 09:49
    Dear Ellen,

    You may want to review the annex 1 of meeting summary for specific guideline revision recommendations, but if you have a PDF copy of the previous ICH E8 R1 version, you can compare the PDF files in Acrobat following the instructions in: https://www.adobe.com/acrobat/how-to/compare-two-pdf-files.html

    Best,


    ------------------------------
    Juliane Carvalho RAC, MSc
    Lead Regulatory Health Project Manager
    United States
    **My comments are an informal communication and represent my own best judgement. These comments do not bind or obligate the U.S. Food and Drug Administration**
    ------------------------------

    Original Message


Related Content