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    Q1-Q5C - EWG WorkPlan - 2023 - 0301

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    Raj Sweet
    The document outlines the work plan for revising the ICH Q1/Q5C guideline, including key milestones, timelines for tasks, and details of drafting and reviewing activities by sub-teams and constituencies through 2023.

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    Q1-Q5C - EWG WorkPlan - 2023 - 0301

    Uploaded by

    Raj Sweet
    14 views2 pages
    The document outlines the work plan for revising the ICH Q1/Q5C guideline, including key milestones, timelines for tasks, and details of drafting and reviewing activities by sub-teams and constituencies through 2023.

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    Q1-Q5C_EWG WorkPlan_2023_0301

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    The document outlines the work plan for revising the ICH Q1/Q5C guideline, including key milestones, timelines for tasks, and details of drafting and reviewing activities by sub-teams and constituencies through 2023.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    14 views2 pages

    Q1-Q5C - EWG WorkPlan - 2023 - 0301

    Uploaded by

    Raj Sweet
    The document outlines the work plan for revising the ICH Q1/Q5C guideline, including key milestones, timelines for tasks, and details of drafting and reviewing activities by sub-teams and constituencies through 2023.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    ICH Q1/Q5C EWG Work Plan

    March 01, 2023

    Topic Adoption date: June 2022


    Rapporteur: Ms. Megan McMahon, PhRMA
    Regulatory Chair: Dr. Ashutosh Rao, FDA, United States
    Last Face-to-Face Meeting: Incheon, Republic of Korea, November 2022

    1. Key milestones

    1.a. Current status of key milestones


    Past
    completion date Milestone
    Nov. 2022 Concept paper endorsement
    Nov. 2022 Business plan endorsement
    Nov. 2022 Establishment of EWG

    1.b. Future anticipated key milestones


    Expected future
    completion date Milestone
    Dec. 2024 Step 1 Sign-off
    Dec. 2025 Step 4 Adoption, Completion of Training Materials

    2. Timeline for specific tasks

    Beginning End
    date date Task / Activity Details
    Dec. 2022 Feb. 2023 Define Guideline Sub-teams identify what initial content
    revisions/initial drafts to drafts will be available for constituency
    be completed Q1 2023. review by May 2023.

    1
    Dec. 2022 Feb. 2023 Deliver EWG aligned TOC. Alignment on organization of proposed
    revision, including how to integrate
    guidelines and manage annexes.

    Feb. 2023 Mar. 2023 Section authoring by sub- Sub-teams will author sections in
    teams, consulting as parallel, bringing drafted text to EWG
    needed with EWG. for broader review/input.

    Mar. 2023 Apr. 2023 Sub-teams collect and Sub-teams work to address EWG
    address EWG feedback on feedback on completed text. Prepare
    initial section drafts. initial draft sections for internal
    constituency review.
    May. 2023 May. 2023 Constituency review of Drafted components will be provided for
    initial drafts of internal constituency review. Feedback
    revised/new sections. will be requested by end of May.

    May. 2023 Jun. 2023 Organize feedback into Identify feedback that requires
    major and minor items. discussion by the full EWG and feedback
    that may be managed at sub-team
    level.
    Jun. 2023 Jul. 2023 Discuss and address Sub-teams will address minor feedback
    stakeholder feedback to sections. Feedback with broad
    impact will be addressed within the
    EWG.

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