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    Day 3

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    bhavik poshiya

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    Day 3

    Uploaded by

    bhavik poshiya
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    DAY-3

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    Day 3

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    of 2

    3/2/22, 5:01 PM GEM 3.

    9 | Dashboard

     GCP Day 1  GCP - Day 2  GCP - Day 3

    12:30 — 12:45

    Day 3 Welcome
    Stephen Vinter, Head of GLP/ Laboratories, MHRA

    12:45 — 13:05

    Opening remarks and keynote address


    Dr. Carole Légaré, Director, Office of Clinical Trials, Therapeutic Products Directorate (TPD), Health Products
    and Food Branch, Health Canada

    13:05 — 13:40

    Session 1 - Issues and challenges identified within the clinic


    (Moderators – Scott Appleton, Ph.D. & Leslie Vrooman, MSc., DBE/TPD/HC)

    Emma Whale, Senior GCP/GLP Inspector, MHRA

    13:40 — 14:45

    Session 2 - Issues and challenges within the Bioanalytical Laboratory


    (Moderator – Stephen Vinter, MHRA)

    Data Integrity Violations in BA/BE Studies - Case studies presenting key data integrity issues from data
    submitted to the FDA
    Effective use of guidance - A presentation discussing common inspection findings where laboratories have
    failed to follow recognised bioanalytical guidance.
    Internal Standard response monitoring - Case Studies from data submitted to Health Canada highlighting the
    importance of monitoring performance and evaluating trends.
     

    Arindam Dasgupta, Ph.D., , Deputy Division Director, OSIS/FDA


    Michael McGuinness, Senior GLP & GCP Inspector, MHRA
    Susan Stojdl, MSc., , Senior Clinical Assessment Officer, DBE/TPD/HC

    14:45 — 15:05

    Break

    15:05 — 16:00

    Session 3 - Regulatory updates


    (Moderator – Julia Cho, Ph.D., FDA)

    An overview of and update on the draft ICH M10 Bioanalytical Method Validation Guideline
    https://mhra-good-practice-symposia.co.uk/home/community/agenda 1/2
    3/2/22, 5:01 PM GEM 3.9 | Dashboard

    An update on FDA’s inspections and use of remote activities for bioavailability and bioequivalence studies
    submitted in U.S. drug and therapeutic biologic applications
    An update on the current and future inspection approaches for studies submitted to the MHRA
     

    Dr. Anna Edmison, Ph.D., Senior Clinical Assessment Officer, DBE/TPD/HC


    Stephen Vinter, Head of GLP/ Laboratories, MHRA
    Sean Kassim, Ph.D.,, Office Director, OSIS/FDA

    16:00 — 16:45

    Panel discussion
    (Moderator- Lina Alshobly, MSc, CTCP/HC)

    16:45 — 17:00

    Wrap-up and Closing Remarks


    Laurie Muldowney, M.D., , Deputy Director, OSI/FDA

    Copyright © 1987-2022 Glasgows. All rights reserved.

    https://mhra-good-practice-symposia.co.uk/home/community/agenda 2/2

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