ICH-GCP & Principles of ICH GCP- E6 and E6(R2) Poster Presentation By Steeve Branden Wood

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  • Опубликовано: 3 дек 2024

Комментарии • 8

  • @janinejansen1263
    @janinejansen1263 2 года назад

    Excellent, easy to follow presentation. Thank you very much.

  • @kaustubhrege969
    @kaustubhrege969 2 года назад

    Thank you sir for your guidance.

  • @devikanaidu3846
    @devikanaidu3846 2 года назад

    Thank you so much. Very helpful

  • @shirinshaik4468
    @shirinshaik4468 2 года назад

    Hi.... Tq it's very helpful for me.... Ur explanation is very good 😍😍... I have a doubt can anyone plzz explaned about it if u knows???? In history of dis presentation.... Requirement for ethical committee approved by IRB in 1971 ..???? But the IRB is formed july 12,1974....???? Is their any information about it

    • @ClinimindsIndia
      @ClinimindsIndia  2 года назад +1

      The U. S. Department of Health, Education, and Welfare issued ethical "guidelines" in 1971 which were "codified into Federal Regulations" in 1974 as 45 CFR 46.
      Guidelines are basically suggestions which tell you how to do anything, whereas codification is the act or process of arranging something, such as laws or rules, into a system. The U.S. Code is a codification of all statutes passed by Congress.Without codification, there is no guarantee that the policy will remain consistent
      Codification helps 2 basic purposes:
      1) Certainty - By Codification, law becomes certain. It no longer remains vague and uncertain.
      2) Simplicity- The codification makes law simple and by this simplicity it makes it easy and accessible to everybody.
      This central set of regulations is known as the Common Rule, because most other federal agencies also rely on them as the primary set of requirements related to IRB operations and research review. However, the primary impetus for current government ethical regulation began with the establishment of a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research under the aegis of the Department of Health, Education, and Welfare in 1974. Since, the guidelines were still evolving at the time, hence it took some time to convert those guidelines into law.
      Thanks,

      Head - Academics,
      Tenet Health Edutech Pvt. Ltd.

    • @shirinshaik4468
      @shirinshaik4468 2 года назад

      Thank you so much sir

  • @srikakolapuramya2457
    @srikakolapuramya2457 2 года назад

    Difference between ethical principles and GCP principles?
    Can u pls tell the ans

    • @ClinimindsIndia
      @ClinimindsIndia  2 года назад

      Kindly share your contact details with us to connect you to the concerned department. Feel free to call us at 9310485978, 9560102589. Write to us at info@cliniminds.com. www.cliniminds.com