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Inspections and Audits

Home » Topics » Clinical Trials » Inspections and Audits
  • June 14, 2018

    MHRA Cites Data Management and Integrity in GCP Inspections

    Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
  • June 4, 2018

    MHRA Cites Data Management, Integrity Issues in GCP Inspections

    Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products.
  • January 18, 2018

    ANSM Creates New Unit to Handle Early Stage Clinical Trials

    France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials.
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  • December 27, 2017

    ANSM Creates New Unit to Handle Early Stage Clinical Trials

  • December 12, 2017

    ANSM Creates New Unit to Handle Early Stage Clinical Trials

  • March 10, 2016

    Clinical Investigator Lands Warning Letter for Enrolling Pregnant Subject

  • December 14, 2015

    FDA Raises Alarm Over Unauthorized Clinical Trial

  • October 8, 2015

    Report Outlines Strategies for Risk-Based Monitoring

  • September 10, 2015

    Trial Investigator Warned Over Lack of SOP Documentation

  • June 11, 2015

    Device Trials Program Overhaul Aims for Speed, Consistency: FDA

  • June 11, 2015

    21st Century Cures Act Sails Through House Committee

  • May 7, 2015

    Expert Advises on Risk-Based Monitoring in Clinical Trials

  • May 7, 2015

    FDA Reduces Clinical Hold On Tekmira’s Ebola Drug

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Events

  • 24May

    Powering an Effective Oversight Strategy with Clinical and Operational Insights

  • 25May

    2022 WCG Avoca Quality & Innovation Summit: Own the Future

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