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ICH Good Clinical Practice (GCP) Training

Focus Area: Training

ICH Good Clinical Practice (GCP) Training

Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide wish to ensure that drugs, biologics and devices are developed by processes that uphold the highest ethical standards and scientific principles.

These processes depend upon consensus understanding of the principles underlying drug development, clinical and research practices, regulatory review of submitted data, regulatory inspections and post-approval monitoring.  Further, evolving technologies, capacities, and study design require periodic review and adaptation of the ICH guidelines. Harmonized technical guidelines to which global regulators commit can speed the process for efficient and effective registration, approval, and monitoring.  The development of these technical guidelines is best achieved through close collaboration between regulatory authorities and pharmaceutical industry representatives. A shared interpretation of these guidelines is essential to a cooperative and global effort to promote and protect public health.

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has recently endorsed a training effort to help ensure greater adoption of  ICH guidelines by regulators and industry. The MRCT Center has been selected to conduct a pilot training in 2017.

The MRCT Center established a multi-stakeholder program committee and is planning to conduct the first pilot training of regulators from emerging economies October 17-19, 2017 at Harvard Faculty Club.

Current status

Active project

Impact

Improved regulatory capacity to provide a unified standard for conducting clinical trials.

Learning Objectives

  • Describe the standards of Good Clinical Practice (GCP) as set out in ICH E6 as well as the changes in the ICH E6(R2) revision, as applied to multinational design, conduct, oversight, reporting and review of regulated trials
  • Describe models of implementation of the changes in the ICH E6(R2) addendum
  • Demonstrate practical approaches to fulfilling the requirements of ICH E6(R2) consistent with revised standards (e.g., risk-based quality management)
  • Describe and demonstrate best practices to assess clinical trial regulatory submissions, including study design, data packages, essential documents, reports, and filings for alignment with ICH GCP
  • Define inspection methodologies to assess clinical trial conduct for alignment with ICH GCP including review of corrective actions.

Key Milestones

  • May 2017: First planning committee meeting for ICH E6(R2) pilot training
  • June 2017: Application process opened
  • October 2017: ICH GCP Pilot Training at Harvard Faculty Club

Program Manager: Carmen Aldinger