ICH GCP Training at Harvard University, October 17-19, 2017
Consistent with the goals of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), regulatory authorities worldwide aim to ensure that drugs are developed by processes that uphold the highest ethical standards and scientific principles. Those developing and conducting high quality clinical trials 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. Harmonized technical guidelines to which global regulators commit can speed the process for efficient and effective registration, approval, and monitoring. A shared interpretation of these guidelines is essential to a cooperative and global effort to promote and protect public health.
That said, clinical research and clinical trials are not stagnant. The evolution of research technologies (e.g. electronic data sources, risk-based monitoring) and study design (e.g. adaptive trials) render periodic review and adaptation of the ICH guidelines necessary. In December 2016, a comprehensive revision of ICH E6, termed ICH E6(R2) was adopted; ICH E6 was "amended to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting while continuing to ensure human subject protection and reliability of trial results." It is important that the international regulatory community understand the changes in the ICH E6(R2) addendum, share a common interpretation, and are familiar with approach and implementation.

ICH Training Program Hosted by MRCT Center of Brigham and Women's Hospital and Harvard University
This ICH training program is a workshop specifically designed for regulators with responsibility for drug review and approval. The workshop goals are to advance the understanding of the ICH E6 guidelines, with a particular emphasis on the new and revised ICH E6(R2) guidelines to facilitate their adoption and implementation. Case-based learning, presentations, and open discussion of scientific, statistical, and practical approaches will be used. The Faculty will include regulators from the USFDA, EMA and others with the assistance of academic and industry leaders. All sessions will be conducted in English.
When: October 17-19, 2017
Where: Harvard University, Cambridge, MA USA
Learning Objectives for ICH GCP Training Program
  • 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.
Wherever possible, use of case studies and active learning modalities will be employed.

This course is free to attend, but individual participant expenses other than registration will not be covered.

Attendance at all three days is necessary, and a certificate of completion will be awarded.

An agenda is forthcoming.

Because space is limited, please fill out the following application.