Date: 17 - 19 October 2017
Location: Harvard University, Cambridge, MA, USA
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.
This three day training program is free to attend but space is limited!
Please click here to find out more and to apply.
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.