ICH E-6 GCP Proposed Revisions 2016 Review: Impact on Sites, Sponsors, and CROs

Upcoming Courses
Course #: BI12647
July 28, 2016
9:00 AM - 11:30 AM Eastern
Course #: BI12648
August 29, 2016
9:00 AM - 11:30 AM Eastern
Course #: BI12543
October 5, 2016
9:00 AM - 11:30 AM Eastern
Course #: BI12615
December 7, 2016
3:00 PM - 5:00 PM Eastern

Course Description

For the first time in 20 years, the International Conference for Harmonization (ICH) E-6 Good Clinical Practice (GCP) Guideline is being updated. The proposed revisions are intended to modernize and encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. But, the proposed changes have resounding effects and impact on Sponsors and Investigators, requiring a complete and systematic analysis to ensure adherence to these proposed clinical trial standards. This web seminar not only informs learners of the proposed changes, but also provides information and techniques for a constructive and systematic approach in assessing organizational practices and designing any modifications.

Learning Objectives

  • Identify three changes impacting Investigator and Sponsor responsibilities
  • Explain the impact of the proposed revisions to three organizational practices
  • Evaluate presented solutions for applicability, use, modification for proactive assessments of organizational practices, processes, procedures, and staff training

Who Should Attend

  • Managers/Directors: Clinical Operations, Clinical Research, Data Management, Quality Management, Compliance, Process Improvement, Risk Management, Quality Risk Management
  • Study Managers and Monitors (Centralized, On-site)
  • Clinical Research Associates and Project Managers
  • Quality Assurance Personnel
  • Investigators and Study Coordinators
  • Directors: Clinical Trial Unit, Clinical Trial Offices
  • Office of Research Compliance and Risk Management Personnel


Liz Wool, R.N., B.S.N., C.C.R.A., CID, CMT

Click here for complete trainer biographies

Registration Fees


Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2.5 hours (0.25 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-16-051-L01-P. Released: 7/16. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.