Minnesota: ICH GCP E6 R2 Revisions: Impact on the PI and Site

When:  Sep 19, 2017 from 05:30 PM to 08:00 PM (CT)
Associated with  ACRP Upper Midwest Chapter

ICH GCP E6 R2 Revisions: Impact on the PI and Site

  • Lionel Lewis, MD, MA, MB-BCH
  • Erika Stevens, MA
  • Liz Wool, RN, BSN, CCRA, CID, CMT
Registration Fees:
  • MN Chapter Members: $0 with contact hours, $0 without contact hours
  • ACRP Members: (non chapter members): $25 with contact hours, $10 without contact hours
  • General Public: $50 with contact hours, $20 without contact hours
Program Description: This program addresses the updates to the International Conference for Harmonization (ICH) Good Clinical Practice (GCP) E-6 Guideline. The proposed revisions will modernize and encourage implementation of more efficient approaches to clinical trial design, conduct, oversight, documentation, and reporting, as well as human subject protections. This session reviews the changes and clinical research practices impacted by the new requirements that serve both as the starting point for an organization’s gap analysis, and the subsequent re-design of work practices for compliance with the ICH GCP E6 R2. It engages participants in hands-on gap analysis training. Participants will be able to determine both the impact of these updates and solutions for PI-site practices.

The relevant target audience for this program is all clinical research and regulatory affairs professionals, whether at sites, CROs, IRBs, compliance organizations or medical product companies.

Upon completion of this presentation, participants should be able to:
  • Describe two influencing factors for the revisions
  • Analyze three changes impacting investigator-site responsibilities when compared to the current ICH GCP E6 Guideline
  • Evaluate gap analysis areas/topics to develop an action plan for promoting compliance with the proposed revision
Program Agenda
5:30 – 6:00 Registration and Buffet Dinner
6:00 – 8:00 Educational Presentation and Discussions

Contact Hours: 2 contact hours have been applied for through ACRP. Membership is not required for online registration of contact hours.

To Receive Contact Hours: Purchase the contact hours, sign in at the registration desk and attend the program. Log on to the ACRP website and go to “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Refund/Cancellation: If you need to cancel your registration, please notify the Programming Committee as soon as possible but no later than 24 hours prior to the event for a full refund. Email acrpmnchapter@gmail.com to cancel and request a refund.


3001 Broadway Street NE, Minneapolis, Minnesota 55413 (follow posted signs to meeting area)