Southeastern Michigan: How Does the Recent ICH-GCP E6 Update Affect YOU?

When:  May 30, 2017 from 04:00 PM to 06:00 PM (ET)

HOW DOES THE RECENT ICH-GCP E6 UPDATE AFFECT YOU?

Program Agenda:
  • 4:00 - 4:30 pm - Registration & Networking
  • 4:30 - 5:30 pm - Educational Presentation
  • 5:30 - 6:00 pm - Q&A
Registration Cost: Free and open for all to attend.

Program Description: Before viewing this replay, we recommend you watch and listen to the free recorded ICH GCP E6 (R2) Overview.

Recently, a long awaited new revision of the ICH E6 GCP Guideline was released as a response to the increase in scale, complexity, and cost of clinical trials. This new revision focuses on updating and clarifying standards for electronic records and essential documents, and investigator and sponsor oversight. As a result, new questions arise about how to best manage the operations and strategy of a trial to ensure that human subject protections are supported, data quality and integrity is maintained, and documentation is properly managed. This session will give you an action plan for how the new guidances affect your trials.

Upon completion of this Webinar, attendees should be able to:
  • Review the updates to the ICH E6 GCP Guideline
  • Identify how the finalized ICH guideline affects running clinical trials
  • Identify how the finalized ICH guideline affects sponsor oversight of the clinical trial
Contact hours:1.0 Contact hours (ACRP, CBRN, ACCME) are available 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 then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.

Contact Hour Cost:
  • $0 Chapter Members
  • $15 ACRP Members
  • $30 Non-Members
Refund Policy: Refunds will only be processed if the event is cancelled by the chapter.

Level: All audiences

Location

Rachel Upjohn Building
4250 Plymouth Rd.
Garden Level Floor Auditorium
Ann Arbor, MI 48109