Greater Cincinnati: How Does the Recent ICH-GCP E6 Update Affect You?

Thursday, May 25, 2017, 5:30 PM - 8:15 PM (UTC-5:00) Eastern Time (US & Canada)

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

Speaker: Sandra "SAM" Sather

Program Agenda:
  • 5:30 –6:00 pm – Registration & Networking
  • 6:00 - 6:45 pm – Chapter Meeting/UC Presentation
  • 6:45 – 8:00 pm – Educational Presentation (Webinar)
  • 8:00 – 8:15 pm – Q&A/Discussion
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 guidance affects 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
Target Audience: Anyone involved in Clinical Research

Registration Cost: $0 (Free) Chapter Members / $15 ACRP Members/ $30 Non-Members

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: All cancellation requests must be made in writing and received at least 15 calendar days prior to the day of the course. Cancellation requests received after this time will not be refunded.

Level: Intermediate-Level (2-5 years of experience)

Further Information: For questions, Contact the Chapter through email at greatercincinnatiacrp@gmail.com.

Location

University of Cincinnati
Walters Hall, Room 100
955 Plainfield Road
Blue Ash, OH 45236

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