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

Thursday, July 20, 2017, 2:00 PM - 3:00 PM ET

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

Click here to view event flyer.

Registration Cost:
  • $0 for Canadian Chapter members
  • $25 all others
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
Speaker: Sandra “SAM” Sather is an industry-leading consultant whose mission is to promote clinical quality systems for Sponsors/CROs and Investigators/Research Institutions. She has over 25 years of clinical experience, with a Bachelor of Science in Nursing and a Master of Science in Education with a Specialization in Training and Performance Improvement.

Contact hours: 1.0 Contact hour (ACRP, CBRN, ACCME) has been approved 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 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
Please click here to purchase contact hours. 

Refund Policy:
No returns of transfers.

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

Target Audience: Anyone involved in Clinical Research

Further Information: To register, please visit the Chapter Events section at www.acrpnet.org/canada. If you have any questions or require additional information, please contact us at canadianchapter@acrpnet.org.

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