Update to ICH GCP E6 (R2) – Final Changes and Implementation

Date: February 15, 2017
Time: 1:00pm-2:30pm, EST US
Duration: 90 Minutes
Price: $299 - Includes Bonus Handouts!

NOTE: Changes are now FINAL!  Join us to see what you need to know!

Course Description:

Recently, a long awaited new revision of the ICH E6 Guidelines 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.  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.

This 90-minute course will give you practical answers to frequently-asked best practice questions regarding the new responsibilities outlined in ICH 6 for sponsors, investigators/sites and monitors.  These questions include:

  • How do the new definitions for monitoring plan, certified copy, validation of computerized systems and the expansion on the definition of monitoring report affect me?
  • What responsibilities have changed in order to ensure data management integrity? 
  • What does the implementation of a study-level quality management system mean for your role? 
  • What new SOPs and processes should be in place for the validation and management of electronic systems? 

By attending this interactive live session, you will be able to:  

  • Apply critical thinking techniques for effective implementation of the new ICH E6 guidelines
  • Learn how the new guidances affect your role
  • Discuss challenges and opportunities in implementing the new guidances

This course will be of benefit to anyone responsible for complying with the GCPs, investigator, site personnel, sponsor/CRO and IRB/IECs.

Sam Sather Clinical Quality Systems Training Instructor

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. SAM is the vice-president of Clinical Pathways, a consulting firm located in the Research Triangle Park area in North Carolina, USA. SAM is dual certified by the Association for Clinical Research Professionals (ACRP) for over 10 years (CCRA and CCRC) and a current member of the ACRP Academy Board of Trustees and Regulatory Affairs Committee (RAC).  She is a frequent speaker for industry conferences and has authored dozens of courses for clinical research in various functional areas (e.g., monitoring, safety, HIPAA, and vendor management).