Signature Series Session

ICH E6 changes are upon us. Are you ready to implement new expectations for Good Clinical Practice (GCP) and a flexible framework for clinical trial design and conduct? Please join us for a panel discussion on the principles described within ICH E6(R3), the changes from ICH E6(R2), the implications for GCP, considerations for implementation, and insights on how we as an industry can think through flexible design in a quality-minded environment. This is a session you will not want to miss. 

CEU: 1.00 ACRP

Speaker:

• Kassa Ayalew, MD, MPH, Director, Division of Clinical Compliance Evaluation, Office of Scientific Investigation, Center for Drug Evaluation and Research (CDER), U.S. Food & Drug Administration (FDA)

• Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, The Ohio State University

• Katherine Mary Marangio, Learning Program Consultant, Parexel

• Leslie Sam, BA, CSSBB, CQIA, President, Leslie Sam and Associates, LLC

Watch the Webinar Replay Ahead of the Live Session (Free Without Contact Hours):

• Crack the Code: A Comparison of ICH E6(R2) and ICH E6(R3)

Related Blog Content:

• The Impact of ICH E6(R3) on GCP: Implementing New Expectations in a Culture of Quality

Related Resource:

The new ACRP Guidelines and Regulations Resource Center has the most relevant and up-to-date resources for all professionals whose roles involve conducting and leading clinical research. ACRP will post updates and links to content impacted by the changes to the ICH E6(R3) Good Clinical Practice Guidelines.