SOLD OUT-REGISTRATION IS CLOSED-Special 2nd Evening Event with ACRP--How Does the Recent ICH-GCP E6 Update Affect YOU?-Sandra “SAM” Sather, MS, BSN, CCRA, CCRC-06/15/2017 - 6:00pm

Event Information
Event Topic: 
SOLD OUT-REGISTRATION IS CLOSED-Special 2nd Evening Event with ACRP--How Does the Recent ICH-GCP E6 Update Affect YOU?
Event Date: 
06/15/2017 - 6:00pm
Event Location: 
Cepheid 1315 Chesapeake Terrace (Bldg. 5) Sunnyvale, CA 94089
Speaker Information
Event Speaker: 
Sandra “SAM” Sather, MS, BSN, CCRA, CCRC
Event Speaker Title: 
VP
Event Speaker Company: 
Clinical Pathways, LLC
Event Speaker Bio: 

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).

Event Details
Cost: 
N/A - EVENT CLOSED
Event Details: 

Discussion of the guideline updates, impact assessment, and a scalable approach to implementation.
Purpose of ICH-GCP E6:
• Provides unified standard for: European Union, Japan, United States, Canada, and Switzerland
• Facilitate mutual acceptance by the regulatory authorities of data from clinical trials.
ICH-GCP E6 is in response to:
• Increase in scale, complexity, and cost of clinical trials
• Global Audit Findings
Focus of ICH-GCP E6:
• Updating and clarifying standards for electronic records and essential documents
• Encourage sponsors to implement improved oversight and management of clinical trials
• Facilitate innovative approaches (QRM, QbD, technology) to clinical trials

The event above is now CLOSED.