How Does the Recent ICH-GCP E6 Update Affect YOU?-2017-06-15

Event Information
Event Name: 
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
Event Details
Event Type: 
Event Details: 

South Bay Educational Event
Thursday, June 15th, 2017
6:00 PM to 8:45 PM

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

Sandra “SAM” Sather, MS, BSN, CCRA, CCRC
VP of Clinical Pathways, LLC

1315 Chesapeake Terrace (Bldg. 5)
Sunnyvale, CA 94089
Free parking near building entrance
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

Join us for a stimulating presentation that analyzes the new guideline.

Learning Objectives:
1. Review the final updates to the ICH E6 (R2) GCP Guideline
2. Identify how the finalized ICH Guideline affects running clinical trials
3. 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. 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).

6:00 – 6:45 PM Registration, Networking, & Dinner Buffet
6:45 – 7:15 PM President’s Welcome, Volunteer and Sponsor Appreciation
7:15 – 8:15 PM Educational Presentation
8:15 – 8.45 PM Raffle, Open Mic, Networking 1:1 with speaker

Target Audience:
• Clinical Research Professionals
• Sponsors, Study Sites, Physicians, Nurses
• Vendors/Service Providers/CROs, Consultants
• Institutional Review Boards
• Related–Clinical Quality Assurance, Project Management, Account Rep, HR, Recruiters/Staffing, Finance, Biometrics, Regulatory and Students

EVENT REGISTRATION is now closed. Thank you for your interest.