How Does the Recent ICH-GCP E6 Update Affect YOU?
Speaker: Sandra “SAM” Sather, MS, BSN, CCRA, CCRC, VP of Clinical Pathways, LLC
Program Description: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:
- Review the final updates to the ICH E6 (R2) 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
Registration Fees:
- $5 - Chapter Member
- $30 - ACRP Member
- $30 - Non-Member
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).
Agenda:
- 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 Student
ENTER TO WIN A $50 VISA Gift Card!
Test your knowledge on how the recent ICH-GCP E6 Update affects you. Click the link (below) and complete the survey by Thursday, June 8.
Of those who complete the survey, one will be randomly selected to receive a $50 Visa gift card. You must be present at the event to win.
http://www.surveygizmo.com/s3/3567884/How-Does-the-Recent-ICH-GCP-E6-Update-Affect-YOUThis event has been approved for 1.0 contact hours.
Please click here to purchase contact hours.
Contact hours must be purchased separately and not included in registration.
v05.16.2017