Presented to:

ACRP of Southern Wisconsin
Milwaukee, WI
November 21, 2008

North Central Regional Chapter of SoCRA
Minneapolis, MN
April 9, 2008

16th Annual SoCRA Conference, 
Denver, CO 
September 29, 2007

Copyright© - P. Below Consulting, Inc. 2008
All rights reserved.

Presentation:

• ACRP of Southern Wisconsin Presentation (11/2008): Where the FDA Regulations End and ICH GCP Begins - The Differences & Similarities Between the Two (PowerPoint, 815KB)
• Local SoCRA Presentation (04/2008): Where the FDA Regulations End and ICH GCP Begins - The Differences & Similarities Between the Two
  (PowerPoint, 806KB)
• National SoCRA Presentation (09/2007): Where the FDA Regulations End and ICH GCP Begins - The Differences & Similarities Between the Two
  (PowerPoint, 455KB)

References:

• FDA Draft Guidance: Supervisory Responsibilities of Investigators, May 2007 (link to FDA site)
• ICH E6 Good Clinical Practice: Consolidated Guidance (link to FDA site)
• FDA Information Sheet Guidances for Institutional Review Boards, Clinical Investigators, and Sponsors (link to FDA site)
• Comparisons of ICH GCP Guidelines with FDA Regulations - Informed Consent (from IRB Forum - link to their site)
• Comparisons of ICH GCP Guidelines with FDA Regulations - IRBs (from IRB Forum - link to their site)
• FDA Guidance for Industry: Acceptance of Foreign Clinical Studies (link to FDA website)
• ICH E2A Clinical Safety Data Management - Definitions and Standards for Expedited Reporting (link to ICH website)