戻る Agenda
Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball
Session Chair(s)
Kay Weiler, BSN, JD, MA, RN
Vice President
CompleWare Corporation, United States
Innovative methods to detect potential GCP noncompliance before, during and/or after clinical trial execution have been developed. This forum discussion will present approaches from FDA and a sponsor.
This forum has been developed by the Good Clinical Practices and Quality Assurance Community.
Learning Objective : Describe an overview on the use of analytical methods to detect and monitor GCP noncompliance; Discuss FDA risk-based signal detection methods used for inspection site selection.
Speaker(s)
FDA Point of View
Ann Meeker-O'Connell, MS
Novartis, United States
Executive Director, Monitoring Excellence Head
Sponsor Perspective
C. Grant Simmons, MSC
Novartis Pharmaceuticals Corporation, United States
Head, ClinOps Analytics and Systems, Global Operations Services, IDFR