Click here to go to the previous page
Using Risk-based Signal Detection Methods to Identify Sites with Potential GCP Problems: Better Than a Crystal Ball
Program Code:
224A
Date:
Tuesday, June 25, 2013
Time:
8:00 AM to 9:30 AM
EST
SPEAKER
(S):
Kay L. Weiler, BSN,JD,MA,RN (SCHNON), Vice President, Compleware, United States
C. Grant Simmons,
MSc (SPKNON), Director, Clinical Systems Innovation,
Novartis Pharmaceuticals Corporation, United States
Grant Simmons is currently the Global Head of Clinical QA Operations at Novartis. He has been a Biostatistician, a GCP auditor, Audit Manager and founder of the Clinical Systems Validation QA group within Clinical QA. Grant holds a BS in mathematics & a Master of Applied Statistics.
|
Ann Meeker-O'Connell,
MS (SPKAGY), Senior Director, QA Clinical Strategy Team Lead,
Janssen Pharmaceutica Inc., United States
Ms. Meeker-O’Connell joined CDER’s Office of Scientific Investigations in March 2010. Prior to FDA, Ann spent 10 years in clinical compliance roles in industry and academia. Ann is actively involved in initiatives to develop risk-based approaches to clinical trial design, conduct, and oversight.
|
Description
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.