How Will Risk-adapted Clinical Trials Be Inspected?

Track:
Innovative Approaches to Ensuring Compliance with Good Clinical Practice (GCP) and Quality Assurance (QA)

Day & Time:
June 26, 8:00AM - 9:30AM

Session Number:
314

Room Number:
156AB

Level:
Intermediate

Type:
Session

Title:
How Will Risk-adapted Clinical Trials Be Inspected?

Chair(s):
John Poland, PhD
Senior Director, Regulatory Policy and Compliance
Covance Clinical Development Services, United Kingdom

Description:
The particular challenges posed by GCP inspection of a risk-adapted clinical trial, and how they may be addressed, will be analyzed and discussed in terms of regulatory agency expectations and practical examples.

Learning Objective(s):
Discuss the particular challenges associated with GCP inspection of a risk-adapted clinical trial; Describe how these challenges may be addressed.

Presentation(s) & Speaker(s):
FDA Point of View
Ann Meeker-O'Connell, MS
Director, Division of GCP Compliance (Acting), OSI, Office of Compliance, CDER
FDA, United States

EMA Point of View
Fergus Sweeney, PhD
Head of Sector, Compliance and Inspection
European Medicines Agency, European Union, United Kingdom

Industry Point of View
Mike Sobczyk, MSc
Senior Director, Regulatory Compliance
Gilead Sciences, Inc., United States