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GCP Quality Agreements

Track:
Innovative Approaches to Ensuring Quality in Clinical Trials and Compliance to Good Clinical Practice

Day & Time:
June 19, 9:00AM - 10:30AM (Pacific Standard Time)

Session Number:
408

Room Number:
8

Level:
Intermediate

Type:
Session

Title:
GCP Quality Agreements

Chair(s):
Angelika Tillmann
Vice President Global Clinical Quality Assurance and Compliance
Theorem Clinical Research, Germany

Description:
This session will present and analyze the utilization of quality agreements in GCP from three different perspectives. These perspectives will include a CRO utilizing quality agreements with the CRO’s vendors,a CRO having quality agreements with the sponsors, and from a sponsor organization having quality agreements with their CROs. All presentations will critically analyze the effectiveness of strategies in the utilization of quality agreements for the mutual benefit of all parties involved and their impact on quality for the conduct of clinical trials.

Learning Objective(s):
Analyze the utilization of quality agreements in GCP to enable sponsor and CRO Quality Assurance staff to evaluate their impact and effectiveness.

Presentation(s) & Speaker(s):
Quality Agreements from the Sponsor Perspective
Barney Horne, RPh
Senior Director, Quality Assurance
Daiichi Sankyo UK Ltd., United Kingdom

Quality Agreements: Help or Hindrance?
Angelika Tillmann
Vice President Global Clinical Quality Assurance and Compliance
Theorem Clinical Research, Germany

Vendor Quality Agreements: Complement to Quality Compliance
Kimberly Washburn
Senior Director, Quality Assurance
Quintiles Transnational Corporation, United States