Partnerships Asia Pacific Session Spotlight: Build Strong QC and QA Processes within Your Strategic Collaborations

Each week leading up to Partnerships in Clinical Trials Asia Pacific, we'll be highlighting a session from the upcoming conference. It will take place October 5-7, 2010, in Singapore. For more information, visit our webpage to download the brochure.

Featured Session: Build Strong QC and QA Processes within Your Strategic Collaborations to Ensure an Effective and Compliant Regional Sourcing Strategy
Speaker: Ying Tang, MD, President of Asia Pacific Operations, RPS, INC, China

About the session:
As biopharmaceutical companies develop various sourcing strategy to support the Asia-Pac region, it is clear that there is an increasing level of scrutiny by regulatory agencies on sponsors, providers and investigative sites regarding obligations to ensure adequate oversight and compliance of clinical trials. Regardless of the outsourcing model utilized, the Sponsor retains the ultimate obligation to ensure effective oversight of all internal and external activities related to the conduct of their clinical trial programs. Without an effective quality management process, the potential for good clinical practice (GCP) breaches that impact new drug approvals will continue to exist. This session will examine both a full-service and integrated (embedded) sourcing partnership.

The panel will address the following key elements:
• The key drivers of increasing regulatory oversight and scrutiny in Asia-Pac
• Application of Various QC and QA processes in different outsourced operating models ranging from integrated to full-service models
• Risk management strategies and degrees of sponsor oversight ranging from direct oversight to limited transfer of obligations to full transfer of obligations
• Interdependencies between Training, QC and QA processes
• Continuous improvement methodologies including application of quality KPIs,
error detection and prevention strategies, and audit preparedness and performance strategies