Partnerships Asia Pacific Session Spotlight: FDA Updates: Ensuring Quality & Compliance in Your Study to Streamline Clinical Development in Asia

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: FDA Updates: Ensuring Quality & Compliance in Your Study to Streamline Clinical Development in Asia
Presenter: Byungja Marciante, Investigator / Assistant Director, US-FDA SHANGHAI OFFICE, China

Currently, almost every major US pharmas are running clinical trials in Asia. This presents many new challenges and growing international work for the agency regarding safety and quality management. To address this, FDA launched the “Beyond Our Borders” initiative. This session will provide details and open the discussion on how to work with FDA to ensure GCP compliance while conducting studies in Asia.

• Understand FDA foreign country inspection procedures
• Gain insights into the GCP auditing process and learn how to prepare for FDA inspections
• Site selection criteria – avoid pitfalls in choosing qualified trial conducting sites
• Fulfill US FDA requirements on data quality and compliance to expedite the approvals process