September 30, 2014
11:00 am to 12 pm EDT

Sponsored by

Webinar Description:

This webinar will discuss the definition ofcurrent Good Clinical Practice (GCP)and the associated general concepts for in vitro diagnostic assays (IVDs). The Precision Team will discuss how to incorporate and implement these concepts into IVD clinical trials by supplementing with case studies utilizingthe correct techniques to employ GCP. The workshop will emphasize the appropriate clinical and quality processes that clinical site personnel can and should utilize while conducting IVD clinical trials to ensure compliance with regulatory requirements.

Learning Objectives:

• Understanding the applicable regulations when conducting an IVD clinical trial.
• Understanding the responsibilities of the different parties involved in an IVD clinical trial.
• Using monitoring & GCP to ensure protocol compliance and the quality of clinical data.
• Unique aspects of GCP in IVD clinical trials.

Speakers:

Charles G. Thornton, M.B.A., Ph.D.

Director, In Vitro Diagnostics ∓ Quality
Precision for Medicine

Dr. Thornton has over 25 years of industry and FDA experience, including extensive experience in in vitro diagnostics. He has designed and implemented Laboratory Developed Tests (LTDs) for the clinical laboratory, developed Good Clinical Practice quality systems for manufacturers, and designed, implemented, and managed clinical trials to generate data for regulatory submissions. Dr. Thornton previously served as a Scientific Reviewer within FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), and as a Reviewer within FDA’s Office of Compliance (OC), Division of Bioresearch Monitoring (BIMO).

Dr. Thornton received a BS in Biochemistry from the State University of New York at Stony Brook, an MBA from George Washington University, and a PhD in Biochemistry and Molecular Biology from Case Western Reserve University.

Judi Smith, M.S., MT(ASCP)

Vice President, In Vitro Diagnostics and Quality
Translational and Regulatory Sciences
Precision for Medicine

Ms. Smith has worked in the medical products regulatory, quality, and clinical trial areas for over 30 years. In that time, she has been responsible for the regulatory submissions and approvals of a multitude of companion diagnostic assays, in vitro diagnostic products, and biological in vitro diagnostic assays, and for the establishment of quality systems for diagnostic products. She has also developed and implemented clinical trials for these products that were used to generate data for the regulatory submissions. She also is on the faculty of the Regulatory Affairs Professionals Society (RAPS) University as an in vitro diagnostic Subject Matter Expert. As a member of the FDA/Industry Roundtable, Ms. Smith was awarded the FDA Group Recognition Award. She has served as President of the Association of Medical Diagnostics Manufacturers (AMDM) since 2006. This organization is dedicated to the in vitro diagnostic industry and provides educational programs with FDA’s Center for Devices and Radiological Health’s (CDRH) Office of In Vitro Diagnostics and Radiological Health (OIR). Ms. Smith also serves on the Board of the Regulatory Affairs Professional Society.

Ms. Smith received her BS from Temple University and her MS from Medical College of Pennsylvania.

Cost: No cost!