January 21, 2015 | Register Today to Reserve Your Space!
The quality of a submission to FDA in support of marketing authorization (pre-submission, 510k, special 510k, PMA, or de novo)has a significant impact on the timeline to commercialization. This webinar will discuss in a point and counterpoint format the key issues on how to present information to FDA on the clinical trial, data analysis, and presentation of the data from two perspectives, representing different backgrounds, specifically an ex-FDA reviewer and IVD regulatory expert. Both experts have over 25 years’ experience with IVDs in industry, FDA, and/or consulting.
- Understanding the importance of organization, presentation, transparency, and accuracy.
- Describing analytical studies, clinical validation studies, and pivotal studies validating cutoffs.
- Presenting data and performance claims
- Communicating with FDA to resolve issues and concerns.
- Asking FDA questions to obtain the best possible response.
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!
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You may also be interested in registering for these other Precision for Medicine webinars:
September 30: Good Clinical Practices and Conducting Effective Clinical Trials for IVDs in the US
October 31: Detecting Fraud in IVD Clinical Trials
January 27: Bridging Studies for US IVDs and CDx