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Bridging Studies for US IVDs and CDx

March 10, 2015 | Register Today to Reserve Your Space! 

Sponsored by Precision for Medicine 

Webinar Description:

During IVD assays’ life cycle, they often undergo modifications during the performance validation process and more often in the post- marketing setting. This webinar will discuss two types of bridging studies: 1) The pre-launch performance validation bridging studies required by FDA for changes made to the IVD, and 2) The post-launch analytical validation of changes made to an IVD to optimize reagents or procedures.

Speakers:

Kennon Daniels, Ph.D.

Senior Consultant, In Vitro Diagnostics Regulatory Affairs
Translational and Regulatory Sciences
Precision for Medicine

Dr. Daniels has over 11 years of R&D and US Regulatory Affairs experience with in vitro diagnostic (IVD), medical device and pharmaceutical products. She has extensive expertise with IVDs and specializes in the development of regulatory strategies and submissions for a wide range of IVD assays (>30 products) including assays for oncology, genetic disorders, women’s health issues, cardiac biomarkers, infectious diseases, microbes, sepsis and diabetes. She is also responsible for the design of analytical and clinical protocols for the performance validation of these IVD assays to generate data for the regulatory submissions. Dr. Daniels is skilled in serving as the client representative during face to face meetings and teleconferences with FDA (CDER/CBER/CDRH/OIR).

Dr. Daniels received a BS in Biology from Mary Baldwin College and her Ph.D. in Human Genetics from Virginia Commonwealth 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 

February 24: FDA Perspective on IVD Clinical Trial Descriptions, Data Analyses, and Data Presentations in FDA Submissions 


For reprints and/or copyright permission, please contact  Terry Manning, 781.972.1349 , tmanning@healthtech.com.