Introduction to FDA Regulation of In Vitro Diagnostics

You should attend this webinar to gain a fundamental understanding of FDA’s regulation of In Vitro Diagnostics.

Thomas E. Colonna
Thomas E. Colonna
Thursday, June 25, 2020
10:00 AM PDT | 01:00 PM EDT
60 Minutes

More Trainings by this Expert   Product Id : 503142

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$150 Live
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$390 Corporate Recorded
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In vitro diagnostic devices, or IVDs, are assays designed to test body fluids for the presence of any substance of interest to researchers, clinicians, and healthcare providers.

IVDs can be used to detect hormones or antibodies, viruses or expressed cancer genes, bacteria or bacterial resistance to antibiotics, and beyond. The Food and Drug Administration (FDA) has created a flexible, yet sometimes confusing, approach to IVD regulation.

In addition, FDA regulation and enforcement discretion relating to IVDs developed by clinical laboratories for internal use, key reagents required for developing such tests, instruments needed to analyze IVDs, and sample collection kits used to obtain specimens will be addressed.

Why should you Attend: To gain a fundamental understanding of FDA’s regulation of In Vitro Diagnostics.

Areas Covered in the Session:

  • Definition of IVD
  • FDA Regulatory Pathways
  • QSR/CLIA Compliance
  • Product Labeling

Who Will Benefit:
  • Regulatory Professionals Working in the field of in Vitro Diagnostics

Speaker Profile
Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia.

Dr. Colonna provides consulting services in the scientific and regulatory aspects of a wide range of medical devices and biologics with particular expertise in the areas of in vitro diagnostics (ELISA-based, PCR-based, SNPs, microarrays, and pharmacogenomics), medical device software (including bioinformatics), and biotechnology-based products.

Dr. Colonna's consulting clients range from Fortune 500 companies to small start-up companies located throughout the US, as well as, Canada, India, and Russia. Widely published in numerous fields, Dr. Colonna brings a unique multidisciplinary approach to problem solving.

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