FDA Regulation of In Vitro Diagnostics

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Category FDA Regulation; Clinical affairs, Regulatory compliance training

Deadline: November 19, 2014 | Date: November 20, 2014

Venue/Country: Web Based-Seminar, U.S.A

Updated: 2014-10-29 15:28:30 (GMT+9)

Call For Papers - CFP

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.

Areas Covered in the Session:

Definition of IVD

FDA Regulatory Pathways

QSR/CLIA Compliance

Product Labeling

Who Will Benefit:

CEOs

VPs

Compliance officers

Clinical affairs

Regulatory affairs

Quality assurance

R&D

CROs

Consultants

Contractors/subcontractors

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.