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product
FDA PMA Process for IVD Companies
This product was added to our catalog on Monday 02 February, 2009.
Item #:
Price:  $395.00
  
Product description
60 Minute Webinar Recording

Speakers
Sally Hojvat, PhD
Kathleen Simon, PhD
Zivana Tezak, PhD
FDA/Center for Devices and Radiological Health/Office of In Vitro Diagnostics/DMD


Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Ensuring a firm understanding of the regulatory pathways for new IVD products is critical in an atmosphere of increased market competition and need for early market release. The PMA process is costly, time-consuming, and complex and can put a strain on the resources of an IVD company. This audio conference will discuss the PMA process from an FDA perspective.
  • When is a PMA necessary?
  • Comparison of the PMA and 510(k) processes
  • How to avoid the potential pitfalls of the PMA process
  • About the Speakers

    Dr. Hojvat currently holds the position of Director of the Division of Microbiology Devices, in the Office of In - vitro Diagnostic Device (IVD) Evaluation and Safety, at the Food and Drug Administration (FDA). Prior to joining the FDA in 2003, Dr. Hojvat’s experience included 18 years in the IVD industry, holding positions in product development and support, quality control, scientific affairs and clinical research. Dr. Hojvat received a B.Sc. from the University of Wales, UK, a M.Sc. in Microbiology from the University of Alberta, Canada, and a Ph.D. in Biochemistry from Loyola University Medical School, Chicago. She also completed post doctoral training fellowships in Clinical Chemistry from Loyola Medical School and Pharmacology from the University of Chicago. Her research publications and presentations are concentrated in the fields of Clinical Microbiology, Pharmacology, Neuroendocrinology, Clinical Research, Emerging Infectious Diseases, Bioterrorism and the Regulation of in-vitro diagnostic devices.

    Dr. Tezak is currently a scientific reviewer in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety, Division of Microbiology Devices, at the Food and Drug Administration (FDA). Prior to joining the FDA in 2004, Dr. Tezak’s experience included positions with biotechnology industry as a research and development scientist with Gene Logic, Inc. of Gaithersburg, MD, followed by work with an array developer start-up company, Metrigenix, Inc. Dr. Tezak holds a B.Sc. in Chemistry and a M.Sc. in Biochemistry from University of Zagreb, Croatia, and a Ph.D. in Molecular Biology from Florida State University. She completed postdoctoral fellowships at the University of Pittsburgh Medical Center and Children's National Medical Center, Research Center for Genetic Medicine, on research projects in human genetics and gene therapy, working with emerging genomic high-throughput screening technologies and participating in setting up one of the earliest large academic microarray facilities. Her work resulted in a number of publications in peer-review journals, book chapters and proceedings.

    Dr. Simon is currently a Scientific Reviewer in the Division of Microbiology Devices, in the Office of In-vitro Diagnostic Device (IVD) Evaluation and Safety, at the Food and Drug Administration (FDA). Prior to joining the FDA in 2003, Dr. Simon worked in industry for an FDA regulated IVD company and then for a microarray manufacturer, holding positions in product research, development and support. Dr. Simon holds a B.Sc. in Biology from the University of New Hampshire and a Ph.D. in Microbiology from the University of Virginia. Her academic research interests were focused on cell adhesion signaling and viral oncogenes. Her research publications and presentations are concentrated in the fields of Molecular Microbiology, Cell Biology, Oncology and the Regulation of in-vitro diagnostic devices.

Cost
The cost to purchase the video recording is $395.

Once your order is processed you will shipped a copy of the video file on flash drive. The video comes in windows media format and can easily be played on your computer.
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