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Regulatory Challenges Facing In-Vitro Diagnostic in U.S.-OnlineWebinar

Thursday, Apr 27, 2017 at 10:00AM - 1:00PM

Online Event

  • Apr 2017

    27 Thu

    10:00AM

  • Apr 2017

    27 Thu

    1:00PM

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Regulatory Challenges Facing In-Vitro Diagnostic in U.S.-OnlineWebinar

Thursday, Apr 27, 2017 at 10:00AM - 1:00PM

Fremont

No tickets available

Description
In-vitro diagnostic (IVD) products drive a significant portion of clinical decision making today. IVDs assist in the identification, diagnosis and monitoring of disease. They play an ever-expanding role in the selection of appropriate therapeutic interventions in healthcare delivery with the advent of personalized medicine. These key products are a distinct class of medical devices regulated in the US by the Food and Drug Administration (FDA).

Objectives Of The Presentation
  • Discuss the current state of IVD regulations in the US and other regions
  • Identify and explain areas of IVD regulations related to:
    • product classification
    • IVD development, testing and premarket submission
    • post market regulatory maintenance and responsibilities for IVD manufacturers
  • Identify potential future challenges facing IVD manufacturers
  • Discuss IVD technologies and emerging trends
  • Apply IVD-specific regulations and guidelines for successfully traversing regulatory hurdles
Why Should you Attend
This course provides an overview of in vitro diagnostic medical devices with a focus on FDA's regulatory requirements. It introduces key regulations and guidelines necessary for effective product development, explains what IVDs are and describes development and testing, getting a product to market, product review and FDA submission requirements.

Areas Covered
  • Introduction
  • Focused Oversight
  • Risk-Based, Phased-in Oversight
  • Evidence Standards
  • Third Party Review
  • Clinical Collaborative
  • Transparency
  • Modification
  • Quality System Requirement
  • Post market Surveillance
  • Conclusion
Who will Benefit
  • Clinical Laboratories
  • Cost Control Consultants for healthcare practice
  • Regulatory Affairs Managers for manufactures
  • Risk Managers for healthcare practices
  • Medical Device & Diagnostic Manufacturers
  • Practitioners using LDTs
  • Pathology practice groups
For Registration
http://onlinecompliancepanel.com/webinar/REGULATORY-CHALLENGES-VITRO-DIAGNOSTIC-US-508213/APRIL-2017-ES-EZEVENT


Note: Use Promo code DE5YU and get 10% off on registration (Valid till APRIL 30th 2017)

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