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Research and Markets: Navigating Through the Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach From Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada: September 18-19th, 2014 - Boston, MA

Research and Markets ( has announced the addition of the "Navigating Through the Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach From Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada: 2-day In-Person Seminar" conference to their offering.

In-vitro Diagnostics (IVD) products provide critical information on patients' health conditions, based on which healthcare provider develops and administers the treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.

This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.

Learning Objectives:

  • Understand why IVD is regulated differently.
  • An overview of IVD Regulations - U.S. FDA., Europe (MDD), Canada.
  • Develop Regulatory Strategies and determine Regulatory Pathways.
  • Inclusion and exclusion of data and information for different submission.
  • Format and Content of premarket submissions.
  • Product Label and Labeling for IVDs.
  • Working and interacting with the reviewers and regulators.
  • Tips and Suggestions to secure rapid regulatory approvals.

Who will benefit:

  • Department Managers (middle management)
  • Research & Development (R&D)
  • Product Design & Development
  • Validation Engineering
  • Regulatory Affairs
  • Quality Assurance
  • Quality Control
  • Manufacturing/Production

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