2020 - Navigating through Maze of In-vitro Diagnostics (IVD) Regulations: A systematic approach from Regulatory Strategy to Regulatory Approvals in U.S./Europe/Canada

After completion of this two day interactive course on IVD, the attendee will be able to:
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.