In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers 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.
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.
Dave Kern has 25+ years in the life sciences and medical device industries, holding positions in Product Development, Program Management, Alliance Management, and most recently, Regulatory Affairs. Before starting K2 Regulatory Consulting, he was Head of Regulatory Affairs and Clinical Affairs at Illumina, where he built a global organization, with offices in China, Australia, and the UK. He also led the regulatory efforts to bring Illumina their first PMA product approval (Extended RAS Panel Test) in 2017.