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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.

Learning Objectives:

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.
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Who will benefit:

This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions:

  • 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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Day 01(8:30 AM - 4:30 PM)
  • Registration Process: 8:30 AM – 9:00 AM
  • Session Start Time: 9:00 AM
  • UNITED STATES
  • Session 1: 09:00 AM – 10:30 AM
    • Evolving technologies and challenges of In-vitro Diagnostics (IVD) products
    • Why the regulators need separate regulations even IVD is considered a device?
    • Know the process and players at OIR (aka OIVD) of CDRH and Health Canada
  • Morning Break: 10:30 AM – 10:45 AM
  • Session 2: 10:45 AM – 12:15 PM
    • Overview of US-FDA Regulations for IVDs
  • Lunch Break: 12:15 PM – 1:15 PM
  • Session 3: 1:15 PM – 2:45 PM
    • Determination of classification & Identification of Predicate Device(s)
    • Development of Regulatory Strategies and Pathways for IVDs
    • Special consideration of IVD labeling requirements
  • Afternoon Break: 02:45 PM – 03:00 PM
  • Session 4: 03:00 PM – 04:30 PM
    • Determine the type of the required pre-market submission for your IVD
    • Format and Content of 510(k), Pre-IDE, IDE and PMA
    • What is a Clinical Laboratory Improvement Amendment (CLIA) of 1988?
    • Preparation and submission for CLIA Waiver Application
Day 02(8:30 AM - 4:30 PM)
  • EUROPE
  • Session 5: 09:00 AM – 10:30 AM
    • Overview of European IVD Regulations
    • Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents
  • Morning Break: 10:30 AM – 10:45 AM
  • Session 6: 10:45 AM – 12:15 PM
    • Special consideration to Classification Rules for IVDs
    • Conformity Assessment for CE Marking
    • Special Labeling and electronic Labeling Requirements for IVDs
    • Preparation of Technical File or Design Dossier
  • Lunch Break: 12:15 PM – 1:15 PM
  • CANADA
  • Session 7: 1:15 PM – 2:45 PM
    • Overview of Canadian Medical Device Regulations (CMDR) for IVDs
    • Understanding similarities and differences between U.S. and Europe regulations
  • Afternoon Break: 02:45 PM – 03:00 PM
  • Session 8: 03:00 PM – 04:30 PM
    • Format and Content of Canadian Medical Device License (MDL) Application
    • Inclusion of the required data and information for MDL application
    • Conclusion & Summary of the course
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David Kern

David Kern
Owner, K2 Regulatory Consulting

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.

Dave joined Illumina in 2014 as part of the acquisition of the consulting firm Myraqa. While at Myraqa he worked for five and a half years as a regulatory consultant, collaborating with clients on a variety of projects in the areas of infectious disease, oncology, cognitive disorders and companion diagnostics.

Prior to that, Dave was Director of Program Management at both Adamas Pharmaceuticals and CareDx. He also worked for seven years at Affymetrix, first in Program Management and later in Strategic Alliances. Previous to that he worked at for seven and a half years Chiron Diagnostics, where he was part of the product development team that launched one of the first HIV viral load tests, using Chiron’s bDNA technology.

Dave has a B.S degree in Biochemistry from San Francisco State University, and an MBA from San José State University. He also holds an RAC from the Regulatory Affairs Professional Society (RAPS).

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