Empowering professionals for over 24 years

Empowering professionals for over 24 years

Diagnostic Development Primer  | CPE

Diagnostic Development Primer  | CPE
  • Level: Beginner
  • CPE: 1.5 Credits
  • Time: 41 Minutes

Diagnostic Development Primer offers a comprehensive guide to IVD and LDT approval pathways, covering FDA regulations, Class I-III requirements, and QSR impact. Guidance on securing diagnostic reimbursement from Medicare, Medicaid, hospitals, and private payers to ensure commercialization success.

  1. Understand the diagnostic development process to make smarter investment, partnership, and commercialization decisions in a rapidly growing market
  2. Gain insight into regulatory requirements and market dynamics that shape diagnostic success
  3. Explore the critical role of companion diagnostics in personalized medicine and their impact on biopharma partnerships
  • Best Value: Unlimited Learning
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  • 1-month access to all course material
  • CPE credits included
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  • Self-paced and on-demand
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  • Overview
  • Agenda
  • Features
  • Justify This Training
  • FAQ

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Agenda

  1. Development and Regulation

    Summarizes the regulatory pathways for various types of diagnostics, comparing FDA and CMS oversight, and highlighting key differences between in vitro diagnostics and laboratory-developed tests.

  2. Diagnostic FDA Classification and Approval Pathways

    Explains diagnostic regulations by classifying risk for Class I-III devices and outlining FDA pathways such as 510(k), de novo 510(k), and PMA.

  3. Reimbursement

    Describes the methodology for economic evaluation and reimbursement of novel diagnostics.

Features

  • Closed Captioning in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Transcripts in English, Spanish, French, French Canadian, Hindi, Japanese, Korean, Mandarin, Russian, Standard Arabic
  • Course materials
  • Real-time tracking
  • Progress reporting
  • Accessibility features
  • Corporate account upgrades
  • LinkedIn certificate attachment
  • Verified certificates

Justify This Training

View our “Justify This Training” checklist and letter to craft a persuasive request that clearly shows the value of Biotech Primer training to your role and your company. This step-by-step guide helps you highlight ROI, align with business goals, and increase your chances of getting this course approved.

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