IVD Product Development

April 19-20, 2013

UCSD Extention

As San Diego's biotech and In Vitro Diagnostics (IVD) companies mature, the need for professionals with a broad understanding of the multiple skills required to be effective in a biological product development environment blending biological development with hardware and software innovations will increase. The course will focus on issues in moving an IVD product from concept to regulatory approval and market launch. Although the focus is on IVD product development, much of the material is applicable to product development in other areas of biotechnology and pharmaceuticals.

Agenda

Day 1

  • Introduction to IVDs
  • Drafting of a Package Insert
  • Product Development Process
  • Design Control
  • Risk Analysis and Failure Mode and Effects Analysis (FMEA)
  • Companion Diagnostics

Day 2

  • Principles of Assay Development
  • Instrumentation and Software for IVDs
  • Preclinical and Clinical Trial design
  • Case Study 1: Blood Screening and Intrapreneuring
  • Case Study 2: Cancer
  • IVD Regulatory Issues
  • Exam
  • Q&A Panel Discussion



Course Goals

  • Understand the IVD product development process beginning to end
  • Learn the "language" of IVD
  • Think like an IVD product developer

Learn IVD with the best in the business!

Instructors

In Vitro Diagnostics Product Development UCSD Extension Course

Friday, April 19th 2013 at 8am to Saturday, April 20th 2013 at 5pm

6256 Greenwich Dr

San Diego, CA

University City Center

Friday & Saturday, 8:00AM - 5:00PM

Who Should Attend?

This course provides managers, entrepreneurs, investors, and scientists an overview of regulatory, clinical, scientific, and business aspects of In Vitro Diagnostics product development.

Fee: $495

A small price to pay to jumpstart your foray into molecular diagnostics.