IVD Product Development
April 19-20, 2013
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.
- Introduction to IVDs
- Drafting of a Package Insert
- Product Development Process
- Design Control
- Risk Analysis and Failure Mode and Effects Analysis (FMEA)
- Companion Diagnostics
- 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
- Q&A Panel Discussion
- 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!
Larry Mimms, Ph.D.
20+ years in IVD Product Development, Strategic Planning and Business Development; Abbott Labs, Gen-Probe, Quidel
Valerie Day, M.S., MBA
Abbott, Gen-Probe, Dexcom, Quidel
Damon Getman, Ph.D.
Hologic, R&D Product Development
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 CenterFriday & Saturday, 8:00AM - 5:00PM
A small price to pay to jumpstart your foray into molecular diagnostics.