The Inside Track to Orphan Drug Designation - Webinar CD/Transcript

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The Inside Track to Orphan Drug Designation

Does the ODD process have you confused?

It has certainly confused many drug manufacturers. Only 480 out of 566 applications received orphan drug designation last year.

What can you do to not become a member of the group of “86”? Who is the logical person to go to?

A bit of insider knowledge might come in handy.

And who has better insider experience than the man who actually administered the Orphan Drug Act? Dr. Timothy Coté — former Director of the FDA Office of Orphan Products Development (OOPD) — will explain the ins and outs of obtaining orphan drug status.

During this session you’ll learn:

  • The differences in obtaining approval for orphan vs. non-orphan drugs
  • Detail prevalent criteria for orphan drugs
  • The clinical superiority in orphan drug designation
  • What is a “typical orphan drug”

Order today and learn how to obtain orphan drug designation from an industry insider.

  • Regulatory Affairs
  • Quality Assurance
  • Medical Director
  • Submission and applications specialist
  • Strategic planning and lifecycle management specialists
  • Executive management
  • General/corporate counsel
  • Regulatory professionals
  • Consultants/service providers

Dr. Timothy R. Coté, Principal & Chief Executive Officer, Coté Orphan
Dr. Coté is a leading national regulatory expert in orphan drug development. With 23 years of Federal experience at the FDA, NIH, and CDC, Dr. Coté recently served as the Director of the FDA Office of Orphan Products Development (OOPD) from Sept. 2007 – May 2011. In this role he had responsibility for administering the Orphan Drug Act and personally signed decisions on 1400+ orphan drug designation applications.