Pursuing Accelerated Approval in Oncology Indications: Is your Asset the Right Candidate?

MessageThis Webinar is over
Date Jun 16, 2016
Time 11 am EDT
Cost Free
Online
In this webinar we review a number of the benefits and considerations related to pursuing accelerated approval, offer advice on how to access the applicable expedited program, effectively interact with the Agency, follow the regulatory pathway most expeditiously, and highlight examples that illustrate both the advantages and challenges of pursuing Accelerated Approval.
Learning Objectives:
  • Understand expedited development/review options in the U.S. and EU
  • Identify potential benefits and risks of pursuing accelerated approval in oncology indications
  • Learn about the planning process for pursuing accelerated approval
  • Learn about how to execute trials designed for the accelerated approval pathway

 


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