IDE Submissions Workshop - Spring 2019

Yarmela Pavlovic and Gerard Prud’homme were speakers at the IDE Submissions Workshop – Spring 2019. The workshop covered  the regulatory and practical guidelines when an investigational device exemption (IDE) is required.

Agenda topics include:

  • The purpose of an IDE.
  • Tips on making the best use of pre-submission meetings.
  • Components of a successful IDE submission.
  • Common errors and deficiencies in an IDE application.
  • The ins and outs of bioresearch monitoring program (BIMO) inspections.
  • Details about the regulatory requirements needed during trial conduct.


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