Sponsorships and Speaking Engagements | 15 May 2019 | Irvine, California, United States

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.