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During this interactive workshop, FDA and industry experts will lead you through the regulatory and practical guidelines governing 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 BIMO inspections
- Details about the regulatory requirements needed during trial conduct
- And more!
Hotel Block Information
Courtyard Irvine Spectrum | 7955 Irvine Center Drive | Irvine, CA 92618
Room rate: $189.00
Cut-off Date for reservations: Monday, April 22, 2019.
Book your group rate for Advamed Submissions Workshop