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.
This course has been pre-approved by RAPS as eligible for up to 6 credits towards a participant’s RAC recertification upon full completion.
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
- Anna Schroeder, Biomedical Engineer, IDE Program, CDRH, FDA
- Martin Hamilton, CDRH Office of Compliance, Division of Bioresearch Monitoring, U.S. Food & Drug Administration
- Peter Knauer, CMC/Regulatory Executive, Founding Partner, Sage BioPartners; Strategic Partner, Master Control
- Jennifer Henerson, Partner, FDA Medical Devices Regulatory Practice Group, Hogan Lovells LLP
- Todd Gross, 3D Communications
- Tony Blank, Cofounder & Senior Advisor, Barton & Blank LLC
- Additional speakers to be announced
AdvaMed Member Registration: $995.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $1,295.00
Cancellation and Refund Policy
All cancellations must be received via email to AdvaMedEvents@AdvaMed.org. Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 10 business days prior to the start of the program, including "no shows".
We welcome substitutions in lieu of cancellations at any time. Please contact us at AdvaMedEvents@AdvaMed.org with the substitute's registration information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.
Topics and speakers are subject to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee will be refunded or applied to the rescheduled program in accordance with the registrant's preference. In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.