Effective navigation of the FDA application process requires an approach that is both thoughtful and strategic. This workshop is designed to prepare you for the development and execution of effective submission strategies for your Investigation Device Exemptions (IDEs), Premarket Approvals (PMAs), Humanitarian Device Exemptions (HDEs), and Premarket Notifications (510(k)s).
This course has been pre-approved by RAPS as eligible for up to 10 credits towards a participant’s RAC recertification upon full completion.
- Connecting the regulatory and business strategies
- U.S. submissions strategy
- Using the pre-submission program to reduce risks
- Planning for pre-sub interactions
- Preparing for pre-sub meetings – the submission
- Preparing for pre-sub meetings – preparation
- Preparing and presenting effective presentations
- Effective meeting closure
- Meeting review
- Effective interactions with FDA during submission review
Tony Blank, Cofounder and Senior Advisor, Barton & Blank, LLC
Tony Blank is Cofounder and Senior Advisor at Barton & Blank LLC, a specialized regulatory consulting firm for the medical device and combination products industry. Mr. Blank has served in a variety of roles in the medical products industry - including Clinical and Regulatory - for the past 25 years. Most recently, Mr. Blank spent 12 years at Boston Scientific Corporation in both Corporate and Business regulatory leadership roles, including Vice President of Regulatory Affairs for the CRV businesses (Cardiology, Rhythm and Vascular). Under his leadership, the Boston Scientific obtained numerous regulatory approvals for medical devices and combination products. Among these are world wide regulatory approvals for drug-eluting stents, implantable cardioverter defibrillators (ICD) and cardiac resychronization therapy defibrillators (CRT-D), cardiac pacemakers and cardiac resynchronization therapy pacemakers (CRT-P), and detachable coils for peripheral embolization.
Mr. Blank has likewise been an active representative for Boston Scientific, the medical device industry and the regulatory profession on numerous policy issues working with AdvaMed. Among these activities has been participation in numerous Industry Working Groups – including the Pediatric Devices, Advertising and Promotion, and Reprocessing Working Groups (each of which he co-chaired). He is very involved in developing and delivering meaningful educational programs in the field of Regulatory Affairs and has been a regular speaker at educational events. In addition to his time at Boston Scientific, Mr. Blank has worked with Cardiopulmonary, Surgical, Ophthalmic, Vascular Access and Critical Care medical devices.
701 Pennsylvania Avenue, NW
Washington, DC 20004
AdvaMed Member Registration: $1,595.00
AdvaMed Accel Member Registration: $695.00
Non-Member Registration: $2,095.00
Government and Non-Profit Registration: $695.00
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.