FDA Submissions Strategy
March 09 – 10, 2016, Sunnyvale, CA
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).
Agenda Topics Include
- Designing Submission Strategies aligned with Business Strategies
- Identifying areas of risk in the Submission Strategy
- Use of FDA’s Pre-Submission program to obtain critical feedback and reduce risk to the submission
- Developing successful materials for use during meetings
- Preparing the team for effective interactions
- Anticipating questions/objections
- Effective interactions with FDA during the review
- Preparing for and answering questions about your submission
This workshop will be beneficial to both novice and experienced medical device professionals involved in medical device submissions to the FDA. This program is particularly applicable to individuals in the following functions:
- Regulatory Affairs
- Clinical Affairs
- Research and Development
- Quality Assurance
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
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.
Hotel & Meeting Logistics
Time: Wednesday, 8:30 am - Thursday, 12:00 pm; Breakfasts (2), lunch (1) and reception included.
Location: Intuitive Surgical
1020 Kifer Rd.
Sunnyvale, CA 94086
Training Room 4 (Bldg 108)
Hyatt Regency Santa Clara
5101 Great America Parkway
Santa Clara, California, USA, 95054
Distance from workshop: 3.7 miles
Santa Clara Marriott
2700 Mission College Boulevard Santa Clara California 95054 USA
Distance from workshop: 3.5 miles
Embassy Suites by Hilton Santa Clara Silicon Valley
2885 Lakeside Drive, Santa Clara, California, 95054, USA
Distance to workshop: 2.1
Register for Technical Writing for Regulatory Submissions and FDA Submissions Strategy Workshops and receive a savings of $300 ($150 per workshop). Email firstname.lastname@example.org for the discount code.
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