Innovation Seminar: Breaking Through the Barriers of the FDA
December 4 @ 11:30 am - 1:30 pm
If you are an innovator, researcher, or other professional staring down the FDA approval process, you know how intimidating it can seem! But with the correct knowledge, data, and strategy, you will find how manageable it truly is. Join Albany Medical College’s Biomedical Acceleration and Commercialization Center (BACC) and the UAlbany Innovation Center, both Innovate 518 Affiliated Partners, for a seminar on navigating the medical device regulatory process. Tony Blank, a national speaker on Regulatory Affairs and the FDA will give an overview of the medical device regulatory process. Tony will address quality systems and regulatory oversight, covering topics from trying to determine what class of product you have all the way through what to do after you have obtained FDA approval.
Tony Blank is President of Infinity Biomedical, a small regulatory consulting firm specializing in providing strategic and tactical regulatory support for medical devices and combination products. With over 30 years’ experience in the medical products industry, including 12 years at Boston Scientific Corp, Tony is a seasoned and respected regulatory affairs professional. Since forming Infinity Biomedical, he has been actively engaged with a variety of medical device companies providing crucial support ranging from early phase strategic regulatory planning to post-market compliance to a wide variety of medical device companies in the cardiovascular, ophthalmic, orthopedic, radiology, and oncology fields. Current and former clients include: Alcon Laboratories, Spectranetics, Royal Philips, Sirtex Medical, Becton Dickinson, PQ Bypass, Alcresta, Tusker Medical, CSA Medical, and Haemonetics.
11:30 a.m. to 12:30 p.m. – Registration, Networking, & Lunch
12:30 to 1:30 p.m. – Program