The FDA’s New Device Pre-Submission Program


The FDA’s New Device
Pre-Submission Program:
What Does It Mean for You?

Your office, April 21, 2014


Meet your instructor

Albert Ghignone is the CEO of AAG Incorporated. A widely respected speaker on the topic, he's has more than 30 years’ experience providing insights to industry on regulatory affairs, quality assurance and clinical affairs. He has expertise dealing with all aspect of the FDA approval process for medical devices, drugs, biologics and generics.

He has also worked inside companies in every major segment of the industry, including research, quality assurance, regulatory affairs, manufacturing and clinical.