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MMA Roadshow: Managing App Development Under FDA Regulation
January 27, 2014
FDA recently published its final guidance on mobile medical apps, and while helpful, the guidance leads to more questions. This workshop will focus on answering those questions for app developers in or close to FDA regulated territory. Over the course of four hours, we will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space, to help both the novice and experienced FDA regulatory professional alike.
PROGRAM
8:00am: Welcome & Introduction
8:10 am: Session I
FDA Policy: Purpose of Guidance Document
Scope of FDA Regulation: Analyzing the New Guidance
Regulatory Quality & Leadership: Case Study Based Panel Discussion
10:30 am: Break
10:45 am: Session II
European Union Regulatory Update: Mobile Apps and Strategies for Regulatory Compliance
Brining Apps to Market in New Regulatory Contect: Panel Discussion
Q&A with a representative from the U.S. Food and Drug Administration
12:30 pm: Adjourn
Location:
Liebow Auditorium 2nd Floor of the Biomedical Sciences Building
San Diego, CA
Contact for Event
Janny Li
Phone: 858-822-1142
Email: vonliebigcenter@eng.ucsd.edu