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Embassy Suites Old Town Alexandria

Nov 05, 2013 7:00 AM - Nov 05, 2013 5:15 PM

1900 Diagonal Road, , Alexandria, VA 22314 , USA

DIA Meeting on Combination Products

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Use of Mobile Medical Applications as Companions

Session Chair(s)

Bradley Merrill Thompson

Bradley Merrill Thompson

General Counsel, Combination Products Coalition

Epstein, Becker and Green P.C., United States

FDA has predicted that it will come out with a final guidance on mobile medical apps by October 1. This session will explore that final guidance, teasing apart exactly what types of apps in the pharmaceutical space will be regulated and which ones will not. To make the session more dynamic, we will explore several pre-prepared case studies that focus squarely on the difficult issues associated with applying that guidance to the pharmaceutical use cases. Three commentators will provocatively discuss the different possible interpretations of the guidance as applied to the case studies, and then we will ask the audience, using an electronic polling system, to vote to put the technology at issue into one of the following four categories: a.) Unregulated mobile app; b.) FDA regulated drug labeling; c.) FDA regulated medical device; or d.) FDA regulated medical device constituent part of a combination product. After seeing the audience poll, the panel will discuss whether they agree with the audience’s assessment.

Speaker(s)

Bradley Merrill Thompson

FDA Regulation of Mobile Apps

Bradley Merrill Thompson

Epstein, Becker and Green P.C., United States

General Counsel, Combination Products Coalition

Case Studies and Audience Interaction

Mary Ann Smith, MS, RPh

Novartis Pharmaceuticals Corporation, United States

DRA Policy Head of Medical Device and Combination Products

Case Studies and Audience Interaction

Azin Shahzamani

Genentech, A Member of the Roche Group, United States

Senior Director, Regulatory Affairs

Case Studies and Audience Interaction

Jafar Shenasa

Proteus Digital Health, Inc., United States

Senior Director, Regulatory Affairs

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