Managing mHealth App Development Under FDA Regulation
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.
We have selected some of the world’s leading engineering universities – in the US and in the EU – to be our partners in this program. We have sought out not only the best schools, but those located in population centers near where developers are working.
We will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space.
Locations include:
- University of Illinois at Chicago
- Johns Hopkins University
- University of California San Diego
- Stanford University
- University of Texas at Austin
- Massachusetts Institute of Technology (MIT)
- mHealth Europe Summit (Berlin, Germany)
Agenda
Over the course of a four hour program, we will examine topics such as:
- How to develop mobile apps that come as close to the FDA line as possible, but don’t cross over into regulated territory.
- For those apps that FDA does regulate, how to figure out the appropriate classification in a system that frankly hasn’t been updated in a long time.
- If your app requires premarket clearance, what predicates are available and more importantly what strategies are there for showing substantial equivalence.
- Practical steps for developing an FDA quality system that is nuanced to fit mobile apps, and is designed to be as economical as possible.
- In a global economy, what are the differences between the US regulatory system and the EU system, and how can a company efficiently enter both markets?
- From the perspective of seasoned executives, what are the management challenges you can anticipate in mobile app development in a regulated environment?
You will hear directly from the experts, including regulatory attorneys, regulatory affairs specialists, quality system experts, European law attorneys, experienced mHealth executives and of course, the FDA.
Who Should Attend
These workshops will focus on mobile medical apps issues that will help both the novice and experienced FDA regulatory professional alike.
Contact
For questions about the MMA Roadshow, please contact:
Lisa Blackburn
lblackburn@ebglaw.com
Sponsors
University Sponsors
Bethany Hills will be presenting Beyond FDA: Overcoming Regulatory Hurdles on behalf of the mHealth Regulatory Coalition at the Inaugural MCT-Congress in Edinburgh, Scotland on March 21, 2014.
The MCT-Congress – a new cutting edge conference put together by the industry leaders – will explore the impact that mobile solutions are having on the clinical research process.
For more information: http://www.mct-congress.co.uk
March 12, 2013 in Philadelphia, PA at the Hub CityView from 7:30 am to 4:30 pm.
www.mobilehealthstrategyconference.com
December 8 – 11, 2013
Gaylord National Resort & Convention Center
Washington, DC
More information available here.
Bradley Merrill Thompson will speak at Wireless Health 2013, presented by Wireless-Life Sciences Alliance.
For more information, please visit WirelessHealth2013.org.
Bradley Merrill Thompson will present “Clarifying Plans for the Mobile Health App Regulation” at the MD&M Minneapolis Conference 2013, which runs from October 28 to 30.
For more information, visit CanonTradeShows.com.
Bradley Merrill Thompson presents “What Does the FDA Consider a Regulated App? Understanding the FDA’s Current Comments, Draft Guidance, ‘Enforcement Discretion’ and Definition of Accessories” during Medical Mobile Apps: An FDAnews Virtual Conference.
For more information, visit FDAnews.com.
September 28- October 2
Boston, MA
http://www.raps.org/education-amp-training/2013-raps.aspx
Every year, RAPS hosts The Regulatory Convergence, where people from industry, agencies and universities all over the world come together. They teach, learn, share ideas and make connections in a safe harbor environment, where the common denominator is an ambition to find out more and push things further.
These are your regulatory colleagues who work in research, clinical, pharma, medical devices, biologics, compliance, and at all different stages of the regulatory spectrum and product lifecycle. They’re specialists and CEOs, directors and statisticians. And The Regulatory Convergence is where they figure out how to turn drive into action.
Bradley Merrill Thompson will join a panel discussion on FDA oversight at the Radcliffe Exploratory Seminar on Mobile Health.
This seminar explores how mobile health technologies, including “medical apps” for smartphones and tablets, might change health care in the United States, including how we deliver, measure, consume, pay for, and regulate health care. It examines the legal, regulatory, and ethical implications from the perspective of various disciplines, including law, medicine, government, and public policy. Several federal agencies are actively involved in the mobile health space, and Congress is considering multiple bills to confront these technologies. This seminar provides an intense two-day discussion among experts in these fields in the hopes of generating inputs to help guide future policymaking and scholarship.
For more information, visit Radcliffe Exploratory Seminars.
Bradley Merrill Thompson will moderate a panel discussion, “How Technology Is Driving Communication: Social Media Vehicles,” at the Food and Drug Law Institute’s Advertising & Promotion Conference, which runs from September 16 to 17.
Although companies await guidance from FDA, they continue to use numerous social media vehicles to advertise and promote. This session will focus on the variety of vehicles that are available to companies (including well-known platforms like Facebook and newer models like Pinterest). Panelists will suggest ways to comply with existing FDA enforcement policies, and will provide advice on what practices seem beyond compliance.
For more information, visit FDLI.org.
