Mike Benecky

Senior Director, Global Regulatory Affairs Precision and Digital Medicine GSK

Conference Day Two

Thursday, May 7th, 2020

3:20 PM Regulatory Considerations during Mobile Medical App Development for Commercial and Clinical Trial Use

• Understand why mobile medical apps are defined as medical devices from their intended use shown through labelling claims advertising materials, or oral or written statements
• Discuss how the mobile medical app regulation is health risk-based to balance patient safety and barriers to technological innovation
• Learn why medical device patient risk analysis is a critical activity prior to inclusion of digital tools within clinical trials
• Identify digital safety parameters including patient privacy, data cybersecurity and clinical risk due to app/sensor malfunction

Check out the incredible speaker line-up to see who will be joining Mike.

Download The Latest Agenda