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Join FDA and DiMe during a 2-day virtual event to help advance the use of PGHD to support improved trials, medical device development products, and regulatory science!

Join the Virtual First Care Coalition to shape a healthcare system that's intentionally designed with patients at the center.

How to build a fit-for-purpose regulatory strategy to advance your business strategy


Date/Time

July 25, 2023

Panelists

Troy Tazbaz

Director, Digital Health Center of Excellence, FDA

Marisa Cruz

Chief Medical Officer, Empatica

Arrash Yassaee

Global Clinical Director, Huma Therapeutics

Moderator

Jen Goldsack

CEO, DiMe

Discussion Topic

Innovation is rapidly accelerating the use of digital health across various medical conditions. Yet, the current regulatory landscape can be difficult to navigate because regulatory science and requirements are ever-evolving within the digital health field. It’s difficult for innovators to know how to keep up. During this webinar, attendees will hear from regulatory and industry experts on keeping pace in this dynamic space.
You will learn how:

  • In today’s market, a fit-for-purpose regulatory strategy is a good business strategy.
  • Using resources available today – including online tools and a new education course – you can build a regulatory strategy to ensure that your digital health products meet necessary regulatory requirements.
  • Ensuring product safety and effectiveness are seen as more marketable and reliable by investors and payers, leading to more capital investment and a higher likelihood of payers’ acceptance.

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