Digital Health Tools: What YOU Need to Know - Webinar Recording/Transcript

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Digital Health Tools: What YOU Need to Know — Prepare now for the FDA’s Transformative Project

The FDA is moving fast into development of digital health tools. The moves promise competitive advantage to the drug, biologics, device and combo products makers who position themselves to take advantage … and new regulatory and compliance issues as well.

With technology changing at lightning speed, there’s a lot to learn – and not much time to learn it. If you plan to reap the benefits, listen up.

Noted Washington FDA lawyer Bradley Merrill Thompson Esq. of Epstein Becker & Green P.C. outlines what the agency has done to date … and what it plans in months to come. Over the course of 90 fast-paced minutes, he’ll fill you in on:

  • AI-powered clinical decision support software: How a recent FDA approval could affect you
  • The “Working Model”: The agency’s master plan for implementation
  • “Pre Cert 1.0”: What the first version may look like by late 2018
  • Drug development and digital tools: How the FDA is expanding opportunities and enabling patient-care innovations
  • Post-market surveillance: The varied roles smart tools may play
  • Cooperation with industry: Moves the FDA is making and mulling
  • Artificial intelligence: The FDA’s new approach
  • Pre-market digital safety: A new FDA program launches
  • Digital Health Incubator: Another new FDA program launch
  • And MUCH more!

Smartphones and digital apps already have given consumers powerful tools to take control of their own health. The changes affecting the FDA-regulated manufacturing community will dwarf these. You need to get up to speed, and fast.

This presentation is directed at makers of drugs, biologics, medical devices and combination products. It will be particularly useful to the following executives and professionals: 

  • C-suite
  • QA/QR/QC
  • Regulatory affairs
  • Compliance affairs
  • Strategic planning
  • Marketing/sales
  • General counsel/outside counsel
  • Digital health consultants

Bradley Merrill Thompson Esq., Epstein Becker & Green P.C., counsels device, drug, and combination product companies on a wide range of FDA regulatory, reimbursement and clinical-trial issues. Mr. Thompson regularly defends companies receiving warning letters on subjects including good manufacturing practice, compliance and off label promotion.