Masterclass: Regulation of DTx

November 3rd @ 4.00pm GMT+1/11.00am EDT
Digital Health Lunch

Masterclass: Regulation of DTx

November 3rd @ 4.00pm GMT+1/11.00am EDT
Digital Health Lunch

HealthXL virtual lunches convene small groups of thought leads and clients to share insights on key digital health issues. We welcome new experts and clients to join or host their own meetings. If you are interested in this topic, we would love to hear from you.

Through focus groups, we bring together 6-10 thought leaders and industry stakeholders in a series of virtual meetings to collaborate around a defined topic. Each meeting gives the group the opportunity to examine, analyze and collaborate with one another around a digital health topic as well as produce a shareable result.

Kal Patel
CEO & Co-Founder at BrightInsight
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Stephen Dunne
Chief Digital Therapeutics Officer (CDTxO) at Alpha
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Jamie Burgess
Vice President, Marketing, BrightInsight
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Elizabethann Lillie
Legal Secretary , Wright, Johnston & Mackenzie LLP
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Alan Dalton
Senior Manager Contracts and Reimbursement, HealthBeacon
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Aahuti Rai
Chief Strategy & Growth Officer at Ampersand Health
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Oliver Aalami
Director, Biodesign for Digital Health at Stanford Byers Center for Biodesign.
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Shwen Gwee
VP and Head of Global Digital Strategy at Bristol Myers Squibb
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Astrid Hannich-Walter
Director Business Model & Health Care Innovation, BI
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Kati (Saari) Kaijasilta
Business Development Director, Orion Corporation
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Join us for a masterclass focused on the regulation of DTx on November 3rd. Meet new people, gain insights and participate in a virtual event.

Digital Health Lunch
When:
November 3rd @ 4.00pm GMT+1/11.00am EDT
Register your interest
Registration Closed

This rapidly emerging industry of DTx needs to bring together regulators, engineers, practitioners, and companies to agree on standards that enable innovation. If a digital therapeutic treats a disease, it must be validated and regulated with the same rigor as a pharmacological drug. Led by biopharma and digital health industry veteran, Kal Patel, MD, CEO & Co-Founder, BrightInsight, this Masterclass will dive into the DTx regulatory landscape.


Key themes we'll explore:

  • What are the requirements of a Software as a Medical Device (SaMD)? 
  • What knowledge gaps exist that we can solve and share as a collective? 
  • Any good examples of companies that are doing this right? 
  • Any learnings from across ponds that may be applicable in other jurisdictions? 
  • How are de-centralized clinical trials regulated?

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Digital Health Lunch
When:
November 3rd @ 4.00pm GMT+1/11.00am EDT
Apply to Attend
Registration Closed

Attendees