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Masterclass: Regulation of DTx in the US - Experience from a Real Company

7th September @ 10:45AM EDT

Are you trying to get your DTx solution regulated in the US? Would you like to learn from the experiences of a real company? Keep reading, this masterclass is for you!

Having regulatory clearance is absolutely essential for many DTx companies to successfully bring their solution to market. Most times, knowing what is on the books is not enough to understand how you should navigate the regulatory landscape in practice. In this masterclass, we will hear about the experience from a real company; Michelle Rubin-Onur, Director of Regulatory at Blue Note Therapeutics, will walk us through the following: 

  • Regulatory pathways for SaMD in the US and how to approach the discussions with the FDA
  • Enforcement discretion in place during the public health emergency: what should companies do when it goes away? How to plan for that?
  • Clinical studies: how can you evaluate or consider endpoints for your solution and incorporate FDA's feedback into clinical studies? 
  • SaMD continuous improvement: what are the regulatory implications? How can companies deal with that efficiently?

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Masterclass: Regulation of DTx in the US - Experience from a Real Company

Michelle Rubin-Onur
Director of Regulatory, Blue Note Therapeutics
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
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Masterclass: Regulation of DTx in the US - Experience from a Real Company

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7th September @ 10:45AM EDT

Are you trying to get your DTx solution regulated in the US? Would you like to learn from the experiences of a real company? Keep reading, this masterclass is for you!

Having regulatory clearance is absolutely essential for many DTx companies to successfully bring their solution to market. Most times, knowing what is on the books is not enough to understand how you should navigate the regulatory landscape in practice. In this masterclass, we will hear about the experience from a real company; Michelle Rubin-Onur, Director of Regulatory at Blue Note Therapeutics, will walk us through the following: 

  • Regulatory pathways for SaMD in the US and how to approach the discussions with the FDA
  • Enforcement discretion in place during the public health emergency: what should companies do when it goes away? How to plan for that?
  • Clinical studies: how can you evaluate or consider endpoints for your solution and incorporate FDA's feedback into clinical studies? 
  • SaMD continuous improvement: what are the regulatory implications? How can companies deal with that efficiently?

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Participants

Participants

Michelle Rubin-Onur

Director of Regulatory, Blue Note Therapeutics

Jordan Silberman, MD, PhD

Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.

Lynda Chin

Founder, President and CEO, Apricity Health

Rayna Patel

Co-Founder and CEO, Vinehealth

Anneleen Vyncke

Digital Transformation Project Lead, UCB

Richard Bunney

Digital Health Regulation and Compliance Lead, ETHOS Ltd

Brittany Johnson

Marketing Manager, Decimal Health

Emma Carr, PhD

Co-Founder and CSO, Amara Therapeutics

Maxime Champain

Lead, BDH External Innovation & Alliances, Search & Evaluation, Biogen

Gal Nachum

Co-Founder & Active Chairman, CogniShape

Andrew Norden

Chief Medical Officer, OncoHealth

Number of Participants


Up to 12
Date  
September 7, 2022
Community

Masterclass: Regulation of DTx in the US - Experience from a Real Company

Are you trying to get your DTx solution regulated in the US? Would you like to learn from the experiences of a real company? Keep reading, this masterclass is for you!

Having regulatory clearance is absolutely essential for many DTx companies to successfully bring their solution to market. Most times, knowing what is on the books is not enough to understand how you should navigate the regulatory landscape in practice. In this masterclass, we will hear about the experience from a real company; Michelle Rubin-Onur, Director of Regulatory at Blue Note Therapeutics, will walk us through the following: 

  • Regulatory pathways for SaMD in the US and how to approach the discussions with the FDA
  • Enforcement discretion in place during the public health emergency: what should companies do when it goes away? How to plan for that?
  • Clinical studies: how can you evaluate or consider endpoints for your solution and incorporate FDA's feedback into clinical studies? 
  • SaMD continuous improvement: what are the regulatory implications? How can companies deal with that efficiently?

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Masterclass: Regulation of DTx in the US - Experience from a Real Company

7th September @ 10:45AM EDT
Digital Therapeutics (DTx)

Masterclass: Regulation of DTx in the US - Experience from a Real Company

7th September @ 10:45AM EDT
Digital Therapeutics (DTx)
Michelle Rubin-Onur
Director of Regulatory, Blue Note Therapeutics
LinkedIn Profile
Jordan Silberman, MD, PhD
Director of Clinical Analytics and Research, Digital Care Delivery, Anthem, Inc.
LinkedIn Profile
Lynda Chin
Founder, President and CEO, Apricity Health
LinkedIn Profile
Rayna Patel
Co-Founder and CEO, Vinehealth
LinkedIn Profile
Anneleen Vyncke
Digital Transformation Project Lead, UCB
LinkedIn Profile
Richard Bunney
Digital Health Regulation and Compliance Lead, ETHOS Ltd
LinkedIn Profile
Brittany Johnson
Marketing Manager, Decimal Health
LinkedIn Profile
Emma Carr, PhD
Co-Founder and CSO, Amara Therapeutics
LinkedIn Profile
Maxime Champain
Lead, BDH External Innovation & Alliances, Search & Evaluation, Biogen
LinkedIn Profile
Gal Nachum
Co-Founder & Active Chairman, CogniShape
LinkedIn Profile
Andrew Norden
Chief Medical Officer, OncoHealth
LinkedIn Profile

Masterclass: Regulation of DTx in the US - Experience from a Real Company

Are you trying to get your DTx solution regulated in the US? Would you like to learn from the experiences of a real company? Keep reading, this masterclass is for you!

Having regulatory clearance is absolutely essential for many DTx companies to successfully bring their solution to market. Most times, knowing what is on the books is not enough to understand how you should navigate the regulatory landscape in practice. In this masterclass, we will hear about the experience from a real company; Michelle Rubin-Onur, Director of Regulatory at Blue Note Therapeutics, will walk us through the following: 

  • Regulatory pathways for SaMD in the US and how to approach the discussions with the FDA
  • Enforcement discretion in place during the public health emergency: what should companies do when it goes away? How to plan for that?
  • Clinical studies: how can you evaluate or consider endpoints for your solution and incorporate FDA's feedback into clinical studies? 
  • SaMD continuous improvement: what are the regulatory implications? How can companies deal with that efficiently?

When:
7th September @ 10:45AM EDT
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