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09 Sep 2021 | 03:45 PM GMT
Past Meeting

Masterclass: The regulation of DTx in the US

Anchored by:

Kal Patel
CEO and Co-Founder
BRIGHTINSIGHT

Participants:

Kal Patel CEO and Co-FounderBrightInsightHealth Tech & Solutions
Health Tech & Solutions
Kal Patel
CEO and Co-FounderBrightInsight
AP
Acacia Parks Fractional Chief Science OfficerFound
AP
Acacia Parks
Fractional Chief Science OfficerFound
AL
Anders Loftgren OtherAstraZenecaOther
AL
Other
Anders Loftgren
OtherAstraZeneca
Bernhard Kappe Founder & CEOOrthogonal
Bernhard Kappe
Founder & CEOOrthogonal
Chris Cera CEOArcweb TechnologiesHealth Tech & Solutions
Health Tech & Solutions
Chris Cera
CEOArcweb Technologies
Dr. Nick (Nemanja) Kovacev Head of Healthcare and Life Sciences PracticeHTEC GroupHealth Tech & Solutions
Health Tech & Solutions
Dr. Nick (Nemanja) Kovacev
Head of Healthcare and Life Sciences PracticeHTEC Group
Ivan Jurisic Head of ProductPatients Influence
Ivan Jurisic
Head of ProductPatients Influence
Jo Masterson CEO2Morrow, Inc.Health Tech & Solutions
Health Tech & Solutions
Jo Masterson
CEO2Morrow, Inc.
Rob Trotta Executive Director, Business InnovationBoehringer Ingelheim Pharmaceuticals, IncLife Sciences, Pharma & Biotech
Life Sciences, Pharma & Biotech
Rob Trotta
Executive Director, Business InnovationBoehringer Ingelheim Pharmaceuticals, Inc
RG
Roy Grossberg AstraZeneca
RG
Roy Grossberg
AstraZeneca
Stephen Dunne Chief Product & Technology Officer - ManagingKoa HealthHealth Tech & Solutions
Health Tech & Solutions
Stephen Dunne
Chief Product & Technology Officer - ManagingKoa Health
Wen Dombrowski MD MBA Chief Convergence OfficerCATALAIZEInvestor & Accelerators
Investor & Accelerators
Wen Dombrowski MD MBA
Chief Convergence OfficerCATALAIZE
Zina Manji Founder/Principal, Regulatory StrategistInnopathwayz, LLCLife Sciences, Pharma & Biotech
Life Sciences, Pharma & Biotech
Zina Manji
Founder/Principal, Regulatory StrategistInnopathwayz, LLC

About this Meeting

Regulation is an absolute essential for DTx companies who want to be accepted into clinical and payer groups. What are the must know and do’s and don’ts when attempting to take your DTx product through regulatory pathways in the US? Join us in this Masterclass led by BrightInsight to learn more about:

  •  The evolution of the US regulatory regimes for SaMD: FDA Pre-Cert program 
  •  What should DTx companies go after as a SaMD maker - de novo, breakthrough device or classic 510k?  
  •  FDA Digital Health Center of Excellence (DHCoE): focus and roadmap 
  •  Changes expected in the US regulatory regimes for SaMD in the next 2 years

About Us

HLTH Inc. is a dynamic community delivering unique value to the healthcare industry through a mix of unparalleled global events, inspirational content, and impact-driven initiatives.

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USA Event Dates

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