USAEUROPEViVE
ABOUTSPONSORSHIPFOUNDATION
Logo Hlth
Logo Hlth

Participants:

Hicham Naim VP, Head of Strategy & TransformationTakeda
Hicham Naim
VP, Head of Strategy & TransformationTakeda
Stephen Gibney Snr Director - DPI SaaS Quality LeadPhilips
Stephen Gibney
Snr Director - DPI SaaS Quality LeadPhilips
Azran Osman-Rani CEONaluri
Azran Osman-Rani
CEONaluri
Blaise Jacholkowski Senior Business Manager, Digital HealthZuhlke Group
Blaise Jacholkowski
Senior Business Manager, Digital HealthZuhlke Group
Chris Cera CEOArcweb Technologies
Chris Cera
CEOArcweb Technologies
Dr. Nick (Nemanja) Kovacev Head of Healthcare and Life Sciences PracticeHTEC Group
Dr. Nick (Nemanja) Kovacev
Head of Healthcare and Life Sciences PracticeHTEC Group
Kendal Dinsmore VP, Quality Assurance / Regulatory AffairsMahana Therapeutics
Kendal Dinsmore
VP, Quality Assurance / Regulatory AffairsMahana Therapeutics
Liat Alon Country Comms & Patient Engagement HeadTakeda
Liat Alon
Country Comms & Patient Engagement HeadTakeda
Miron Derchansky Managing DirectorBlackletter Group
Miron Derchansky
Managing DirectorBlackletter Group
Stephen Dunne Chief Product & Technology Officer - ManagingKoa Health
Stephen Dunne
Chief Product & Technology Officer - ManagingKoa Health
Tai Chung VP of BD and Strategy, Deputy GCSempre Health
Tai Chung
VP of BD and Strategy, Deputy GCSempre Health
Vasyl Pyrozhyk Vice PresidentSMBC
Vasyl Pyrozhyk
Vice PresidentSMBC

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 USA and EU? Join us in this Masterclass led by BlueBridge Technologies to learn more about:
  • The evolution of the US and EU regulatory regimes for SaMD: Key similarities and differences between regimes MDR, FDA Pre-Cert program, MDSAP 
  • 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 and EU regulatory regimes for SaMD in the next few years