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Masterclass: The regulation of SaMD in Europe

29th March @ 10:45 AM EDT

Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!


Regulation is an absolute essential for digital health 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 SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:

  • Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies 
  • The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
  • Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
  • Changes expected in the European regulatory regimes for SaMD in the next few years

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Masterclass: The regulation of SaMD in Europe

Jim O'Donoghue
President , S3 Connected Health
Padraig Maguire
Head of Quality & Regulatory Affairs at S3 Connected Health
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Masterclass: The regulation of SaMD in Europe

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29th March @ 10:45 AM EDT

Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!


Regulation is an absolute essential for digital health 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 SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:

  • Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies 
  • The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
  • Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
  • Changes expected in the European regulatory regimes for SaMD in the next few years
Apply to AttendRegister to AttendApply to Attend

Participants

Participants

Jim O'Donoghue

President , S3 Connected Health

Padraig Maguire

Head of Quality & Regulatory Affairs at S3 Connected Health

Karine Soulat

Consultant, Wellthy Therapeutics

Tim Ruckh

Digital Health Clinical Data Collection Lead at AstraZeneca

Hicham Naim

Takeda

Ivan Jurisic

Founder/Business Consultant, Patients Influence

Jordi Lopez Almendros

Digital Business Partner, Chiesi

Brian Binkowski

Director of Quality, Twill

Rob Milnes

CEO, Fertility Focus

Aisling Murray

Sr. Director, Commercial Development, BrightInsight

Hans Middelhoven

Global VBHC leader, Roche

Number of Participants


Up to 12
Date  
March 29, 2022
Community

Masterclass: The regulation of SaMD in Europe

Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!


Regulation is an absolute essential for digital health 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 SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:

  • Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies 
  • The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
  • Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
  • Changes expected in the European regulatory regimes for SaMD in the next few years
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Masterclass: The regulation of SaMD in Europe

29th March @ 10:45 AM EDT
Digital Therapeutics (DTx)

Masterclass: The regulation of SaMD in Europe

29th March @ 10:45 AM EDT
Digital Therapeutics (DTx)
Jim O'Donoghue
President , S3 Connected Health
LinkedIn Profile
Padraig Maguire
Head of Quality & Regulatory Affairs at S3 Connected Health
LinkedIn Profile
Karine Soulat
Consultant, Wellthy Therapeutics
LinkedIn Profile
Tim Ruckh
Digital Health Clinical Data Collection Lead at AstraZeneca
LinkedIn Profile
Hicham Naim
Takeda
LinkedIn Profile
Ivan Jurisic
Founder/Business Consultant, Patients Influence
LinkedIn Profile
Jordi Lopez Almendros
Digital Business Partner, Chiesi
LinkedIn Profile
Brian Binkowski
Director of Quality, Twill
LinkedIn Profile
Rob Milnes
CEO, Fertility Focus
LinkedIn Profile
Aisling Murray
Sr. Director, Commercial Development, BrightInsight
LinkedIn Profile
Hans Middelhoven
Global VBHC leader, Roche
LinkedIn Profile

Masterclass: The regulation of SaMD in Europe

Are you trying to get your SaMD product regulated in Europe? Keep reading, this masterclass is for you!


Regulation is an absolute essential for digital health 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 SaMD product through regulatory pathways in Europe? Join us in this Masterclass led by S3 Connected Health to learn more about:

  • Overview of current regulations that govern the SaMD products in Europe & General requirements from regulatory bodies 
  • The evolution of Europe regulatory regimes for SaMD & Current classification: EU Medical Device Regulation (MDR) vs. the old Medical Device Directive (MDD) & Local Considerations (non-EU countries like the UK).
  • Recommended approach when engaging with European regulators: who to talk to, timelines constraints, etc.
  • Changes expected in the European regulatory regimes for SaMD in the next few years
When:
29th March @ 10:45 AM EDT
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