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29 Mar 2022 | 02:45 PM GMT

Masterclass: The regulation of SaMD in Europe

Anchored by:

Jim O'Donoghue
President
S3 CONNECTED HEALTH

Participants:

Jim O'Donoghue PresidentS3 Connected Health
Jim O'Donoghue
PresidentS3 Connected Health
Aisling Murray Vice President, CommercialHuma
Aisling Murray
Vice President, CommercialHuma
Bailu Lu R&D External Innovation & PartneringBayer AG
Bailu Lu
R&D External Innovation & PartneringBayer AG
BB
Brian Binkowski Director of QualityTwill
BB
Brian Binkowski
Director of QualityTwill
Cathy Zaremba Director, Product MarketingBrightInsight
Cathy Zaremba
Director, Product MarketingBrightInsight
Hans Middelhoven Global Value-Based HealthCare LeaderRoche Hoffman
Hans Middelhoven
Global Value-Based HealthCare LeaderRoche Hoffman
JL
Jordi López Digital Business PartnerChiesi
JL
Jordi López
Digital Business PartnerChiesi
Jorge Lopez Almendros Chiesi
Jorge Lopez Almendros
Chiesi
Karine Soulat Marketing Consultant on health and e healthKe-Health
Karine Soulat
Marketing Consultant on health and e healthKe-Health
Katie Cannon Director - Strategic PartnershipsAvegen Health
Katie Cannon
Director - Strategic PartnershipsAvegen Health
LL
Lori Leathers Business DevelopmentCurebase
LL
Lori Leathers
Business DevelopmentCurebase
Padraig Maguire Head of Quality & Regulatory AffairsS3 Connected Health
Padraig Maguire
Head of Quality & Regulatory AffairsS3 Connected Health
Tim Ruckh Digital Health Clinical Data Collection LeadAstraZeneca
Tim Ruckh
Digital Health Clinical Data Collection LeadAstraZeneca

About this Meeting

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