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11 May 2023 | 02:45 PM GMT

Masterclass: When and how should your digital health solution be regulated?

Anchored by:

Acacia Parks
VP Regulatory Compliance and Engineering
AVANIA

Participants:

Acacia Parks VP Regulatory Compliance and EngineeringAvania
Acacia Parks
VP Regulatory Compliance and EngineeringAvania
Tessy Huss Director of Strategy , HLTH CommunityHLTH Community
Tessy Huss
Director of Strategy , HLTH CommunityHLTH Community
Anna-Maria Heidinger Head of Digital Innovation HubDaiichi Sankyo Europe
Anna-Maria Heidinger
Head of Digital Innovation HubDaiichi Sankyo Europe
Ashutosh Malhotra Director Digital Health Strategy & PartnersDaiichi Sankyo
Ashutosh Malhotra
Director Digital Health Strategy & PartnersDaiichi Sankyo
Chris Cera CEOArcweb Technologies
Chris Cera
CEOArcweb Technologies
Gazal Vakili Director, Digital Health InnovationDainippon Sumitomo Pharma
Gazal Vakili
Director, Digital Health InnovationDainippon Sumitomo Pharma
Harvey Castro Chief Clinical Operating OfficerViTel Health
Harvey Castro
Chief Clinical Operating OfficerViTel Health
Jessica Lake Director of Medical AffairsBig Health
Jessica Lake
Director of Medical AffairsBig Health
Jordan Silberman Dir of Clinical Analytics & ResearchElevance Health
Jordan Silberman
Dir of Clinical Analytics & ResearchElevance Health
Marta Sole Venture Innovation ManagerMon Clinic
Marta Sole
Venture Innovation ManagerMon Clinic
Patrick Leyseele Founder3.life
Patrick Leyseele
Founder3.life
Paula Salme Sandrak Digital Health Product StrategistBayer AG
Paula Salme Sandrak
Digital Health Product StrategistBayer AG
Rick Bartels President/Founder DTxCC
Rick Bartels
President/Founder DTxCC
Ventsislav Dobrev Global Clinical Lead Digital BiomarkersRoche
Ventsislav Dobrev
Global Clinical Lead Digital BiomarkersRoche

About this Meeting

Each Masterclass is led by an expert anchor in their field as they dive into their specialty topic in front of a small intimate audience of 8-12 participants. Masterclasses also have an interactive element, allowing you a safe space to share your thoughts and experiences as well as pose questions to the expert anchors.

Do you need guidance on the best practices for gaining regulatory approval for your digital health solution? Then this masterclass is the perfect fit for you!
In the ever-evolving field of digital health, navigating the regulatory landscape can be daunting. Fortunately, Dr. Acacia Parks (Lead Consultant and Founder at Liquid Amber Consulting) is here to answer your questions, bring clarity to the regulatory landscape, and guide you on best practices for regulating your digital solution. Join this masterclass where Acacia will share her expertise and learnings to the following:
  • What are the different regulatory categories for digital health products?
  • What are the key factors that affect which category a product falls under?
  • What are the compliance and regulatory/evidence requirements for products in each category?
  • What are the commercial differences for each category (e.g. price point, commercial pathways, flexibility, etc.)?
We would like to remind you that our meetings are small and intimate sessions with a limited number of seats available, therefore we rely on your attendance and participation to ensure a high quality and valuable meeting for all. If you are confirmed for this meeting we ask if you can please ensure your attendance on the day.