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02 Nov 2022 | 10:00 AM GMT

Masterclass: Navigating the DiGA Framework: a Case Study

Anchored by:

Dr. Stephani
Chief of Staff
HELLOBETTER

Participants:

Dr. Stephani Chief of StaffHelloBetter
Dr. Stephani
Chief of StaffHelloBetter
Alex Russell Director Digital PartnershipsTakeda Pharmaceuticals
Alex Russell
Director Digital PartnershipsTakeda Pharmaceuticals
Anand Trivedi ZSConsultant
Anand Trivedi
ZSConsultant
Aquil Harjivan Head of Front-End InnovationBayer Consumer Health
Aquil Harjivan
Head of Front-End InnovationBayer Consumer Health
ES
Ekaterina Ser DirectorMSD
ES
Ekaterina Ser
DirectorMSD
Emma Carr Co-Founder and Chief Scientific OfficerAmara Therapeutics
Emma Carr
Co-Founder and Chief Scientific OfficerAmara Therapeutics
Sofoklis Kyriazakos CEOInnovation Sprint Sprl
Sofoklis Kyriazakos
CEOInnovation Sprint Sprl
Thibault Vandenhove DirectorOoho
Thibault Vandenhove
DirectorOoho
Tim Juergens PartnerCrossroad Biotech
Tim Juergens
PartnerCrossroad Biotech
Valentine Emmanuel Experience Design & Strategy LeadDaiichi Sankyo
Valentine Emmanuel
Experience Design & Strategy LeadDaiichi Sankyo
Zina Manji Founder/Principal, Regulatory StrategistInnopathwayz, LLC
Zina Manji
Founder/Principal, Regulatory StrategistInnopathwayz, LLC

About this Meeting

Regulatory clearance and the right commercialization model for a digital health product are key components of success in this rapidly growing space. Germany’s  Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV) have the potential to play a key role in not only providing a path to reimbursement, but also for increasing provider awareness and trust in digital health solutions.  

What do you need to know to navigate the DiGA framework? Join us in this interactive masterclass led by Dr. Victor Stephani (responsible for Market Access and Chief of Staff at HelloBetter), who will walk us through:  

  • General overview: what DiGA is and what it’s not, why it is an opportunity for digital health companies in the European market. 
  • Evidence and product requirements: what are the evidence requirements for permanent vs. probational listing? What are the requirements around data security, UX, interoperability, and other product-related aspects? 
  • Corresponding with BfArM and how to report significant changes in the product.  
  • Manufacturer’s price vs. negotiated price. How do the pricing negotiations work? What is the best pricing strategy for digital health companies?

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.