Participants:

Dr. Stephani Chief of StaffHelloBetter

Dr. Stephani

Chief of StaffHelloBetter

Alex Russell Head of Digital PartnershipsTakeda Pharmaceuticals International AG

Life Sciences, Pharma & Biotech

Alex Russell

Head of Digital PartnershipsTakeda Pharmaceuticals International AG

Anand Trivedi ZSConsultant

Professional Services

Anand Trivedi

ZSConsultant

Aquil Harjivan Head of Front-End InnovationBayer Consumer Health

Life Sciences, Pharma & Biotech

Aquil Harjivan

Head of Front-End InnovationBayer Consumer Health

Ekaterina Ser DirectorMSD

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

Professional Services

Thibault Vandenhove

DirectorOoho

Tim Juergens PartnerCrossroad Biotech

Investor & Accelerators

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

Life Sciences, Pharma & Biotech

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.

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Masterclass: Navigating the DiGA Framework: a Case Study

Anchored by:

Participants:

About this Meeting

Featured:

Turning Patient Engagement into Brand, Business and Patient Outcomes

Sponsored by:

AI With Precision: Are We Ready to Act?

Sponsored by:

Featured:

VIP Pass: Connecting leaders to transform healthcare!

Executive Masterclass - The Great Health Recalibration (2027–2030): What Leaders Must Get Right Next

Featured:

Bridging Health Leadership Across the Ecosystem

Sponsored by:

Bridging Health Leadership Across the Ecosystem

Sponsored by:

Featured:

Featured:

‘This Was a Healthcare Election’: What Leaders Expect to Change After the Midterms

Masterclass: Navigating the DiGA Framework: a Case Study

Anchored by:

Participants:

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About this Meeting