Online event for Digital Health Application (DiGA) Manufacturers wishing to enter the French Market and all PECAN Enthusiasts.
Thursday, 16 November 2023
|16:00-16:10 Uhr||Greeting and Introduction |
Moderator: Jonas Albert _fbeta
|16:10-16:30 Uhr||Impulse |
What factors could motivate a DiGA manufacturer to venture into the French healthcare market?
France’s business potential from a DiGA-Company’s perspective
Downward Compatibility: DiGA fast-track to PECAN process
Speaker: Marisa Kaup German Digital Health Association (SVDGV)
|16:30-17:30 Uhr||Impulse |
Contrast between DiGA fast-track and PECAN process – how to successfully maneuver the reimbursement hurdles?
Topic 1: GAP analysis between PECAN and DiGA fast-track
What additional tasks are there for market access in France after successful DiGA listing?
Topic 2: Process
How does the PECAN process compare to the DiGA fast-track?
Topic 3: Product considerations
Which product types and features can be reimbursed under the PECAN process and what are the differences compared to the DiGA-Fast-Track?
Topic 4: Regulatory requirements
What are the regulatory requirements of the PECAN process and how do they relate to the DiGA fast-track?
Topic 5: Technical requirements
What are the technical prerequisites for the PECAN process?
Topic 6: Evidence requirements
To what extent is the German evidence gathered during the DiGA fast-track transferrable to the PECAN process?
Is it mandatory to initiate a new country specific study?
Topic 7: Reimbursement considerations
What interdependencies exist between the price regulations for reimbursement in Germany and France?
How do prices influence each other within the framework of reference pricing?
Speaker: Sophia Heyde _fbeta | Roman Spelsberg _fbeta
|17:30-18:00 Uhr||Questions & Wrap up|
Focus: Accessing the French Market with the PECAN Process: the way and the additional requirements you need to meet to introduce your Digital Health Applications (DiGA) in France. Compare the German and French fast-track programs and discover similarities and differences.
- DiGA vs. PECAN fast-track: Learn all about the differences between DiGA and the French PECAN fast-track program and how to adapt your product accordingly.
- Product Requirements: What specific requirements must your product meet to succeed in France? We’ll show you how your product should look to conquer the French Market.
- Regulatory Framework: Understand the regulatory aspects of the French healthcare system and how to navigate within it.
- Technical Aspects: Dive into the technical requirements and details you should know to introduce your DiGA in France.
- Evidence Proof: Learn how to provide evidence of the effectiveness of your DiGA in France.
- Pricing: Get acquainted with how pricing works in France and how to strategically set your price.
Don’t miss this unique opportunity to expand your knowledge and successfully launch your DiGA in the French market. Register now to secure your spot!
Participation is free of charge. You will receive the dial-in link to the e-mail address used for registration shortly before the event.