An estimated two thirds of the medical technology manufactured in Germany is exported - and the top target countries are the USA and China outside of Europe. But as important as the international markets are, the paths to bringing products onto the market there are sometimes rocky. The MedicalMountains GmbH symposium focuses on questions of international approvals. On the one hand from a pragmatic point of view with tips and recommendations at workshops, on the other hand from the overarching perspective of how harmonization can succeed, Europe can learn from others and digitization can help with the processes.
Some of the lectures will be held in English.
The program is continuously updated.
The participation fee is €320.00 (plus VAT). Members of TechnologyMountains eV or the Med Alliance only pay €220.00 (plus VAT).
Procedure ► Thursday, March 23 2:30 p.m.: Greeting // WelcomeJulia Steckeler & Meinrad Kempf, MedicalMountains GmbH
2:45 p.m.: Approval of medical devices in selected target markets - where are the changes? // Approval of medical devices in selected target markets - where are the changes?tbd.
3:30 p.m.: International approvals of medical devices - from challenge to opportunity // International approvals of medical devices - from challenge to opportunitytbd.
4:00 p.m.: Intermission // Break 4:30 p.m.: International harmonization? Can the nIVD MA ToC show the way? // International harmonization? Can nIVD MA ToC lead the way?tbd.
5:00 p.m. Q&A session // Q&A session MedicalMountains GmbH, speakers and experts from companies from the MedicalMountains
MedicalMountains GmbH, speakers and experts from companies out of the MedicalMountains
Julia Steckeler & Meinrad Kempf, MedicalMountains GmbH
08:45: The FDA's eStar process - a model for Europe?Patrick Axtell, FDA
9:30 a.m.: Best practice - new approaches // Best practice or new approachestbd.
10:00 a.m. Recommendations and practical tips (workshops in groups) // Recommendations and practical tips (workshops in groups) Group 1 // Group 1:
How can more countries be included in the approval process? Development of a global strategy according to the IMDRF principles.
How to integrate more countries into the approval process? Build a global strategy according to IMDRF principles.
(Veeva Systems Inc.)
Group 2 // Group 2:
Information flow within an organization
Information flow within an organization
(Veeva Systems Inc.)
Group 3 // Group 3:
tbd.
KONTAKT:
Königstraße 39, TuttlingenStadthalle Tuttlingen
