Past Event: MedTech Innovation’s FDA and Regulatory Workshops

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Past Event: MedTech Innovation's FDA and Regulatory Workshops

Date: 23 Aug 2016, 13:00 - 16:30

Host: MedTech Innovation, COBIS (Room M10), Ole Maaløes Vej 3, 2200 Copenhagen N

Please note that the conference also took place 24 Aug 2016 in Aalborg!

Date: 24 Aug 2016, 13:00 – 16:30

Host: MedTech Innovation, Comwell Hvide Hus, Vesterbro 2, 9000 Aalborg

Are you an SME or Medtech Startup developing a new medical device? Have you ensured a US focus in your regulatory documentation, product design and reimbursement strategy and processes?

MedTech Innovation invites its members as well as non-members to a preliminary conference/workshop with three FDA and key persons from Minneapolis presenting their take on what is needed to succeed in gaining an FDA approval, conducting clinical trials and why Minneapolis is the hub to conduct this in. The event is also an opportunity to apply for an extended US development program, taking place in Minneapolis in connection with the Advamed conference 2016 in October.

Agenda

13.00
Welcome to Medtech Innovation

13.05
Introduction to the BSR program opportunity- Minneapolis trip etc.

13.15
Key-note 1: Minneapolis Medtech scene, companies, network, FDA etc.
Frank Jaskulke, Medical Alley Association 

13.45
Key-note 2: Small companies and regulatory pathways in the US – how do you overcome the hurdles?
Marcus Mianulli, Gnarus Consulting
Learn about market validations and more.

14.30
Break – Networking

14.45
Key-note 3: Newest trends in conducting clinical trials in relation to FDA approvals, fall-groups and setting up EU and US trials parallel
Mary Beth Hendersen, RCRI

15.30
Rounding up and next step for applying for Minneapolis program

15.35
Networking and 1-1 meetings with key-notes.

Sign up is closed now but was through Annette Rye Larsen on anryl@dtu.dk!

When signing up, you can already apply for the extended program in Minneapolis. Unsure of whether your company is ready and relevant for the extended development program? Feel free to contact Sofie Wandrup swa@sciondtu.dk or Annette Rye Larsen anryl@dtu.dk for further clarification.

Read more about the arrangement here.

 

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