Market Access and Basics of Regulatory Affairs for Drug Discovery and MedTech Start-ups

Regulatory approval is a key focus area when working with new therapeutics, diagnostics or medtech devices. It is important to consider the path to regulatory approval early on. To introduce the regulatory aspects, AU TTO Business Development team and Open Entrepreneuship team from The Kitchen invites for a seminar where you can meet experts on regulatory approval in order to get familiar with the area and discuss you necessary steps you need to take in your own project.

When: September 15th 2020, 10.00-13.00.

Where:

Aarhus University - The Kitchen

Nørrebrogade 44

Bygning 1741 (15)

DK-8000 Aarhus C

*SIGN UP: When you sign up for the event, you have to choose which track you would like to participate in during the day. These tracks will be held after the introduction to the event. You can choose between two different tracks: Track 1 - Drug Discovery & Development or Track 2 - Medical Devices Track. 

*1:1 sessions: Moreover you have the opportunity to have a 1:1 session with the experts on your track. Choose this when you sign up for the event.

Program:

10:00 - 10.05:     Welcome to The Kitchen (Kitchen rep.)

10:05 - 10.10:     Introduction to the event (TTO BD team)

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Track 1: Drug Discovery & Development Track

10.15 - 11.15:     Regulatory aspects in Europe (EMA)

11:15 - 11.45:     Light lunch and networking

11:45 - 12.45:     Regulatory aspects in USA (FDA)

12:45 - 13.00:     Coffee and networking

13:00 - ?:            1:1 sessions with the experts (pre-booked)

Speaker: Anke Domdey, Ando Aps 

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Track 2: Medical Devices Track

10.15 - 11.15:     Regulatory landscape for market access
11:15 - 11.45:     Light lunch and networking
11:45 - 12.45:     Steps of medical device development

12:45 - 13.00:     Coffee and networking

13:00 - ?:            1:1 sessions with the experts (pre-booked)

Speaker: Medidee

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The Kitchen - Nørrebrogade 44 - 8000 - Aarhus C - cecilievan@au.dk