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Drug-device combinations regulated as medicines - Revised regulatory framework with introduction of the new Medical Device Regulation from May 2020
Drug-device combinations regulated as medicines - Revised regulatory framework with introduction of the new Medical Device Regulation from May 2020

Presenter:
Lars Hyveled-Nielsen, Regulatory Project Director, Zealand Pharma

Teaser/Appetizer:

You are submitting either a new Marketing Authorization Application for a drug-device combination product regulated as a medicine or you are making substantial changes to the device component of your approved combination product after enforcement of the new EU Medical Device Regulation by May 2020:

- What should I do?
- When and what to expect from regulators in terms of regulatory guidance


Dato

Sted
28-01-2019 kl.:16.30 til kl.:18.30

Symbion, K3
Max antal deltagere: 30, der er 22 pladser tilbage
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  Tilmeldingsfrist: 25-01-2019   
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