Kiri

Dear Terviseamet,

I am reaching out to you with a few questions about the timelines we can expect for different IVDR submissions.

For one study, we likely need to submit an updated CPSP for an IVDR study. As it is not finalized yet, it is not clear if it will be submitted as a substantial modification or as a notification. I hope you can clarify the following:

1. If it will be submitted as a substantial modification, how many days can we expect to wait before we receive the approval from you?

2. If it will be submitted as a notification, do we need to wait for an approval or acknowledgement of receipt before implementing the change? If yes, how many days can we expect to wait before receiving this?

I would highly appreciate if you are able to respond to this before Tuesday 27AUG.

Thank you very much in advance!

Kind regards | Vänliga hälsningar 

Sofia Hogander, M.Sc. Pharm (she, her, hers)

FSP Clinical Trial Associate 2 | Nordic & Baltic Hub

Global Study Operations SM

m: +46 (0)76 136 43 11

e: [email protected]

Amgen AB

Gustav III:s Boulevard 54, 169 27 Solna, Sweden

www.amgen.com  

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