Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/4923-1 |
| Registreeritud | 07.05.2024 |
| Sünkroonitud | 08.05.2024 |
| Liik | Sissetulev dokument |
| Funktsioon | 11.2 Turustamise eelne järelevalve (pre-marketing surveillance) |
| Sari | 11.2-1 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus) |
| Toimik | 11.2-1/2024 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Amgen AB |
| Saabumis/saatmisviis | Amgen AB |
| Vastutaja | Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Bjorling, Johanna" <jbjorlin@amgen.com>
Sent: Mon, 06 May 2024 12:38:11 +0000
To: "mso@terviseamet.ee" <mso@terviseamet.ee>
Cc: "Carlens; Eva" <acarlens@amgen.com>; EU-Nordic Baltic Regulatory <nordic-baltic-regulatory@amgen.com>
Subject: Question regarding performance study application in Estonia
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Madam/Sir,
I have a general question regarding applications for performance studies. Once a performance study application has been submitted, will any of this information be made publicly available? We have noted that for example in the Netherlands certain information become accessible through registers and databases to potential study participants as well as other healthcare professionals.
Thank you in advance for your clarification.
Kind regards,
Johanna
Johanna Björling (she/her/hers)
CW Regulatory Affairs Associate
Local Regulatory Representative
mobile: +46 701 40 30 53
Amgen AB
Gustav III:s Boulevard 54
169 27 Solna, Sweden
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 07.05.2024 | 1 | 11.2-1/24/4923-2 | Väljaminev dokument | ta | Amgen AB |