Küsimused
| Dokumendiregister | Ravimiamet |
| Viit | MSO-13/1271-2 |
| Registreeritud | 11.03.2025 |
| Sünkroonitud | 12.03.2025 |
| Liik | Väljaminev kiri |
| Funktsioon | MSO Meditsiiniseadmed |
| Sari | MSO-13 Meditsiiniseadmete kliiniliste uuringute ja toimivusuuringute dokumendid (taotlused, load, muud teavitused ja kirjavahetus) |
| Toimik | MSO-13/2025 |
| Juurdepääsupiirang | Avalik |
| Juurdepääsupiirang | |
| Adressaat | Syneos Health |
| Saabumis/saatmisviis | Syneos Health |
| Vastutaja | Merili Saar-Abroi (RA, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: RA MSO <[email protected]>
Sent: Tue, 11 Mar 2025 14:23:03 +0000
To: "Martello; Daiana" <[email protected]>
Cc: SPVG Regulatory Intelligence <[email protected]>; RA MSO <[email protected]>
Subject: Vs: Clinical investigations with Medical Devices - Safety reporting email address
Dear Mrs. Martello,
Thank You for Your inquiry.
We confirm that the email address to submit safety reports arising from Clinical Investigations with Medical Devices is [email protected]
All the best,
Merili Saar-Abroi on behalf of
Department of Medical Devices
State Agency of Medicines
1 Nooruse Street
50411 Tartu
Estonia
Phone: +372 737 4140
www.ravimiamet.ee
Saatja: Martello, Daiana <[email protected]>
Saatmisaeg: esmaspäev, 10. märts 2025 13:02
Adressaat: RA MSO <[email protected]>
Koopia: SPVG Regulatory Intelligence <[email protected]>
Teema: Clinical investigations with Medical Devices - Safety reporting email address
Dear Sir/Madam,
I am a Safety Specialist at Syneos Health (Clinical Research Organization), a company responsible for Safety reporting on behalf of Sponsors in the frame of Clinical Investigations with Medical Devices and In Vitro Diagnostics (IVDs).
In the context of the announcement published on 1 January 2025 on the Ravimiamet website (link), we would like to confirm that the email address [email protected] can be used to submit safety reports arising from Clinical Investigations with Medical Devices.
Thanks in advance for your support.
Kind regards,
Daiana
Daiana Martello
Sr Safety & PV Ops Specialist
Syneos Health
Upcoming absence: 17-Apr-2025, 18-Apr-2025, 1-May-2025
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Küsimused | 11.03.2025 | 1 | MSO-13/1271-1 | Sissetulev kiri | ra | Syneos Health |