Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/4777-1 |
| Registreeritud | 03.05.2024 |
| Sünkroonitud | 06.05.2024 |
| 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 | Syneos Health |
| Saabumis/saatmisviis | Syneos Health |
| Vastutaja | Sofia Ratušnaja (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
| Originaal | Ava uues aknas |
Failid
From: "Sabatini Martin, Ana Rosa" <[email protected]>
Sent: Tue, 30 Apr 2024 13:05:33 +0000
To: "[email protected]" <[email protected]>
Cc: SPVG Regulatory Intelligence <[email protected]>
Subject: Estonia_Question on safety reporting in clinical studies with Medical Devices & IVDs
|
Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Sr/Madam:
Syneos Health (Clinical Research Organization) is responsible for the safety reporting on behalf of Sponsors in the frame of Clinical Investigations with Medical Devices and Performance Studies with In Vitro Diagnostics (IVDs);
We would much appreciate if you could please provide with your feedback to my question below:
- The EU MDR & IVDR do not specify Sponsor safety reporting obligations to investigational sites. Therefore, it is assumed that the Sponsor does not need to submit safety reports to investigational sites unless specified by the Clinical Investigational Plan/Performance Study Plan.
Could you please confirm your alignment with the above statement?
Thank you so much for all your support.
Best regards,
Ana Rosa
Ana Rosa Sabatini Martín
Sr QPPV Office Specialist
Drug Safety & Pharmacovigilance
Spain – Home Based
Phone +34 914 23 07 50
Email: [email protected]
Syneos Health, (the “Company”). This email and any files transmitted may contain information that is privileged, confidential and exempt from disclosure and is intended solely for the intended recipient. If you received this email in error, please inform the sender and delete it. This email neither constitutes an agreement to conduct transactions by electronic means nor creates any legally binding contract or enforceable obligation in the absence of a fully signed written contract. Any views or opinions expressed are solely those of the author and do not necessarily represent those of the Company. Although the Company has taken reasonable precautions to ensure no viruses are present in this email, the Company cannot accept responsibility for any loss or damage arising from the use of this email or attachments.
Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Vastuskiri | 06.05.2024 | 1 | 11.2-1/24/4777-3 | Sissetulev dokument | ta | Syneos Health |
| Vastuskiri | 06.05.2024 | 1 | 11.2-1/24/4777-4 | Väljaminev dokument | ta | Syneos Health |
| Vastuskiri | 03.05.2024 | 3 | 11.2-1/24/4777-2 | Väljaminev dokument | ta | Syneos Health |