Dokumendiregister | Terviseamet |
Viit | 11.2-1/24/7978-1 |
Registreeritud | 06.08.2024 |
Sünkroonitud | 07.08.2024 |
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 | Fortrea |
Saabumis/saatmisviis | Fortrea |
Vastutaja | Merili Saar-Abroi (TA, Peadirektori asetäitja (1) vastutusvaldkond, Meditsiiniseadmete osakond) |
Originaal | Ava uues aknas |
From: Ravimiamet <info@ravimiamet.ee>
Sent: Wed, 31 Jul 2024 11:04:19 +0000
To: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Subject: FW: URGENT_Safety reporting requirements for Post-marketing (ICSR and Aggregate reports)/ Pre-marketing Medical Device Clinical Trials in Estonia
Tere
Edastan pöördumise.
Heade soovidega
Kärolin Jenas
Ravimiamet
arendus- ja haldusosakonna dokumendihalduse spetsialist
Telefon 737 4140
karolin.jenas@ravimiamet.ee
Nooruse 1
50411 Tartu
www.ravimiamet.ee
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From: Topa, Sai Kiran <saikiran.topa@fortrea.com>
Sent: kolmapäev, 31. juuli 2024 14:01
To: Ravimiamet <info@ravimiamet.ee>
Cc: Kota, Narendrakumar <narendrakumar.kota@fortrea.com>; Mukherjee, Dalina <Dalina.Mukherjee@fortrea.com>; Chevalier, Aleksandra <Aleksandra.Chevalier@fortrea.com>
Subject: URGENT_Safety reporting requirements for Post-marketing (ICSR and Aggregate reports)/ Pre-marketing Medical Device Clinical Trials in Estonia
Dear Sir/ Madam,
Hope this email finds you well.
Could you please provide us the contact information (preferably email) for regulatory authority and Pharmacovigilance for Estonia.
In addition, could you please provide the following information for post-marketing Medical device Clinical Trials in Estonia.
Post-marketing Medical Device Clinical Trials (AGGR requirements):
Thanks & Regards
Sai Kiran Topa
Safety Science Analyst
M: +91 7093615048 | fortrea.com
Fortrea
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Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
---|---|---|---|---|---|---|
Kiri | 07.08.2024 | 1 | 11.2-1/24/7978-4 | Väljaminev dokument | ta | Fortrea |
Kiri | 07.08.2024 | 1 | 11.2-1/24/7978-3 | Sissetulev dokument | ta | Fortrea |
Vastuskiri | 06.08.2024 | 1 | 11.2-1/24/7978-2 | Väljaminev dokument | ta | Fortrea |