Kiri
| Dokumendiregister | Terviseamet |
| Viit | 11.2-1/24/7978-3 |
| Registreeritud | 07.08.2024 |
| Sünkroonitud | 08.08.2024 |
| 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 |
Failid
From: "Topa, Sai Kiran" <saikiran.topa@fortrea.com>
Sent: Wed, 07 Aug 2024 08:00:05 +0000
To: "Meditsiiniseadmed (Medical Devices)" <mso@terviseamet.ee>
Cc: "Kota; Narendrakumar" <narendrakumar.kota@fortrea.com>; "Mukherjee; Dalina" <Dalina.Mukherjee@fortrea.com>; "Chevalier; Aleksandra" <Aleksandra.Chevalier@fortrea.com>
Subject: RE: URGENT_Safety reporting requirements for Post-marketing (ICSR and Aggregate reports)/ Pre-marketing Medical Device Clinical Trials in Estonia
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Tähelepanu! Tegemist on väljastpoolt asutust saabunud kirjaga. Tundmatu saatja korral palume linke ja faile mitte avada. |
Dear Merili Saar-Abroi,
"By Aggregate report we mean any kind of report, for example Annual Safety Report, Periodic Line Listing Report etc. Thank you for your time. A prompt response would be highly appreciated."
Thanks & Regards
Sai Kiran Topa
Safety Science Analyst
M: +91 7093615048 | fortrea.com
From: Meditsiiniseadmed (Medical Devices) <mso@terviseamet.ee>
Sent: Tuesday, August 6, 2024 5:33 PM
To: Topa, Sai Kiran <saikiran.topa@fortrea.com>
Cc: Kota, Narendrakumar <narendrakumar.kota@fortrea.com>; Mukherjee, Dalina <Dalina.Mukherjee@fortrea.com>; Chevalier, Aleksandra <Aleksandra.Chevalier@fortrea.com>
Subject: Vs: URGENT_Safety reporting requirements for Post-marketing (ICSR and Aggregate reports)/ Pre-marketing Medical Device Clinical Trials in Estonia
Dear Sai Kiran,
Thank You for Your enquiry.
The medical device regulations do not specify such term as ’aggregate report’. Please specify the questions nature as per medical device regulations terminology.
All the best,
Merili Saar-Abroi
peaspetsialist
meditsiiniseadmete osakond
+372 554 3041
merili.saar-abroi@terviseamet.ee | mso@terviseamet.ee
|
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Terviseamet +372 794 3500 info@terviseamet.ee
Paldiski mnt 81, 10614 Tallinn |
Käesolev kiri on konfidentsiaalne ning mõeldud kasutamiseks kirja päises nimetatud isikule/asutusele. Käesoleva kirja mistahes viisil kasutamine või kopeerimine isiku poolt, kes ei ole märgitud selle adressaadiks, on keelatud. Kui te olete saanud käesoleva kirja ekslikult, palume sellest koheselt teavitada kirja saatjat ning kustutada saadud kiri koos kõikide lisadega.
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):
- Destination (Agency Name):
-
Requirements:
- Aggregate Report Type:
- Timelines:
- Translation required for Aggregate Reports in regional language ? (Yes/No)
Thanks & Regards
Sai Kiran Topa
Safety Science Analyst
M: +91 7093615048 | fortrea.com
Fortrea
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Seosed
| Nimi | K.p. | Δ | Viit | Tüüp | Org | Osapooled |
|---|---|---|---|---|---|---|
| Kiri | 07.08.2024 | 1 | 11.2-1/24/7978-4 | Väljaminev dokument | ta | Fortrea |
| Kiri | 06.08.2024 | 1 | 11.2-1/24/7978-1 | Sissetulev dokument | ta | Fortrea |
| Vastuskiri | 06.08.2024 | 1 | 11.2-1/24/7978-2 | Väljaminev dokument | ta | Fortrea |