Kiri

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

Failid

FW_ URGENT_Safety reporting requirements for Post-marketing (ICSR and Aggregate reports)_ Pre-marketing Medical Device Clinical .msg
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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):

 

  • 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

E: saikiran.topa@fortrea.com

M: +91 7093615048 | fortrea.com

 



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