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  3. Medical: Cardiology

Post Approval Study

Croatian translation: ispitivanje nakon odobrenja

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Post Approval Study
Croatian translation:ispitivanje nakon odobrenja
Entered by: V&E-Team

19:22 Dec 15, 2019
English to Croatian translations [PRO]
Medical - Medical: Cardiology / Pulse Generator
English term or phrase: Post Approval Study
The primary purpose of the S-ICD Post Approval Study is to document long term safety and effectiveness outcomes associated with the implantation of the equivalent first-generation S-ICD System in a clinical setting.

https://www.fda.gov/medical-devices/postmarket-requirements-...
V&E-Team
Croatia
Local time: 03:39
ispitivanje nakon odobrenja
Explanation:
Klinička ispitivanja nakon odobrenja obično podliježu brojnim promjenama. Te se promjene mogu odnositi na provođenje, plan, metodologiju, ispitivani lijek ili lijek usporedbe ili na ispitivača ili mjesto kliničkog ispitivanja u pitanju. Ako te promjene imaju znatan utjecaj na sigurnost ili prava ispitanika ili na pouzdanost i konzistentnost podataka dobivenih kliničkim ispitivanjem, one trebaju biti podložne postupku odobravanja koji je sličan prvotnom postupku odobravanja.
https://eur-lex.europa.eu/legal-content/HR/TXT/PDF/?uri=CELE...
Selected response from:

LogosART
Croatia
Local time: 03:39
Grading comment
puno hvala. lijep pozdrav ;-)
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1ispitivanje nakon odobrenja
LogosART


  

Answers


20 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
post approval study
ispitivanje nakon odobrenja


Explanation:
Klinička ispitivanja nakon odobrenja obično podliježu brojnim promjenama. Te se promjene mogu odnositi na provođenje, plan, metodologiju, ispitivani lijek ili lijek usporedbe ili na ispitivača ili mjesto kliničkog ispitivanja u pitanju. Ako te promjene imaju znatan utjecaj na sigurnost ili prava ispitanika ili na pouzdanost i konzistentnost podataka dobivenih kliničkim ispitivanjem, one trebaju biti podložne postupku odobravanja koji je sličan prvotnom postupku odobravanja.
https://eur-lex.europa.eu/legal-content/HR/TXT/PDF/?uri=CELE...

LogosART
Croatia
Local time: 03:39
Specializes in field
Native speaker of: Dutch
PRO pts in category: 23
Grading comment
puno hvala. lijep pozdrav ;-)

Peer comments on this answer (and responses from the answerer)
agree  ipv: A valjda. I EMA je naporna, ali FDA je vrh s approval vs. clearance vs. authorization :-)
17 hrs
  -> Hvala na agree-u i napomeni! Greetings!
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