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  3. Medical (general)

dirimenti

English translation: decisive

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Italian term or phrase:dirimenti
English translation:decisive
Entered by: Shera Lyn Parpia

08:04 Feb 10, 2016
Italian to English translations [PRO]
Law/Patents - Medical (general) / AIFA regulations
Italian term or phrase: dirimenti
it is found here:
http://www.agenziafarmaco.gov.it/it/content/qualità-e-gmp-fa...
and this is the sentence:

Quest’ultimo requisito, in particolare, non può ritenersi soddisfatto con indicazioni approssimative e generiche; le motivazioni per considerare la modifica sostanziale, infatti, devono essere formulate specificamente ed esattamente, con riferimento agli elementi indicati — e all’uopo dirimenti — dal Decreto Legislativo 24 giugno 2003, n. 211 e dal Decreto Ministeriale 21 dicembre 2007.

Thanks!
Shera Lyn Parpia
Italy
Local time: 21:04
decisive
Explanation:

http://unaparolaalgiorno.it/significato/D/dirimente

L'argomento dirimente è quello che da solo basta a risolvere una questione, che non necessita di altri argomenti satelliti d'appoggio;



--------------------------------------------------
Note added at 9 hrs (2016-02-10 17:48:23 GMT)
--------------------------------------------------

Requests to make substantial emendments can't be vague or general but need to be justified with specific reference to the details listed in that law (art.6 para 3 EN) //(art. 6 para 2 IT). See below

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:320...
http://www.camera.it/parlam/leggi/deleghe/03211dl.htm

Article 10

Conduct of a clinical trial

Amendments may be made to the conduct of a clinical trial following the procedure described hereinafter:

(a) after the commencement of the clinical trial, the sponsor may make amendments to the protocol. If those amendments are substantial and are likely to have an impact on the safety of the trial subjects or to change the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant, the sponsor shall notify the competent authorities of the Member State or Member States concerned of the reasons for, and content of, these amendments and shall inform the ethics committee or committees concerned in accordance with Articles 6 and 9.

On the basis of the details referred to in Article 6(3) and in accordance with Article 7, the Ethics Committee shall give an opinion within a maximum of 35 days of the date of receipt of the proposed amendment in good and due form. If this opinion is unfavourable, the sponsor may not implement the amendment to the protocol.
Selected response from:

JudyC
Italy
Local time: 21:04
Grading comment
Thank you.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1decisive
JudyC
3disqualifying (disqualifications)
Gad Kohenov


  

Answers


29 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
disqualifying (disqualifications)


Explanation:
Puo darsi.

Gad Kohenov
Israel
Local time: 22:04
Specializes in field
Native speaker of: Native in FrenchFrench, Native in HebrewHebrew
PRO pts in category: 80
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
decisive


Explanation:

http://unaparolaalgiorno.it/significato/D/dirimente

L'argomento dirimente è quello che da solo basta a risolvere una questione, che non necessita di altri argomenti satelliti d'appoggio;



--------------------------------------------------
Note added at 9 hrs (2016-02-10 17:48:23 GMT)
--------------------------------------------------

Requests to make substantial emendments can't be vague or general but need to be justified with specific reference to the details listed in that law (art.6 para 3 EN) //(art. 6 para 2 IT). See below

http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex:320...
http://www.camera.it/parlam/leggi/deleghe/03211dl.htm

Article 10

Conduct of a clinical trial

Amendments may be made to the conduct of a clinical trial following the procedure described hereinafter:

(a) after the commencement of the clinical trial, the sponsor may make amendments to the protocol. If those amendments are substantial and are likely to have an impact on the safety of the trial subjects or to change the interpretation of the scientific documents in support of the conduct of the trial, or if they are otherwise significant, the sponsor shall notify the competent authorities of the Member State or Member States concerned of the reasons for, and content of, these amendments and shall inform the ethics committee or committees concerned in accordance with Articles 6 and 9.

On the basis of the details referred to in Article 6(3) and in accordance with Article 7, the Ethics Committee shall give an opinion within a maximum of 35 days of the date of receipt of the proposed amendment in good and due form. If this opinion is unfavourable, the sponsor may not implement the amendment to the protocol.

JudyC
Italy
Local time: 21:04
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in ItalianItalian
PRO pts in category: 533
Grading comment
Thank you.
Notes to answerer
Asker: so that would mean that the reference that follows offers conclusive/decisive information


Peer comments on this answer (and responses from the answerer)
agree  texjax DDS PhD: Also "conclusive", I think
3 hrs
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