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regulatory commitment

Dutch translation: om te voldoen aan de eisen van de regelgevende instanties

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)

English term or phrase:	regulatory commitment
Dutch translation:	om te voldoen aan de eisen van de regelgevende instanties

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14:31 Jan 4, 2012

The asker opted for community grading. The question was closed on 2012-01-08 13:54:09 based on peer agreement (or, if there were too few peer comments, asker preference.)

English to Dutch translations [PRO]
Medical - Medical (general) / study protocol

English term or phrase: regulatory commitment

This study is a regulatory commitment to collect post marketing authorization data within the approved indication.

Hermine M. Slootweg-Zaatman KudoZ activity Questions: 24 (none open) (4 without valid answers) Answers: 15
Local time: 15:55

om te voldoen aan de eisen van de regelgevende instanties

Explanation:
Dus: Dit onderzoek verzamelt..... om te voldoen aan de eisen van de regelgevende instanties.

Selected response from:

Catharina Adams
Local time: 15:55

Grading comment

Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer

Summary of answers provided
4 +5	om te voldoen aan de eisen van de regelgevende instanties	Catharina Adams
2	bij .. is er een overeenkomst met de regelgevende instantie(s) om	Barend van Zadelhoff

Answers

38 mins confidence:

peer agreement (net): +5

om te voldoen aan de eisen van de regelgevende instanties

Explanation:
Dus: Dit onderzoek verzamelt..... om te voldoen aan de eisen van de regelgevende instanties.

Catharina Adams
Local time: 15:55
Specializes in field
Native speaker of:

Dutch
PRO pts in category: 10

Grading comment

Selected automatically based on peer agreement.

Notes to answerer

Asker: thank you!

51 mins confidence:

bij .. is er een overeenkomst met de regelgevende instantie(s) om

Explanation:
my two cents

Bij dit onderzoek is er een overeenkomst met regelgevende instantie(s) om binnen de goedgekeurde indicatie gegevens te verzamelen na het afgeven van de vergunning voor het in de handel brengen

This is a regulatory commitment and represents an area of growing unmet need, and an opportunity to optimize the utility of CUBICIN in the infectious disease armamentarium

An additional post-approval regulatory commitment that we have with the FDA is a study of CUBICIN as part of combination therapy for infective endocarditis. Here we will compare safety and efficacy of CUBICIN at 6 mg/kg with and without gentamicin. We expect this exploratory Phase 2 study should begin enrollment in the first half of 2008.

http://www.wikinvest.com/stock/Cubist_Pharmaceuticals_(CBST)...

Barend van Zadelhoff
Netherlands
Local time: 15:55
Specializes in field
Native speaker of:

Dutch
PRO pts in category: 109

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regulatory commitment

Dutch translation: om te voldoen aan de eisen van de regelgevende instanties

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regulatory commitment

Dutch translation: om te voldoen aan de eisen van de regelgevende instanties

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KudoZ™ translation helpThe KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.

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The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.