Clinical Investigator Brochure Soubor informací Sample Clauses

Clinical Investigator Brochure Soubor informací pro zkoušejícího A brochure provided by Sponsor that contains a set of clinical and non-clinical data on the Investigational Product(s) which are important for clinical trials performed on the Qualified Participants and that contains summary information of all studies carried out during the development of the Investigational Product Soubor informací poskytovaný Zadavatelem, který obsahuje souhrnné klinické a neklinické údaje o Hodnoceném léčivu(ech), které se vztahují ke klinickému hodnocení na lidských subjektech a obsahující informace o všech klinických hodnoceních uskutečněných během vývoje Hodnoceného léčiva.
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Clinical Investigator Brochure Soubor informací pro zkoušejícího A brochure provided by the Sponsor that contains a set of clinical and non-clinical data on the Investigational Product(s) which are important for clinical trials performed on the Qualified Participants and that contains summary information of those studies carried out on the Investigational Product that are relevant to the Study and meeting the requirements of applicable Regulations. Soubor informací poskytovaný zadavatelem, který obsahuje souhrnné klinické a neklinické údaje o hodnoceném léčivu(ech), které se vztahují ke klinickému hodnocení na způsobilých subjektech a obsahují informace o těchto klinických hodnoceních uskutečněných s hodnoceným léčivem, jež souvisejí s klinickým hodnocením a splňují požadavky platných právních předpisů.

Related to Clinical Investigator Brochure Soubor informací

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