Hlášení a zprávy související s dokončením klinického hodnocení

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Title in English Notifications and reports associated with a clinical trial completion
Authors

KUBÁTOVÁ Jana

Year of publication 2023
Type Conference abstract
MU Faculty or unit

Faculty of Medicine

Citation
Description The lecture summarized notifications and reports required in association with the completion of the clinical trial, including the definition of deadlines. In view of the ongoing transitional period, it also compared the requirements of the "old" and "new" legislation, i.e. the obligations arising mainly from Decree No. 226/2008 Coll. on good clinical practice compared to the requirements arising from Regulation No. 536/2014 on clinical trials on medicinal products for Human use.
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