Požadavky Lékárny Sample Clauses

Požadavky Lékárny. Actelion je povinen provést iniciační návštěvu pověřeného farmaceuta příslušné lékárny FN Plzeň před zahájením příslušného klinického hodnocení. V rámci iniciační návštěvy musí být pověřenému farmaceutovi předány: - všechny nezbytné informace pro jeho/její účast v klinickém hodnocení -související dokumentace stanovená legislativou, Státním ústavem pro kontrolu léčiv nebo jinou regulační autoritou (zejména souhrn protokolu, study file, schválení SÚKL a etickou komisí atd.) -požadavky a pokyny týkající se vedení evidence - Delegation log, obsahující seznam všech osob oprávněných zacházet s hodnocenými léčivými přípravky, jehož případnou aktualizaci bude zadavatel následně Actelion notes that a consignment of Study Drug will not be accepted by the authorised pharmacist prior to carrying out the aforementioned initial visit. Actelion agrees to deliver the properly labelled consignments of Study Drug on working days between 8a.m. and 1p.m. solely upon prior agreement with the authorised pharmacist. Unless expressly agreed otherwise in writing by mutual agreement, the authorised pharmacist shall inform the Investigator upon confirming receipt of the delivery and shall hand over the Study Drug to the Institution as soon as possible. Until the Study Drug is handed over to the Institution, the authorised pharmacist is responsible for checking the handling of the Study Drug according to the principles of good medical practice and the instructions by Actelion, including relevant document management. 1.7.3
Sample 1
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