Standardy Klinického hodnocení Sample Clauses

Standardy Klinického hodnocení. Zdravotnické zařízení a Zkoušející provádějí Klinické hodnocení v souladu s (i) podmínkami této Smlouvy; (ii) Protokolem; (iii) odůvodněnými písemnými pokyny společnosti Idorsia; (iv) všeobecně přijímanými standardy dobré klinické praxe; (v) směrnicí pro dobrou klinickou praxi International Council on Harmonization of Technical Requirements of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (xxxx označovaná xxx xxxx „ICH- GCP“); a (vi) veškerými národními a mezinárodními právními předpisy, vyhláškami, pravidly a směrnicemi jakéhokoli státního úřadu (xxxx označovaný xxx xxxx „Regulační orgán“) a jakéhokoli jiného úřadu, které se vztahují na provádění Klinického hodnocení nebo na činnosti zamýšlené touto Smlouvou (xxxx označované xxx xxxx „Příslušné právní předpisy”).
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Standardy Klinického hodnocení. Zdravot- nické zařízení a Zkoušející provádějí Klinické hodnocení v souladu s (i) podmínkami této Smlouvy; (ii) Protokolem; (iii) odůvodněnými písemnými pokyny společnosti Idorsia; (iv) standards of good clinical practice; (v) the In- ternational Council on Harmonization of Technical Requirements of Pharmaceuticals for Human Use Guideline for Good Clinical Practice (“ICH-GCP”); and (vi) all national and international laws, ordinances, rules, and regulations of any governmental authority ("Regulatory Authority") and any other au- thority that apply to the conduct of the Study or the activities contemplated hereunder ("Applicable Law"). všeobecně přijímanými standardy dobré klin- ické praxe; (v) směrnicí pro dobrou klinickou praxi International Council on Harmonization of Technical Requirements of Pharmaceuti- cals for Human Use Guideline for Good Clin- ical Practice (xxxx označovaná xxx xxxx „ICH- GCP“); a (vi) veškerými národními a mezinárodními právními předpisy, vyhláškami, pravidly a směrnicemi jakéhokoli státního úřadu (xxxx označovaný xxx xxxx „Regulační orgán“) a jakéhokoli jiného úřadu, které se vztahují na provádění Klin- ického hodnocení nebo na činnosti zamýšlené touto Smlouvou (xxxx označo- vané xxx xxxx „Příslušné právní předpisy”).

Related to Standardy Klinického hodnocení

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