Regulatory Compliance of Study 1 Sample Clauses

Regulatory Compliance of Study 1. 2 Vyhovění Studie regulačním požadavkům
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Regulatory Compliance of Study 1. 2 Vyhovění Studie regulačním požadavkům The Institution and the Investigator agree to conduct and to ensure that all Study Personnel conduct the Study in strict compliance with: (i) all applicable laws and regulations applicable to the conduct of clinical trials, including without limitation Act Xx. 000/0000 Xxxx., xx Xxxxx, Xxx No. 372/2011 Coll., on Medical Services and Regulation No. 226/2008 Coll., specifying the good clinical practice and stipulating the detailed conditions of the clinical assessment of therapeutic agents, (ii) all generally accepted standards of good clinical practice, including without limitation the current Good Clinical Practices Guidelines of the International Conference on Harmonization and the EU Clinical Trial Directive 2001/20/EC, (iii) the laws related to data protection and data privacy, including without limitation Data Protection Directive 95/46/EC and Act No. 101/2000 Coll., on Data Protection, and (iv) any other applicable law, rules, regulations and guidances (collectively, the “Applicable Regulatory Requirements”). The Institution and the Investigator shall also ensure that all Study Personnel are trained in good clinical practice and all aspects of the Protocol. Zdravotnické zařízení a Hlavní zkoušející souhlasí, že provedou a zajistí, aby Studijní personál provedl Studii ve striktní shodě se: (i) všemi zákony a předpisy platnými pro provádění klinického hodnocení včetně zákona č. 378/2007 Sb. o léčivech, zákona č. 372/2011 Sb., o zdravotních službách a vyhlášky č. 226/2008 Sb. o správné klinické praxi a bližších podmínkách klinického hodnocení (ii) všemi obecně přijímanými standardy správné klinické praxe včetně (mimo jiné) aktuálně Platných postupů Správné klinické praxe z Mezinárodní konference pro harmonizaci a směrnice EU pro klinická hodnocení 2001/20/EC, (iii) zákony týkajícími se ochrany údajů a soukromí údajů včetně Směrnice o ochraně dat 95/46/EK a zákona č. 101/2000 Sb. o ochraně osobních údajů, and (iv) všemi dalšími platnými zákony, předpisy, pravidly a pokyny (souhrnně „Platné regulační požadavky“). Hlavní zkoušející rovněž zajistí, aby byli všichni členové Studijního personálu vyškoleni ve správné klinické praxi a ve všech aspektech Protokolu.
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Regulatory Compliance of Study 1. 2 Zhoda Štúdie s právnymi predpismi The Institution agree to ensure that the Study is conducted in strict compliance with: (i) all applicable laws and regulations applicable to the conduct of clinical trials, including without limitation Act. No. 362/2011 Coll. on Drugs and Medical Devices and Act. No. 576/2004 Coll., on Health Care and Services related to the provision of Health Care, (ii) all generally accepted standards of good clinical practice, including without limitation the current Good Clinical Practices Guidelines of the International Conference on Harmonization, (iii) the EU Clinical Trial Directive 2001/20/EC, and the relevant regulations of the U.S. Food and Drug Administration and (iv) the laws related to data protection and data privacy, including without limitation the Data Protection Directive 95/46/EC and with the Act No. 122/2013Coll. on Personal Data Protection, (v) any other applicable law and regulations (collectively, the “Applicable Regulatory Requirements”). Inštitúcia súhlasí, že zabezpečí, aby sa Štúdia zrealizovala v prísnej zhode so (i) všetkými použiteľnými zákonmi a predpismi vzťahujúcimi sa na vykonávanie klinických skúšaní, okrem iného aj so zákonom č. 362/2011 Z. z. o liekoch a zdravotníckych pomôckach a zákonom č. 576/2004 Z. z. o zdravotnej starostlivosti a službách súvisiacich s poskytovaním zdravotnej starostlivosti, (ii) všetkými schválenými normami správnej klinickej praxe, okrem iného aj aktuálnymi usmerneniami Medzinárodnej konferencie o harmonizácii, ktoré sa týkajú správnej klinickej praxe, (iii) smernicou EÚ č. 2001/20/ES o klinickom skúšaní a príslušnými predpismi amerického Úradu pre potraviny a lieky, (iv) zákonmi o ochrane a utajovaní údajov, okrem iného aj smernicou 95/46/ES o ochrane osobných údajov a so zákonom č. 122/2013Z. z. o ochrane osobných údajov a (v) inými použiteľnými zákonmi a predpismi (spoločne „Platné právne predpisy“).
Sample 1
Regulatory Compliance of Study 1. 2. Soulad studie s požadavky kontrolních úšadn
Sample 1

Related to Regulatory Compliance of Study 1

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  • Statutory and Regulatory Compliance Contractor shall comply with all laws and regulations applicable to the Community Development Block Grant-Disaster Recovery funds appropriated by the Disaster Relief Appropriations Act, 2013 (Pub. L. 113-2), including but not limited to the applicable Office of Management and Budget Circulars, which may impact the administration of funds and/or set forth certain cost principles, including the allowability of certain expenses.

  • Program Compliance The School Board shall be responsible for monitoring the program to provide technical assistance and to ensure program compliance.

  • Regulatory Filing In the event that this Interconnection Construction Service Agreement contains any terms that deviate materially from the form included in Attachment P or from the standard terms and conditions in this Appendix 2, the Transmission Provider shall file the executed Interconnection Construction Service Agreement on behalf of itself and the Interconnected Transmission Owner with FERC as a service schedule under the Tariff. Interconnection Customer may request that any information so provided be subject to the confidentiality provisions of Section 17 of this Appendix

  • CEQA Compliance The District has complied with all assessment requirements imposed upon it by the California Environmental Quality Act (Public Resource Code Section 21000 et seq. (“CEQA”) in connection with the Project, and no further environmental review of the Project is necessary pursuant to CEQA before the construction of the Project may commence.

  • License Compliance HP may audit Customer compliance with the software license terms. Upon reasonable notice, HP may conduct an audit during normal business hours (with the auditor’s costs being at HP’s expense). If an audit reveals underpayments then Customer will pay to HP such underpayments. If underpayments discovered exceed five (5) percent of the contract price, Customer will reimburse HP for the auditor costs.

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