Conduct of Individual Studies Sample Clauses

Conduct of Individual Studies. 2. P rovádění jednotlivých studií Ethics Approval and Informed Consent. An Independent Ethics Committee or its local equivalent (“EC”), established and constituted in accordance with Applicable Law (defined below), approves and oversees the conduct of each Study. Institution will fulfil its obligations under applicable legislation,. Investigator shall obtain from each person enrolling in the Study, prior to the subject’s participation in the Study (a “Study Subject”), their consent to participate in the study on a valid written informed consent form (“ICF”) and document it as required by Applicable Law (defined below). The valid ICF shall be delivered to Investigator by Abbott. The ICF must permit Abbott and its representatives to access, process, obtain copies, transfer and retain Study data under applicable legal regulations. The Institution and the Investigator will comply with the terms of the consent, the Protocol, ▇▇▇▇▇▇’▇ instructions, and any guidance provided by the EC. EC will notify Abbott and the Institution immediately in case of Study approval withdrawal. Schválení etických komisí a informovaný souhlas Nezávislá etická komise (▇▇▇▇ ▇▇▇ „EK“), zřízená a ustanovená v souladu s platnými zákony (definovanými níže), schvaluje jednotlivé Studie a dohlíží na jejich provádění. Zdravotnické zařízení bude plnit své povinnosti v rámci platných právních předpisů. Zkoušející lékař ▇▇▇▇▇ ▇▇ každé osoby zařazené do Studie, před účastí subjektu ve studii (▇▇▇▇ ▇▇▇ „Studijní subjekt“) jeho souhlas s účastí ve studii na platném formuláři písemného informovaného souhlasu (▇▇▇▇ ▇▇▇ „ICF“) a zdokumentuje jej, jak vyžadují platné zákony (definované níže). Platný formulář ICF bude Zkoušejícímu lékaři dodán společností Abbott. ICF musí společnosti Abbott a jejím zástupcům povolit přístup, zpracování, získávání kopií, přenos a uchovávání studijních údajů v rámci platných právních předpisů. Zdravotnické zařízení a Zkoušející lékař budou dodržovat podmínky souhlasu, protokol, pokyny společnosti Abbott a jakékoli pokyny poskytnuté Evropskou komisí. V případě, že EK odejme schválení Studie, neprodleně o ▇▇▇ uvědomí společnost Abbott a Zdravotnické zařízení.
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  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement or the Prospectus, or the results of which are referred to in the Registration Statement or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMA, Health Canada and other comparable regulatory agencies outside of the U.S. to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, 312, and 812; the descriptions of the results of such studies, tests and trials contained in the Registration Statement or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Registration Statement or the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • Presentation of Potential Target Businesses The Company shall cause each of the Initial Shareholders to agree that, in order to minimize potential conflicts of interest which may arise from multiple affiliations, the Initial Shareholders will present to the Company for its consideration, prior to presentation to any other person or company, any suitable opportunity to acquire an operating business, until the earlier of the consummation by the Company of a Business Combination or the liquidation of the Company, subject to any pre-existing fiduciary obligations the Initial Shareholders might have.

  • Regulatory Matters and Approvals Each of the Parties will give any notices to, make any filings with, and use its reasonable best efforts to obtain any necessary authorizations, consents, and approvals of governments and governmental agencies in connection with the transactions contemplated by this Agreement. Without limiting the generality of the foregoing:

  • Environmental Studies Promptly conduct and complete, at Borrower’s expense, all such investigations, studies, samplings and testings as may be requested by Lender or any governmental authority relative to any substance, or any waste or by-product of any substance defined as toxic or a hazardous substance under applicable federal, state, or local law, rule, regulation, order or directive, at or affecting any property or any facility owned, leased or used by Borrower.