Validation Phase definition

Validation Phase is the first phase of the Project where the Owner and Risk/Reward Team members document the Base Program and establish the Target Cost and the Added Value Incentive Items.
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Validation Phase means that portion of the Work and the Services as described in Part C of this Agreement to be performed under this Agreement prior to the commencement of the Design and Procurement Phase as described in Section 10.10.
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Validation Phase means the first few phases of the Project (Conceptualization and
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Examples of Validation Phase in a sentence

  • Recommend disposition to the Joint Doctrine Planning Conference (JDPC) or staff a recommendation IAW out-of-cycle proposal procedures (see Validation Phase).

  • Two separate mechanisms, with different application requirements, have been set up to achieve these goals: Technology Validation (Phase 1) and Start-Up Fund (Phase 2).This RFP specifically covers Phase 2 – Start-Up Fund.

  • Beginning on the effective date of this ORDER, and for as long as this ORDER shall remain in effect, the Bank shall establish authority and controls over any information systems service provider(s) that the Bank may utilize sufficient to assure the effective and timely completion of all hardware and software testing that is needed to complete the Validation Phase of the Bank’s Year 2000 Plan as described above in Paragraph 2(e) of this ORDER.

  • The Validation Phase shall include user acceptance testing, system performance (stress) testing, and system parallel testing.

  • Demonstration and Validation Phase was renamed Program Definition and Risk Reduction.

  • Noble Resources International Pte Ltd, by being an Associate of Noble, is a substantial shareholder of the Company, the Company is required to seek Shareholder approval under ASX Listing Rule 10.1 in respect of entering into the security arrangements for the Facility Agreement.

  • If Owner expressly provides notice of its intent to suspend the Project, CM/GC and Architect shall promptly provide Owner with an estimate of any impact on: (i) during the Construction Phase, the Allowable Cost, Expected Cost, Target Cost and the EMP; or (ii) during the Validation Phase or the Design and Procurement Phase, the Allowable Cost, Expected Cost and Target Cost that will result from the suspension.

  • No Work or Services shall be performed in the Validation Phase or the Design and Procurement Phase except pursuant to a Work Authorization signed by each of the Owner, Architect and the CM/GC..

  • The Validation Phase includes the validation processing of the SIPs by the Archive and any necessary follow-up action with the Producer.

  • The Core Group will determine the frequency of work planning meetings during the Validation Phase and the Design and Procurement Phase and when weekly planning meetings will be initiated for the Project.


More Definitions of Validation Phase

Validation Phase is that portion of the Work and the Services to be performed under this Agreement up through Owner’s approval of the Validation Study.
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Validation Phase means the period of time commencing upon the conclusion of the Pilot Phase and continuing until the completion of the regulatory filing described in Section 4.5.
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Related to Validation Phase

  • Construction Phase means that Phase of the Project which shall commence after the Authority provides the Trade Contractor with written Notice to Proceed with the Construction Phase.

  • Development Phase means the period before a vehicle type is type approved.

  • Design Phase means the period during which the Transporter shall prepare a draft project proposal for publication in accordance with section 4.3;

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.

  • Phase 3 means the period commencing on the day after the Phase 2 implementation date and ending on the Phase 3 implementation date (as defined below).

  • Phase 2 means the second implementation phase of this section, beginning June 1, 2022 and continuing thereafter.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • Phase III means Phase I (or Phase I/II), Phase II (or Phase II/III) and Phase III clinical trials, respectively, in each case as prescribed by applicable FDA IND Regulations, or any corresponding foreign statutes, rules or regulations.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Study Completion means the database for the Study has been locked and all Essential Documents have been provided to the Sponsor, including a copy of the letter from the Reviewing HREC acknowledging receipt of the final report and/or closure letter from the Principal Investigator.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Construction Phase Services means the coordination, implementation and execution of the Work required by this Agreement, which are further defined in Article 8.

  • Acceptance Tests means those tests performed during the Performance Period which are intended to determine compliance of Equipment and Software with the specifications and all other Attachments incorporated herein by reference and to determine the reliability of the Equipment.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Acceptance Test is a test of the Features executed by the Customer to prepare the acceptance.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Stage 1 means the area at Port Xxxxxxx which is the subject of this Agreement and of the ERMP and which is shown bordered in purple as “stage 1” on Department of Land Administration 4 Miscellaneous Plan No. 1743;