Phase 2 Package definition

Phase 2 Package means, with respect to any Phase 2 Clinical Trial, (a) the final study report from such Phase 2 Clinical Trial, including completed case report forms, as and to the extent available, for all patients who participated in the Phase 2 Clinical Trial, and (b) the status of and reasonable access to available results and data of all ongoing studies (including preclinical and clinical) with respect to the Product. For purposes of this definition, the study report shall be deemed “final” at such time as such report is in the form that will be filed with the FDA.
Sample 1

Examples of Phase 2 Package in a sentence

  • The Project is part of an overall plan approved under a statutory EIA for Outlying Islands Sewerage Stage 1 Phase 2 Package J – Sok Kwu Wan Sewage Collection and Treatment (Register No. AEIAR-075/2003) and Disposal Facilities and Outlying Islands Sewerage Stage 1 Phase 1 Package C – Yung Shue Wan Sewage Treatment Works and Outfall (Register No. EIA-124/BC).

  • MWAA is planning an all-electronic distribution of plans, but is not quite there yet; hard copies are still being sent to some of the reviewers.MWAA accepted HPCC’s request to use Prolog for their comment management system for design and submittal review in lieu of the electronic comment management system currently being used by MWAA on Phase 2, Package A (LATISTA).

  • It is why I recently fought to secure $7 mil- lion for the creation of the Korean American National Museum, the first museum in the na- tion dedicated to honoring over a century of Korean American history and culture.

  • RMC’s 53 wards have been divided into 59 water supply zones (based on hydraulic design requirements) and this project is a part of the proposed Phase 2 Package - C which intends to augment availability of treated water for the Ranchi Water Supply System (RWSS).

  • Mature judgment, extraordinary discretion and thoughtful decisiveness to perceive the critical impact and subtle implications of issues, make sound and timely recommendations and decisions, and serve as a trusted advisor to the Project Director, Metrorail Phase 2 Package A.

  • Capital Rail Constructors had presented its quarterly update for Phase 2, Package A of the Dulles Corridor Metrorail Project.

  • The first, and largest, procurement for design and construction of Phase 2, Package A, has been awarded by THE AIRPORTS AUTHORITY with a Notice to Proceed date of July 8, 2013.

  • In this regard, the Package A Pre-Solicitation Paper proposes that the performance bond required for the Phase 2 Package A design-build procurement be less than 100 percent of the design-build contract value.

  • Additionally, Hensel Phelps had presented a quarterly update on the Washington Metropolitan Area Transit Authority rail yard and maintenance facility - Phase 2, Package B.On July 19, the Committee had concurred with the pre-solicitation terms for a claims consultant to provide services for the Project.

  • Offeror is one of the design-builders prequalified to submit Proposals for the Dulles Corridor Metrorail Project, Phase 2, Package A (the “Project”), and wishes to submit a Proposal in response to the Request for Proposals for Package A (the “RFP”) issued by the Airports Authority.

Related to Phase 2 Package

  • Work package means a major sub-division of the proposed project.

  • Data Package has the meaning set forth in Section 2.9(a).

  • Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).

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

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase III means human clinical trials, the principal purpose of which is to establish substantial evidence of both safety and efficacy in patients with the disease or condition being studied, as more fully defined in 21 C.F.R. §312.21(c) or similar clinical study in a country other than the United States. Phase III shall also include any other human clinical trial intended to serve as a pivotal trial to support the submission of an application for regulatory approval.

  • Design Criteria Package means concise, performance-oriented drawings or specifications for a public construction project. The purpose of the Design Criteria Package is to furnish sufficient information to permit Design-Build Firms to prepare a bid or a response to the District’s Request for Proposals, or to permit the District to enter into a negotiated Design- Build Contract. The Design Criteria Package must specify performance- based criteria for the public construction project, including the legal description of the site, survey information concerning the site, interior space requirements, material quality standards, schematic layouts and conceptual design criteria of the project, cost or budget estimates, design and construction schedules, site development requirements, provisions for utilities, stormwater retention and disposal, and parking requirements applicable to the project. Design Criteria Packages shall require firms to submit information regarding the qualifications, availability, and past work of the firms, including the partners and members thereof.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • 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).

  • 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 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 I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

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

  • 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 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 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).

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • 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.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • 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 III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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.

  • Review Package A package of documents consisting of a memorandum outlining the analysis and recommendation (in accordance with the Servicing Standard) of the Master Servicer or the Special Servicer, as the case may be, with respect to the matters that are the subject thereof, and copies of all relevant documentation.

  • Phase II means the second part of the tuition incentive assistance program which provides assistance in the third and fourth year of 4-year degree programs.