Phase 3 definition
Phase 3 means a controlled or uncontrolled human clinical trial of a compound or product that would satisfy the requirements of 21 CFR 312.21(c) or its foreign equivalents.
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 3 shall have the meaning set forth in Section 1.4.
Examples of Phase 3 in a sentence
Description Fees Phase 1: Project Start-Up $44,130 Phase 2: Visioning and Gathering Input $177,040 Phase 3: Development of Draft General Plan $151,155 Phase 4: Presentation of Final Draft for Adoption $32,810 Project Total $405,135 Fees are inclusive of all services described in the Scope of Services.
This phase will span nearly half the planning process and overlap with Phase 3 Drafting of the Plan.
The Owner shall proceed with the installation or construction of the Works in Phase 2 within one (1) year of the date of the Final Certificate of Completion of Services in Phase 1, and shall commence construction of Primary Services on Phase 3 within one (1) year of Final Certification of Completion of Services in Phase 2.
The focus of this document will be a succinct list of key findings, and it will be used to confirm our understanding of the County’s current state with the County’s project team and as the basis for recommendations development in Phase 3.
Following the close of Phase 3 above and extending until two (2) weeks before the first student attendance day, the District may fill vacancies from both current employees still waiting to be placed and external candidates, subject to the “match” criteria and the following.
More Definitions of Phase 3
Phase 3 means a human clinical trial of a Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a or Licensed Product is safe and efficacious For its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
Phase 3 means the third phase of Stage 3 of the CFO Evolution progression route. “Pre-Release Inventory” means a document used to list support required for a programme Service User on release “Pre-Release Inventory Referral” means the referral to the Supplier team within the community to action the Pre-Release Inventory prior to the Service Users’ release. “Pre-Release Support” means support provided to the Service User prior to release from custody. “Prison Education Framework/Service” means educational services provided to individuals in custody. "Prison Offender Management Team” means the HMPPS prison-based team responsible for the management of offenders in custody. “Probation” means the statutory criminal justice service responsible for the supervision of offenders in the community. "Probation Delivery Unit" or "PDU" means an area with a defined geographical boundary within a PS Region, where Probation services are delivered. These areas were formally known as Local Delivery Unit (LDUs). “Probation Practitioner(s)” means professionals working in the Probation service. "Probation Service Region" or “PS Region” means an area with a defined geographical boundary, within which Probation services are delivered. Probation services are delivered across one or more PDU, which collectively make-up a PS Region. “Problem-Solving Court (PSC)” means an alternative to traditional methods of case management in criminal and civil courts. “Provider Guidance” means the suite of documentation issued by the Authority to the Supplier to provide additional context and procedures relating to delivery of services "Required Volume” means the required volume of output that the Supplier is required to provide per month for each element of the Services Levels and as set out in Schedule 2.2 (Call-Off Performance Levels) “Satellite Hub” means a CFO Activity Hub not deemed to be a main CFO Activity Hub in which the Services outlined under this Call-Off Contract are provided. “Stage 1” means the first stage of the CFO Evolution progression route – Reception & Assessment as described in Paragraph 9 of Schedule 2.1. “Stage 2” means the second stage of the CFO Evolution progression route – Preparation for entering the core programme as described in Paragraphs 10 and 11 of Schedule 2.1. “Stage 3” means the third stage of the CFO Evolution progression route - CFO Wing residence as described in Paragraphs 12 to 14 (inclusive) of Schedule 2.1. “Stage 4” means the fourth stage of the CFO Evolution ...
Phase 3 means a human clinical trial of a Licensed Compound or Licensed Product on a sufficient number of subjects in an indicated patient population that is designed to establish that a Licensed Compound or Licensed Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Licensed Compound or Licensed Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
Phase 3 means a human clinical trial of a Licensed Compound on a sufficient number of subjects that is designed to establish that a 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 marketing approval of such Licensed Compound, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
Phase 3 means the period for the plant construction and initial operation for the manufacture of the LICENSED PRODUCT.
Phase 3 means a human clinical trial of a Molecule or Product on a sufficient number of subjects in an indicated patient population that is designed to establish that such Molecule or Product is safe and efficacious for its intended use and to determine the benefit/risk relationship, warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support marketing approval of such Molecule or Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, including the trials referred to in 21 C.F.R. §312.21(c), as amended.
Phase 3 means that portion of the drug development and review process in which expanded clinical studies are conducted to gather the additional information to establish the effectiveness and safety that is needed to satisfy the requirements of a pivotal trial for obtaining regulatory approval to market an investigational new drug, as more specifically defined by the rules and regulations of the FDA or a similar regulatory requirement in any national jurisdiction.