Global Studies definition

Global Studies means any human clinical trials of Licensed Product for the Initial Indication, other than bridging studies or similar studies that are conducted to show an equivalency to other clinical trials conducted in the Territory, designed to obtain information for purposes of seeking and obtaining both (a) Regulatory Approval for Licensed Product for the Initial Indication in the Territory and (b) approval of the relevant regulatory authorities to market Licensed Product for the Initial Indication in the European Union and/or Japan.
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Global Studies means more than one Global Study.
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Examples of Global Studies in a sentence

  • Four Requirements: Environmental, Ethnicity, Gender, & Global Studies Courses.

  • TAYLOR, “Intelligence-Sharing Agreements & International Data Protection: Avoiding a Global Surveillance State”, Washington University Global Studies Law Review 2018, vol.

  • In this illustrative example, the school-wide target is based on a 3% increase in students scoring at or above proficiency (score of 65) on each of the following Regents exams: English, Algebra I, Global Studies, U.S. History, and Living Environment Regents exams.

  • The programme is led by the School of Geography, Geology and the Environment, supported by the School of Life Sciences, with additional teaching by staff from the School of Chemical and Physical Sciences, the School of Social, Political and Global Studies, and other areas of the University.

  • Toulan School of Urban Studies and Planning (TSUSP), the Department of Economics, and the Department of International & Global Studies.

  • The JSC shall coordinate, liaise, review and discuss matters related to the Development of the Product in the Territory, the Reserved Territory and the Global Studies to be undertaken in accordance with this Agreement.

  • The Economics of Poverty Traps(University of Chicago Press & NBER), forthcoming.Barrett, C., M.R. Carter and P.D. Little (editors), Understanding and Reducing Persistent Poverty in Africa (Routledge), 2008.Carter, Michael, Fred Zimmerman and Jeffery Cason (editors) Development at a Cross- roads: Uncertain Paths to Sustainability after the Neo-Liberal Revolution (Madison, WI: Global Studies Research Program), 1998.Carter, Michael and Luis Galeano.

  • Courses for APPX Concentration Areas James Farmer Global Studies *Successful completion of the AP Capstone Diploma Program courses, AP Seminar and AP Research, is required to fulfill the C.L.A.S.S. requirement for the APPX distinction.

  • For Clinical Trials of a Product that may be used to support Regulatory Approval for such Product in the other Party’s territory (including Global Studies), such exchange shall also include all data, results and analyses as reasonably requested by a Party, and the other Party shall have the right to use such data and results for the purpose of obtaining and maintaining Regulatory Approval for the Product in its territory.

  • ARIAD US and ARIAD SWISSCO shall use good faith efforts to coordinate and liaise, through the JSC, concerning continued Development of the Product with respect to (i) Development being Global Studies, Ongoing Studies and Proposed Studies and (ii) each Party’s separate plans for Development in its respective territory.

Related to Global Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Clinical Trial means any human clinical trial of a Product.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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.

  • JDC has the meaning set forth in Section 3.2.

  • Development Plan has the meaning set forth in Section 3.2.

  • Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.

  • 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 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.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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 III Clinical Study means a trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • JPC means Joint Planning Committee.

  • 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).

  • DRS/Profile means the system for the uncertificated registration of ownership of securities pursuant to which ownership of ADSs is maintained on the books of the Depositary without the issuance of a physical certificate and transfer instructions may be given to allow for the automated transfer of ownership between the books of DTC and the Depositary. Ownership of ADSs held in DRS/Profile is evidenced by periodic statements issued by the Depositary to the Holders entitled thereto.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • 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.

  • JRC has the meaning set forth in Section 2.2.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • 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 I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • JSC has the meaning set forth in Section 3.1.