Bridging Strategy definition

Bridging Strategy means the decision by Astellas to file an MAA in the Astellas Territory by submitting the data from the Phase III clinical trial of FG or its Affiliate or Sublicensee.
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Bridging Strategy means a development strategy for a new drug application that utilizes the Laxdale Approved Registration Dossier (as after defined) and the Laxdale Know-How, and if needed, in which only a bridging study is conducted to extrapolate the efficacy data and/or safety data in the Laxdale Approved Registration Dossier to the Territory;
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Bridging Strategy means the strategy for submission of a New Drug Application to the Regulatory Authority in Japan that involves use of results from Clinical Studies conducted outside Japan as indicated in ICH-E5.
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Examples of Bridging Strategy in a sentence

  • Upon the first [ * ] in the Astellas Territory for the [ * ]; provided, that in the event Astellas chooses the Bridging Strategy, such payment shall be increased by an additional U.S. $[ * ] for a total of U.S. $[ * ].

  • Our Bridging Strategy recognises the challenges faced by students transitioning from Level 3-4 and aims to support all students whether they are progressing internally, or externally.

  • Our Bridging Strategy and annual Employability Conference will further support this targeted demographic.

  • We have recently developed a Bridging Strategy (for full implementation 2018-19) which although aimed at our wider student demographic (by supporting all students transitioning from Level 3-4; 4-5; 5-6), has been devised (where appropriate) with some of our under-represented groups in mind (e.g. Mature students).

  • If the Japanese Regulatory Authority accepts the Bridging Strategy and SKK decides to employ the Bridging Strategy, SKK shall so notify Can-F▇▇▇ in writing and shall reimburse Can-F▇▇▇ for thirty percent (30%) of the Clinical Study Costs of Can-F▇▇▇’▇ Phase III Clinical Trial performed by Can-F▇▇▇ for the purpose of Can-F▇▇▇’▇ filing a New Drug Application in the United States for marketing the Product for rheumatoid arthritis.

  • Although our Bridging Strategy is aimed at our wider student demographic, specific workshops and activities including extra Study Skills sessions and ‘Refresher’ workshops on using Microsoft applications, e-resources and databases have been created partly with the mature, returning student in mind.

  • Upon the first [ * ] in the Astellas Territory for the first indication within [ * ] (see Exhibit B); provided, that in the event Astellas chooses the Bridging Strategy, such payment shall be increased by an additional U.S. $[ * ] for a total of U.S. $[ * ].

  • Notwithstanding anything to the contrary herein, SKK shall have the sole and exclusive discretion and decision-making authority to determine whether or not to employ the Bridging Strategy in the development of the Product in the Field in the Territory and, if SKK determines that the Bridging Strategy will be employed, SKK shall have the exclusive right to conduct such Bridging Strategy in the Field in the Territory using the Data disclosed by Can-F▇▇▇ hereunder.

  • Our Bridging Strategy (for first implementation 2018-19) which although aimed at our wider student demographic (by supporting all students transitioning from Level 3-4; 4- 5; 5-6), has been devised (where appropriate) with some of our under-represented groups in mind (e.g. Mature students).

  • Our Bridging Strategy recognises the challenges faced by students transitioning from Level 4-5 and 5-6.

Related to Bridging Strategy

  • Leader means each elected or appointed member of an AMA Council, AMA Committee, AMA Advisory Committee, or Task Force, members of the AMA Alliance board, members of the AMA Foundation board, and each candidate for an AMA Council, Section Governing Council or Advisory Committee, and other designated AMA committee and task force members and candidates.

  • Strategy means the Department of Education International Risk Management Strategy for Homestays and Short Term Cultural Exchanges developed and implemented under section 171 of the Working With Children (Risk Management and Screening) Act 2000 as in force at any given time.

  • Conference bridging service means an ancillary service that links two or more participants of an audio or video conference call and may include the provision of a telephone number. Conference bridging service does not include the telecommunications services used to reach the conference bridge.

  • Level 3 Support means, with the use of backup engineering and technical support staff, isolating Defects and developing Defect corrections including, without limitation, Upgrades.

  • spatial development framework means the Mhlontlo Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;