Core Studies definition

Core Studies means nonclinical studies and those clinical studies necessary for; obtaining and maintaining regulatory approval of the Product and/or Device; maintaining the approved label on the Product; [*] improved needle and needle-free injection devices; including those studies related to safety, antibodies, QCT and any post-approval studies required by the U.S. Food and Drug Administration or EMEA and those described in Schedule 1.9. [*].
View Source
Core Studies has the meaning set forth in Section 4.1.
View Source

Examples of Core Studies in a sentence

  • The initial decision on appointment of a faculty member in the Institute of Core Studies shall be made in accordance with Article 8 of the Statutes of the University.

  • The President, ▇▇▇▇▇▇▇ or Director of the Institute of Core Studies shall make recommendations for initial full- time appointments to the instructional staff of the Institute.

  • The normal teaching load for faculty members in College of Professional Studies is twelve (12) credits per semester, except faculty members with the rank of Full Professor and at least twenty five years of full-time faculty service in the College of Professional Studies whose normal teaching load shall be nine (9) credits, and the normal teaching load for Institute for Core Studies is twelve (12) credits per semester.

  • The President, ▇▇▇▇▇▇▇ and Director of the Institute of Core Studies shall make recommendations for initial full- time appointments to the instructional staff of the Institute.

  • The President, ▇▇▇▇▇▇▇ or Director of the Institute of Core Studies shall make recommendations for initial full-time appointments to the instructional staff of the Institute.

  • Faculty Members The initial decision on appointment of a faculty member in the Institute of Core Studies shall be made in accordance with Article 8 of the Statutes of the University.

  • In the event any clinical trial(s) is required for Norgine to obtain any pricing and reimbursement approvals in addition to the Core Studies, then such additional clinical trial(s) shall be deemed Norgine Independent Studies.

  • The Parties are jointly responsible for the manufacturing of the Product for use in the Core Studies.

  • Each Party shall promptly provide the other Party with copies of final reports and of all Information (including preclinical and clinical data) generated in conducting the Core Studies.

  • Tranzyme shall not give such a notice to Norgine prior to completion of the Core Studies Development Plan except for a reasonable and material reason.

Related to Core Studies

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

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • 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 I Study means a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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.