Pediatric Studies definition

Pediatric Studies or ‘studies’ means at least one clinical
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Pediatric Studies has the meaning set forth in Section 4.2(b).
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Pediatric Studies means any studies for the Vabomere Product or the Orbactiv Product required by both the European Pediatric Investigational Plan (PIP) and the U.S. Pediatric Study Plan (PSP).
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Examples of Pediatric Studies in a sentence

  • The Parties shall conduct the FDA CVOT Study and the FDA Pediatric Studies as provided in Section 3.2(a).

  • A list of the U.S. Studies and Pediatric Studies is set forth on Schedule 4.4(b).

  • AMAG shall use Commercially Reasonable Efforts to timely conduct all Development activities for the U.S. Studies and Pediatric Studies as set forth in the then-current Development Plan.

  • For the avoidance of doubt, Takeda shall have the right to use data and all other Information from the U.S. Studies and the Pediatric Studies included in the AMAG Technology for the purposes of obtaining and maintaining Regulatory Approval for the Product in the Licensed Territory in accordance with the terms of this Agreement.

  • As provided in Section 3.2(c), AMAG shall notify the JDC of its intent to conduct any studies of the Product (other than the Initial Studies, Future Required Studies, U.S. Studies or Pediatric Studies) that AMAG intends to use in obtaining or maintaining Regulatory Approval outside the Licensed Territory in the Field and under which AMAG may xxxxx Xxxxxx rights (the “Other AMAG Studies”), at the first JDC meeting following AMAG’s decision to conduct such studies.

  • In any event, Company shall submit to the JDC a proposal to collaborate with Licensee on the Pediatric Studies within ninety (90) days from the Effective Date.

  • Shared Study" means any of the Existing Studies (including Allos Studies and Pediatric Studies), EMA Approval Additional Studies or Additional Studies.

Related to Pediatric Studies

  • Study means the investigation to be conducted in accordance with the Protocol.

  • 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.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • 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.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Phase III Clinical Trial means a pivotal human clinical trial in any country the results of which could be used to establish safety and efficacy of a Product as a basis for a marketing application that would satisfy the requirements of 21 CFR 312.21(c).

  • 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.

  • Health screening means the use of one or more diagnostic tools to test a person for the presence or precursors of a particular disease.

  • 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).