Registration Trial definition
Registration Trial means a human clinical trial anywhere in the world that is a clinical trial or study that intends to provide the ultimate evidence and data that a Regulatory Authority uses to decide whether or not to approve a potential new medicine. For clarity, a Phase 2 or 2(b) Clinical Trial that satisfies the requirements of 21 CFR §312.21 (c) or its equivalent prescribed by the Regulatory Authority in the applicable country or regulatory jurisdiction other than the United States where the clinical trial takes place shall be considered a Registration Trial.
Registration Trial means the first clinical trial which is designed to support Regulatory Approval for the Product in a country or Region. Notwithstanding, any Phase III Clinical Trial shall be deemed a Registration Trial.
Registration Trial means [***]. A Registration Trial may require only a portion of, but not necessarily the entirety of, [***].
Examples of Registration Trial in a sentence
If a Clinical Trial does not meet the requirements of a Registration Trial at the time of the dosing of the first subject, but is later re-designed or otherwise converted into a Clinical Trial that meets the requirements of a Registration Trial, then, such Clinical Trial shall be deemed a Registration Trial, and the milestone event in Section 9.4(a) shall be deemed achieved, as of the date of such re-design or conversion.
More Definitions of Registration Trial
Registration Trial means the clinical trial activity required by a governmental regulatory authority to be completed as a prerequisite to the sale of a Product within the regulatory authority’s jurisdiction. Clinical trial activity intended solely to ▇▇▇▇▇▇ customer acceptance (i.e., a “market trial”), rather than intended to generate approval by a regulatory authority, shall not be considered a Registration Trial.
Registration Trial means a human clinical trial (whether or not designated a Phase 3 Trial) of a Licensed Product that is designed to ascertain efficacy and safety of such Licensed Product for the purpose of submitting a Drug Approval Application to the competent Regulatory Authorities; provided that any clinical trial that would not otherwise constitute a Phase 3 Trial shall constitute a Registration Trial if acknowledged as such in writing by the FDA (or using such other method of acknowledgement as may be used in the future by the FDA).
Registration Trial means, with respect to any Licensed Product, a controlled human clinical trial that is expected by Licensee to be the basis for filing an application for regulatory approval of such Licensed Product.
Registration Trial means, with respect to a Product, a Clinical Trial that is expected to provide data necessary for the preparation and submission of a MAA or BLA to obtain Regulatory Approval of such Product in a country in the Territory as evidenced by (a) GSK’s or its Affiliate’s designation of such Clinical Trial as a Phase 3 Clinical Trial in the protocol or otherwise as a Clinical Trial on which an MAA or BLA will be based or (b) an agreement or other statement or guidance from the Regulatory Authority in such country that such Clinical Trial is designed to provide data on which an MAA or BLA will be based. For purposes of Article 8, if a Clinical Trial becomes a Registration Trial after the initiation thereof, the applicable milestone event shall be deemed to occur on the first date that GSK receives evidence described in the prior sentence, and in any case, no later than the filing of a MAA or BLA with respect to such Product.
Registration Trial means (a) with respect to a Product, a clinical study of such Product in human patients (i) with a defined dose or a set of defined doses of such Product designed to establish statistically significant efficacy and safety of such Product for the purpose of enabling the preparation and submission of an MAA for such Product to the competent Regulatory Authorities in a country or other jurisdiction, and (ii) that would satisfy the requirements of 21 C.F.R. § 312.21(c), or its foreign equivalent, and (b) with respect to the Optejet Dispenser Base, a clinical study of such medical device in human subjects that would satisfy the IDE requirements set forth in 21 C.F.R. Part 812, or its foreign equivalent.
Registration Trial means the pivotal safety and efficacy studies used by the appropriate governmental entity to determine whether or not to approve an investigational drug, for example by the Food and Drug Administration as set forth in 21 C.F.R §314
Registration Trial means a Phase III study, a combined Phase II/Phase III study, or any Phase II study in lieu of a Phase III study), or any well controlled study intended to provide the substantial evidence of efficacy necessary to support an NDA Filing (a “Pivotal Study”).