Phase IV Trial means a clinical trial of a pharmaceutical product initiated in a country in an approved indication after receipt of Regulatory Approval for such product in such indication in such country, intended to delineate additional information about such product’s risks, benefits and/or optimal use.

Phase IV Trial means a human clinical trial for a Collaboration Product Commenced after receipt of Regulatory Approval in the country for which such trial is being conducted and that is conducted within the parameters of the Regulatory Approval for the Collaboration Product. Phase IV Trials may include, without limitation, epidemiological studies, modeling and pharmacoeconomic studies of Collaboration Product and post-marketing surveillance studies.

Phase IV Trial means a clinical trial of a Product, including pharmacokinetic studies, which trial (a) is not required in order to obtain Regulatory Approval of an indication; and (b) either (i) is required by the Regulatory Authority as mandatory to be conducted on or after the Regulatory Approval of an indication, or (ii) is conducted voluntarily to enhance marketing or scientific knowledge of the product (e.g., providing additional drug profile, outcomes research, safety data or marketing support information, or supporting expansion of product labeling).

Examples of Phase IV Trial in a sentence

In a manner determined by the Operating Committee, the parties will coordinate on a local level the detailing, speaker/after-hours programs and, as appropriate, Phase IV Trial Activities in execution of the Annual Plan.
Licensee may make a written proposal to the CC regarding post-Regulatory Approval activities (including a Phase IV Trial) for the Licensed Product in the Field in the Territory.
Theratechnologies shall be responsible for all cost and expense related to additional Clinical Trials conducted in accordance with Section 3.3 and any Phase IV Trial and any other post-Marketing Approval study in Canada (including safety registries).
SA shall not have the right to conduct any research and development activities related to the Product, except with respect to: (i) Phase IV Trials required by the Regulatory Authority of a Country after Thera has approved the protocol related to such Phase IV Trial and (ii) the maintenance of any Long-Term Observational Studies required by the Regulatory Authority of a Country.
No royalties shall accrue on the disposition of Licensed Products in reasonable quantities by Zafgen, its Affiliates or Sublicensees as part of an expanded access program, a Phase IV Trial, or as donations to non-profit institutes, government agencies for non-commercial purposes, provided, in each case that either Zafgen, its Affiliates or Sublicensees supply such Licensed Product at or below cost.

More Definitions of Phase IV Trial

Phase IV Trial means clinical trial of a Product commenced in a particular country after Regulatory Approval for such Product in such country in order to (a) support Commercialization of the Product, or (b) fulfill a post-approval study commitment or undertaking imposed by the applicable Regulatory Authority in such country.

Phase IV Trial means (i) any clinical trial in humans conducted to satisfy a requirement of a Regulatory Authority in order to maintain a Regulatory Approval and (ii) any clinical trial in humans conducted after the first Regulatory Approval in the same disease state for which the Licensed Product received Regulatory Approval in the Territory.

Phase IV Trial means (a) a human clinical trial of a Licensed Product conducted following commencement of a pivotal clinical trial for such Licensed Product that is not required for receipt of Regulatory Approval (whether such clinical trial is conducted prior to or after receipt of such approval), but that may be useful in support of the post-approval exploitation of a Licensed Product; or (b) a human clinical trial of a Licensed Product conducted after Regulatory Approval of such Licensed Product has been obtained from an appropriate Regulatory Authority due to a request or requirement of such Regulatory Authority.

Phase IV Trial means a clinical trial of a pharmaceutical product initiated in a country in an approved indication after receipt of Regulatory Approval for such product in such indication in such country, to delineate additional information about such product’s risks, benefits and optimal use.

Phase IV Trial means a clinical trial of the Product or any Combination Product Commenced in a particular country after Health Registration Approval for such Product or Combination Product in such country in order to support Commercialization of the Product or Combination Product, as appropriate.