Phase 4 Clinical Trial definition

Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

Phase 4 Clinical Trial means a product support clinical trial of a Product that is commenced after receipt of MAA Approval in the country where such trial is conducted. Phase 4 Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies and post-marketing surveillance trials.

Phase 4 Clinical Trial means a Clinical Trial of a Product that (a) is not required for receipt of Regulatory Approval for a country but which may be useful in providing additional drug profile data in support of such Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval), or (b) is required, requested or advised by a Regulatory Authority as a condition of, or in connection with, obtaining or maintaining Regulatory Approval (whether the trial is commenced prior to or after receipt of such Regulatory Approval). Phase 4 Clinical Trials may include trials or studies conducted in support of pricing/reimbursement approval, epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored Clinical Trials and health economics studies.

Examples of Phase 4 Clinical Trial in a sentence

• Phase IV CTRA: For post marketing surveillance Phase IV studies the “Clinical Trial Research Agreement- Phase 4 Clinical Trial (Medicines)” should be used.

• The “Clinical Trial Research Agreement Phase 4 Clinical Trial (Medicines)” should be used for post marketing surveillance Phase IV studies.

• Phase IV CTRA:For post marketing surveillance Phase IV studies the “Clinical Trial Research Agreement- Phase 4 Clinical Trial (Medicines)” should be used.

• After the first Regulatory Approval for a Licensed Product in the Field in the European Union is obtained by KHK, any such Development will be performed by the Parties as determined by the JSC, subject to Sections 3.1.3(b) and 4.2.2. Medgenics will take the lead for any Phase 4 Clinical Trial, and will provide assistance with respect to any other activity, that is required by the applicable Regulatory Authority to be conducted in the Territory and/or European Union for the initial indication in the Field.

• If Alpharma performs any Phase 4 Clinical Trial or other Clinical Trial of the Product in Subterritory A and the Major Market Jurisdictions following receipt of Regulatory Approval for the Product (each, a “Alpharma Post-Registration Study”), Alpharma shall provide Durect with draft forms of summary protocols for major studies before commencement of any such study.

More Definitions of Phase 4 Clinical Trial

Phase 4 Clinical Trial means a human clinical trial of a Product commenced after receipt of Regulatory Approval of the Product not for the purpose of satisfying a condition imposed by a Regulatory Authority to obtain Regulatory Approval, but only to support the marketing of such Product.

Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

Phase 4 Clinical Trial means a post-registration clinical trial or post-marketing surveillance study performed in accordance with Applicable Laws and required as a condition to, or for the maintenance of, any Regulatory Approval or pricing and/or reimbursement approval for a Licensed Product.

Phase 4 Clinical Trial means a post-registration clinical trial or post-marketing surveillance study performed in accordance with Applicable Laws and required as a condition to, or for the maintenance of, any Marketing Approval or Pricing and/or Reimbursement Approval for a Licensed Product.

Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority in the Territory, which trial is conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product. For clarity, Phase 4 Clinical Trials do not include Mandatory Post-Approval Safety Studies.

Phase 4 Clinical Trial means any post-marketing approval clinical study, whether initiated by a Party or at the request of any Governmental Authority, to delineate additional information about the Product’s risks, benefits, and optimal use.

Phase 4 Clinical Trial means, with respect to a Licensed Product for a given indication in a given country or jurisdiction, a clinical trial of such Licensed Product for such indication Initiated after receipt of Regulatory Approval for the sale of such product for such indication in such country or jurisdiction. Phase 4 Clinical Trials may include epidemiological studies, modeling and pharmacoeconomic studies, and post-marketing surveillance studies, as well as any clinical study or research study sponsored and conducted by an individual not employed by or on behalf of either Party.