Phase IV Clinical Trial definition

Phase IV Clinical Trial means a product support clinical trial of a Product that (a) is commenced after receipt of Regulatory Approval in the country where such trial is conducted and (b) that is not a Phase IIIb Clinical Trial. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, “post-marketing surveillance trials” and investigator-sponsored clinical trials studying a Product that are approved by the JDC and that otherwise fit the foregoing definition.
Phase IV Clinical Trial means a post-registrational Clinical Trial conducted in any country or countries and required as a condition to, or for the maintenance of, any Regulatory Approval for a Product in the Territory.
Phase IV Clinical Trial means clinical study of a pharmaceutical product on human subjects commenced after receipt of Regulatory Approval of such pharmaceutical product for the purpose of satisfying a condition imposed by a Regulatory Authority to obtain Regulatory Approval, or to support the marketing of such pharmaceutical product, and not for the purpose of obtaining initial Regulatory Approval of a pharmaceutical product.

Examples of Phase IV Clinical Trial in a sentence

  • Principal Investigator: Abbott Laboratory (Phase IV Clinical Trial) c) Validation of a Canadian Quality of Life Instrument for Childhood Epilepsy.

  • Routine Care During Clinical Trials We will pay for Covered Services that are Routine Patient Care Costs furnished to a Covered Person participating in a Phase I, Phase II, Phase Ill, or Phase IV Clinical Trial if the service, item or drug is otherwise covered under this Contract.

  • Phase IV Clinical Trial Notification with ATMP (post-marketing) Art.33 Post-marketing clinical trials (phase IV) with ATMP are subject to the reporting regimen without the need for DSCTA or DDCTA submission.

  • Collaboration Product in an indication, other than a Phase III Clinical Trial or Phase IV Clinical Trial, to be conducted after a Regulatory Approval for such indication.

  • Provided that where any Phase IV Clinical Trial is required by the FDA in the Territory after the NDA Approval Date, the Parties shall promptly agree in good faith the plans and protocols for such Additional Study and the Licensee shall be entitled to conduct the same as a Clinical Study, at its sole cost and expense.


More Definitions of Phase IV Clinical Trial

Phase IV Clinical Trial means any post-marketing trial, investigation or study conducted or required to be conducted to obtain additional safety and/or efficacy information about a product or compound in the indication for which Marketing Approval was issued.
Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for the purposes of conducting safety surveillance and ongoing technical support of the Product.
Phase IV Clinical Trial means any clinical trial in an indication to be conducted after a Regulatory Approval in such indication which was mandated by the applicable Regulatory Authority as a condition of such Regulatory Approval.
Phase IV Clinical Trial or “Post-Marketing Study” means a post-marketing human clinical trial for a Licensed Product commenced after receipt of a 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 Product. Phase IV Clinical Trials may include, without limitation, epidemiological studies, modeling and pharmacoeconomic studies, investigator-sponsored clinical trials of Product and post-marketing surveillance studies.
Phase IV Clinical Trial has the meaning contained in Title 21, Section 312.85 of the U.S. Code of Federal Regulations in the U.S., and analogous regulations in any legal jurisdiction other than the U.S.
Phase IV Clinical Trial means, for the purposes of this Agreement, any clinical trial initiated after regulatory approval to market a Licensed Product because completing that trial successfully was required by the regulatory agency as a condition of such approval. Also, Phase IV Clinical Trial includes trials intended to expand or alter the scope of the regulatory approval (a) to include additional or alternative dosing, or (b) to include additional or alternative routes of administration, or (c) to comply with new regulatory requirements. Clinical Trials for indications additional to those already approved are not Phase IV Clinical Trials.
Phase IV Clinical Trial means a Clinical Trial conducted after a Collaboration Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Collaboration Product.