Definition of Post-Approval Study


Post-Approval Study means a clinical study of a Licensed Product initiated in a country after receipt of Regulatory Approval for such Licensed Product in such country.
Sample 1 Sample 2 Sample 3

Examples of Post-Approval Study in a sentence

In addition, Dermira shall be responsible for seeking required Review Board approvals of any Phase 3 Study or any Post-Approval Study, each in the Development Indication.
All Product and Comparator Drugs and Placebo supplied to Investigators or Institutions shall remain the exclusive property of UCB unless and until administered or dispensed to subjects during a Phase 3 Study, or a Post-Approval Study in the Development Indication in relation to the Development of the Product in the Development Indication in the Development Territory.
Dermira shall be responsible for all communications with the Investigators with respect to a Phase 3 Study, and any Post-Approval Study in relation to the Development of the Product in the Development Indication in the Development Territory.
Subject to the terms and conditions of this Agreement, UCB (or its designee) shall supply, in a timely manner in quantities and timing as agreed by the JDT to satisfy the Development activities set forth in the Development Plan in the manner set forth in the Development Responsibility Matrix, with required quantities of the Product in final packaged form, and Comparator Drugs and Placebo, to be used in a Phase 3 Study, and any Post-Approval Study in the Development Indication.
Dermira shall diligently, in good scientific manner and in accordance with prevailing industry practices concerning the conduct of Clinical Studies, GCP, ICH Guidelines and Applicable Law, attempt to identify, or cause to be identified, and to resolve expeditiously, inconsistencies and deficiencies in Product Data from any Phase 3 Study, or any Post-Approval Study in the Development Indication, conducted by or on behalf of Dermira.