Compassionate Use Program definition

Compassionate Use Program means a program according to which a medicinal product not authorized in Turkey – whether or not approved in other countries – is provided without charge by the originator/supplier in accordance with the guidelines and procedures described in the Guideline for Compassionate Use Program to a group of patients with a life-threatening disease or a condition that is severely disruptive of the quality of life, who cannot be enrolled in relevant clinical trials in the subject matter and in whom treatment using medicinal products already authorized/permitted by the Ministry of Health or standard therapeutic methods have failed or it is no longer possible to use these treatments;
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Compassionate Use Program means a compassionate use, patient name or similar program for supplying Special Products to certain
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Compassionate Use Program means the use of a Licensed Product or a Licensed Service as an investigational drug in accordance with applicable law outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options.
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Examples of Compassionate Use Program in a sentence

  • There shall be no debate upon any question after it has been put by the presiding Grand Officer.

  • New patients may be included in Compassionate Use Program (CUP) / Compassionate Use Named Patient (CUNP) [x] months from the Framework Agreement entry into force.

  • Indoor Harvest has developed patent pending cannabis cultivation technology to be used in the Joint Venture to develop specific intellectual property and research into the development of specific chemical expression profiles and will provide Design-Build services to Alamo CBD in the construction of its cannabis oil production facility under the Texas Compassionate Use Program.

  • Compassionate Use - Evaluate access to the Compassionate Use Program in Texas and what modifications would facilitate equal access across the state.‌‌ Legislative, Budgetary‌ 2.

  • In the event that Lilly pursues a Compassionate Use Program as described in 21 CFR Sections 312.34, 312.35 and 312.37 for treatment of patients for emergency use, or for related use on a compassionate use basis (the "Compassionate Use Program") for a particular Drug Product, Lilly and Vertex hereby agree to share all reasonable direct costs associated with such Compassionate Program as follows: [*].

  • The costs incurred for Oxypurinol projects in 2006 of $1.1 million relate to finalizing the OPT-CHF study as well as our Compassionate Use Program for allopurinol intolerant gout patients.

  • Cartilage hypertrophyIn the majority of the 370 patients included in the Compassionate Use Program, a collagen membrane instead of a periosteal flap was used to seal the defect.

  • It is her mother’s intent to continue to access this drug, if Meghan’s medical condition requires it, through the limited access program or Compassionate Use Program as it is sometimes called.

  • Reporting of spontaneously reported adverse drug reactions As indicated in FAMHP guidelines, normal pharmacovigilance requirements apply in a Medical Need or Compassionate Use Program.

  • Therefore, depending on the program, the following information should be submitted: In the context of a Compassionate Use Program (CUP), the safety information will be mentioned in the Development Safety Update Report (DSUR) in accordance with ICH E2F guideline on DSUR5.


More Definitions of Compassionate Use Program

Compassionate Use Program means a compassionate use, patient name or similar program for supplying Special Products to certain patients.
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Compassionate Use Program means a reduction in Product costs below the Supply Price granted by KYE for a specified time to patients should such patients not have drug insurance or they cannot otherwise afford the Product after KYE receives a notice of compliance from Health Canada to market the Product in the Territory. For the purposes of this Subsection “Additional Bridging Program” means a reduction in Product costs below the Supply Price granted by KYE for a limited time to patients should there be a delay in such patients’ drug insurance coverage for the Product after all Participants in Studies have been bridged per Section 2.6. KYE and Catalyst agree to equally share in the costs of the Products for any such Additional Bridging Program and Compassionate Use Program in the Territory; provided however, that Catalyst’s obligation to share in the Product costs of such Compassionate Use Program shall only apply to patients prescribed the Product for on-label indications based on Health Canada’s product monograph. At all times during the Term, KYE shall be responsible for all requirements, operational costs and oversight of any such Compassionate Use Program. For clarity at the program’s commencement, patients who do not have drug insurance shall not be eligible for the Bridging Program and may only be considered for eligibility in the Compassionate Use Program. Prior to any subsequent changes in eligibility criteria in the Compassionate Use Program, KYE will consult with Catalyst to reach agreement between the Parties on such changes.
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Related to Compassionate Use Program

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • Approved abuse education training program means a training program using a curriculum approved by the abuse education review panel of the department of public health or a training program offered by a hospital, a professional organization for physicians, or the department of human services, the department of education, an area education agency, a school district, the Iowa law enforcement academy, an Iowa college or university, or a similar state agency.

  • Child Care Program means a person or business that offers child care.

  • E-Verify Program above means the employment verification program administered by the United States Department of Homeland Security, the Social Security Administration, or any successor program.

  • Managed Care Program means the process that determines Medical Necessity and directs care to the most appropriate setting to provide quality care in a cost-effective manner, including Prior Authorization of certain services.

  • Dependent care assistance program or "DCAP" means a benefit plan whereby school employees may pay for certain employment related dependent care with pretax dollars as provided in the salary reduction plan under chapter 41.05 RCW pursuant to 26 U.S.C. Sec. 129 or other sections of the Internal Revenue Code.

  • Service Animal means an animal that is required by a person with a disability for assistance and is certified, in writing, as having been trained by a professional service animal institution to assist a person with a disability and which is properly harnessed in accordance with standards established by a professional service animal institution.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Procurement Plan means the Recipient’s procurement plan for the Project, dated April 2, 2010, and referred to in paragraph 1.16 of the Procurement Guidelines and paragraph 1.24 of the Consultant Guidelines, as the same shall be updated from time to time in accordance with the provisions of said paragraphs.

  • Prescription monitoring program “PMP,” or “program” means the program established pursuant to 657—Chapter 37 for the collection and maintenance of PMP information and for the provision of PMP information to authorized individuals.

  • Marijuana testing facility means an entity licensed to analyze and certify the safety and potency of marijuana.

  • Spatial Planning and Land Use Management Act means the Spatial Planning and Land Use Management Act, 2013 (Act 16 of 2013);

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

  • Training program means an NCA-approved Iowa college, the Iowa law enforcement academy or an Iowa hospital approved by the department to conduct emergency medical care training.

  • Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.

  • Project Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.2 of Exhibit B to the ITP.

  • Participating Hospice Care Program Provider means a Hospice Care Program Provider that either: (i) has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield to provide services to participants in this benefits program, or; (ii) a Hospice Care Program Provider which has been designated by a Blue Cross and/or Blue Shield Plan as a Participating Provider Option program.

  • Collaborative pharmacy practice agreement means a written and signed

  • Software Program means the software program used by a Fund for providing Fund and account balance information including net asset value per share. Such Program may include the Lion System. In situations where the Lion System or any other Software Program used by a Fund is not available, such information may be provided by telephone. The Lion System shall be provided to Insurance Company at no charge.

  • Tourism destination project means a qualified non-gaming business facility that will be among the most visited privately owned or operated tourism or recreation sites in the State, and which is located within the qualified incentive area and has been determined by the authority to be in an area appropriate for development and in need of economic development incentive assistance, including a non-gaming business within an established Tourism District with a significant impact on the economic viability of that District.

  • Approved program or "approved state" means a state or interstate program that has been approved or authorized by EPA under 40 CFR Part 123 (2000).

  • Shared-use path means a bikeway that is physically separated from motorized vehicular traffic by

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.

  • HIV means human immunodeficiency virus.

  • Basic Comprehensive User Guide means the Ministry document titled Basic Comprehensive Certificates of Approval (Air) User Guide” dated April 2004 as amended.

  • Planning and service area or “PSA” means a geographic area of the state that is designated by the commission for purposes of planning, development, delivery and overall administration of services under a multiyear area plan. “PSA” may be interpreted as either singular or plural dependent on context. “Provider” means any person, company, firm, association or other legal entity that provides services