Advanced therapy investigational medicinal product definition

Advanced therapy investigational medicinal product means an investigational medicinal product which is an advanced therapy medicinal product as defined in point (a) of article 2(1) of Regulation (EC) No 1394/2007 of the European Parliament and of the Council (1);
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Advanced therapy investigational medicinal product means an investigational medicinal product which is an advanced therapy medicinal product as defined in point
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Advanced therapy investigational medicinal product. (“ATIMP”) means a ATMP as defined in Article 2(1) of Regulation 1394/2007 which is tested or used in accordance with Article 2(d) of Directive 2001/20/EC;
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Related to Advanced therapy investigational medicinal product

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Step therapy protocol means a protocol or program that establishes the specific

  • 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.

  • Manufacturing Process means any process for—

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following: