TPDHC definition

TPDHC means the Therapeutic Products Directorate of Health Canada.
Sample 1Sample 2Sample 3

Examples of TPDHC in a sentence

  • Neither Party will employ any personnel, and will knowingly use a contractor or consultant, debarred (or a similar sanction) by a Regulatory Authority in the Initial Territory, or who is subject of an FDA or TPDHC debarment investigation or proceeding (or similar proceeding of a regulatory authority in the Initial Territory), in connection with the Development, Commercialization or manufacturing of the Products or the Compound.

  • As of the Effective Date, Takeda has not employed and, to its knowledge, has not used a contractor or consultant that has employed, any individual or entity debarred by the U.S. or TPDHC, or, to the knowledge of Takeda, any individual who or entity which is the subject of a debarment investigation or proceeding (or similar proceeding) of the FDA or TPDHC.

  • Then, TPD-HC and/or CVG could meaningfully summarize all these results to verify if they might be helpful.

  • As of the Effective Date, SPI has not employed and, to its knowledge, has not used a contractor or consultant that has employed, any individual or entity debarred by the U.S. or TPDHC, or, to the knowledge of SPI, any individual who or entity which is the subject of a debarment investigation or proceeding (or similar proceeding) of the FDA or TPDHC.

  • Hence, it was suggested that the sponsors of the submission or the CROs, with the sponsor’s permission, recapitulate the results of these 15% repeats and send their comments in a non-confidential-scientific format directly to TPD-HC and/or to CVG.

  • The LLOQ verification is prepared by spiking a clean control material with the analyte(s) of interest at 0.5 - 2 times the LLOQ concentration level(s).

  • The workshop audience agreed in considering the enormous amount of data accumulated by TPD-HC from 1992 to 2003, which is a very important source of information to evaluate the validity and efficacy of the incurred sample re-analysis approach retrospectively.

  • The SAA states: In the past, the Department of Commerce (Commerce) has countervailed a variety of programs where the government has provided a benefit through private parties.

  • The figure presents both the results from the manual delineation and the automatic segmentation by MvMM for comparisons.

  • However, the Therapeutic Products Directorate of Health Canada (TPD-HC) revoked the incurred sample re- analysis in 2003.

Related to TPDHC

  • tpd means tonnes per day.

  • PMDA means Japan’s Pharmaceuticals and Medical Devices Agency or any successor entity thereto.

  • EMEA means the European Medicines Agency.

  • cGCP means the current clinical practice as set out in (i) ICH Harmonized Guidance on current Good Clinical Practice (CPMP/ICH/135/95), (ii) US Code of Federal Regulations, Title 21, Chapters 50, 54, 56, 58, 210, 211 and 312, as may be amended from time to time, or (iii) the equivalent law or regulation in any other applicable jurisdiction in the Collaborator Territory.

  • Health Canada means the department of the Canadian Government known as Health Canada and includes, among other relevant branches, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

  • MPCA means the Minnesota Pollution Control Agency or Minnesota Pollution Control Agency staff as delegated by the Minnesota Pollution Control Agency.

  • NHTSA means National Highway Traffic Safety Administration.

  • Rural health clinic means a rural health clinic as defined under section 1861 of part C of title XVIII of the social security act, chapter 531, 49 Stat. 620, 42 U.S.C. 1395x, and certified to participate in medicaid and medicare.

  • cGLP means current good laboratory practice standards as defined by the FDA pursuant to 21 CFR Part 58 (or in the case of foreign jurisdictions, comparable regulatory standards), and in any successor regulation or any official guidance documents issued by a Regulatory Authority.

  • NYSDEC means the New York State Department of Environmental Conservation.

  • SAMHSA means the Substance Abuse and Mental Health Services Administration.

  • 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.

  • EMA means the European Medicines Agency or any successor agency thereto.

  • Biological safety cabinet means a containment unit suitable for the preparation of low to moderate risk agents where there is a need for protection of the product, personnel, and environment, according to National Sanitation Foundation (NSF) Standard 49.

  • Drug therapy management means the review of a drug therapy regimen of a patient by one or more pharmacists for the purpose of evaluating and rendering advice to one or more practitioners regarding adjustment of the regimen.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • PSC means the New York State Public Service Commission.

  • PDMA means the Prescription Drug Marketing Act of 1987, as amended, and the regulations promulgated thereunder from time to time.

  • TMA means the Taxes Management Xxx 0000;

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

  • MAA means a Marketing Authorization Application, in relation to any Product, filed or to be filed with the EMA (or equivalent national agency), for authorization to place a medicinal product on the market in the European Union (or any other territory).

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • Designated mental health professional means a mental health

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.