TERMIUM Plus^®

Record 1,  Textual support,  English

Record number: 1, Textual support number: 1 OBS

The Bureau of Cardiology, Allergy and Neurological Sciences is one of the fifteen bureaus of the Therapeutic Products Directorate, a branch of the Health Products and Food Branch from Health Canada.  2, record 1, English, - Bureau%20of%20Cardiology%2C%20Allergy%20and%20Neurological%20Sciences

Record 1,  Textual support,  French

Record number: 1, Textual support number: 1 OBS

Le Bureau de cardiologie, des allergies et des sciences neurologiques est l'un des quinze bureaux de la Direction des produits thérapeutiques, une division de la Direction générale des produits de santé et des aliments de Santé Canada.  2, record 1, French, - Bureau%20de%20cardiologie%2C%20des%20allergies%20et%20des%20sciences%20neurologiques

Record 1,  Textual support,  Spanish

Record 2,  Textual support,  English

Record number: 2, Textual support number: 1 OBS

Health Canada. The Expert Advisory Committee on Cells, Tissues and Organs is a standing committee formed to provide the Biologics and Genetic Therapies Directorate(the Directorate) with timely advice on issues under federal responsibility for ensuring the safety, quality and efficacy of cells, tissues, and organs, as therapeutic products intended for transplantation. Collectively, the Committee members provide health professional and related expertise and advice pertaining to risk/benefit assessments conducted by others within Health Canada, to assist the Biologics and Genetic Therapies Directorate with making appropriate risk management decisions. The decision-making responsibility remains with the Biologics and Genetic Therapies Directorate.  1, record 2, English, - Expert%20Advisory%20Committee%20on%20Cells%2C%20Tissues%20and%20Organs

Record 2,  Textual support,  French

Record number: 2, Textual support number: 1 OBS

Santé Canada. Le Comité consultatif d'experts sur les cellules, les tissus et les organes est un comité permanent formé pour fournir à la Direction des produits biologiques et des thérapies génétiques, en temps opportun, des conseils sur les questions relevant du gouvernement fédéral afin d'assurer l'innocuité, la qualité et l'efficacité des cellules, des tissus et des organes en tant que produits thérapeutiques destinés à la transplantation. Ensemble, les membres du Comité offrent des conseils et de l'expertise dans le domaine de la santé et d'autres domaines connexes ayant trait aux évaluations des avantages et des risques effectuées par d'autres employés au sein de Santé Canada, et ce, afin d'aider la Direction des produits biologiques et des thérapies génétiques à prendre des décisions judicieuses sur la gestion des risques. La responsabilité de la prise de décisions demeure celle de la Direction des produits biologiques et des thérapies génétiques.  1, record 2, French, - Comit%C3%A9%20consultatif%20d%27experts%20sur%20les%20cellules%2C%20les%20tissus%20et%20les%20organes

Record 2,  Textual support,  Spanish

Record 3,  Textual support,  English

Record number: 3, Textual support number: 1 OBS

The Scientific Advisory Committee on HIV-Therapies(SAC-HIV-T) provides advice to the Therapeutic Products Directorate(TPD) at Health Canada on emerging issues related to HIV infections, therapies, or research. The committee advises on post-marketing requirements for new drugs, ethical and policy issues regarding drug approval and use, and issues related to the efficacy, toxicity and clinically relevant interactions of HIV therapies, as required.  1, record 3, English, - Scientific%20Advisory%20Committee%20on%20HIV%2DTherapies

Record 3,  Textual support,  French

Record number: 3, Textual support number: 1 OBS

Le Comité consultatif scientifique sur les thérapies anti-VIH (CCS-T-VIH) fournit des conseils à la Direction des produits thérapeutiques (DPT) de Santé Canada sur les nouvelles questions relatives aux infections à VIH ainsi qu'aux traitements et aux recherches connexes. Le Comité formule également des avis sur les exigences après-vente des nouveaux médicaments, les questions éthiques et stratégiques qui touchent l'approbation et l'utilisation de médicaments ainsi que les questions liées à l'efficacité, à la toxicité et aux interactions cliniques significatives des traitements des infections à VIH, le cas échéant.  1, record 3, French, - Comit%C3%A9%20consultatif%20scientifique%20sur%20les%20th%C3%A9rapies%20anti%2DVIH

Record 3,  Textual support,  Spanish

Record 4,  Textual support,  English

Record number: 4, Textual support number: 1 OBS

Health Canada. The mandate of the Scientific Advisory Committee on Bioavailability and Bioequivalence(SAC-BB) is to provide on-going and timely scientific, medical and clinical advice on current and emerging issues related to the work of the Therapeutic Products Directorate(TPD) pertaining to bioavailability and bioequivalence of drugs.  1, record 4, English, - Scientific%20Advisory%20Committee%20on%20Bioavailability%20and%20Bioequivalence

Record 4,  Textual support,  French

Record number: 4, Textual support number: 1 OBS

Santé Canada. Le mandat du Comité consultatif scientifique sur la biodisponibilité et la bioéquivalence (CCS-BB) est d'offrir en permanence des conseils scientifiques, médicaux et cliniques pertinents sur des questions actuelles et nouvelles liées aux activités de la Direction des produits thérapeutiques (DPT) en matière de biodisponibilité et de bioéquivalence des médicaments.  1, record 4, French, - Comit%C3%A9%20consultatif%20scientifique%20sur%20la%20biodisponibilit%C3%A9%20et%20la%20bio%C3%A9quivalence

Record 4,  Textual support,  Spanish

Record 5,  Textual support,  English

Record number: 5, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate.  1, record 5, English, - Bureau%20of%20Pharmaceutical%20Sciences

Record 5,  Textual support,  French

Record number: 5, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques.  1, record 5, French, - Bureau%20des%20sciences%20pharmaceutiques

Record 5,  Textual support,  Spanish

Record 6,  Textual support,  English

Record number: 6, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate.  1, record 6, English, - Office%20of%20Risk%20Management

Record 6,  Textual support,  French

Record number: 6, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques.  1, record 6, French, - Bureau%20de%20la%20gestion%20du%20risque

Record 6,  Textual support,  Spanish

Record 7,  Textual support,  English

Record number: 7, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate.  1, record 7, English, - Office%20of%20Business%20Transformation

Record 7,  Textual support,  French

Record number: 7, Textual support number: 1 OBS

Santé Canada, Bureau des produits thérapeutiques.  1, record 7, French, - Bureau%20de%20la%20transformation%20op%C3%A9rationnelle

Record 7,  Textual support,  Spanish

Record 8,  Textual support,  English

Record number: 8, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate.  1, record 8, English, - Office%20of%20Clinical%20Trials

Record 8,  Textual support,  French

Record number: 8, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques.  1, record 8, French, - Bureau%20des%20essais%20cliniques

Record 8,  Textual support,  Spanish

Record 9,  Textual support,  English

Record number: 9, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate.  1, record 9, English, - Office%20of%20Patented%20Medicines%20and%20Liaison

Record 9,  Textual support,  French

Record number: 9, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques.  1, record 9, French, - Bureau%20des%20m%C3%A9dicaments%20brevet%C3%A9s%20et%20de%20la%20liaison

Record 9,  Textual support,  Spanish

Record 10,  Textual support,  English

Record number: 10, Textual support number: 1 OBS

Health Canada. The Drugs Programme and the Medical Devices Programme were merged late in 1996, with the result that the Medical Devices Bureau joined the Drugs Directorate. Since then, they’ve been using "Drugs and Medical Devices Directorate" or "Drugs and Medical Devices Programme", as their name. As of May 1, 1997, their new name is "Therapeutic Products Directorate, "and "Therapeutic Products Programme".  2, record 10, English, - Therapeutic%20Products%20Directorate

Record 10,  Textual support,  French

Record number: 10, Textual support number: 1 OBS

Santé Canada. Le Programme des médicaments et le Programme des matériels médicaux ont été fusionnés vers la fin de 1996, ce qui a eu pour effet de faire passer le Bureau des matériels médicaux à la Direction des médicaments. Depuis lors, ils utilisent comme nom ou «Direction des médicaments et des matériels médicaux», ou «Programme des médicaments et des matériels médicaux». Depuis le 1er mai 1997, leur nom est «Direction des produits thérapeutiques», et «Programme des produits thérapeutiques».  2, record 10, French, - Direction%20des%20produits%20th%C3%A9rapeutiques

Record 10,  Textual support,  Spanish

Record 11,  Textual support,  English

Record number: 11, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate.  1, record 11, English, - Expert%20Advisory%20Committee%20on%20HIV%20Therapies

Record 11,  Textual support,  French

Record number: 11, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques.  1, record 11, French, - Comit%C3%A9%20consultatif%20d%27experts%20sur%20les%20th%C3%A9rapies%20contre%20le%20VIH

Record 11,  Textual support,  Spanish

Record 12,  Textual support,  English

Record number: 12, Textual support number: 1 OBS

Health Canada, Health Products and Food Branch. The Biologics and Genetic Therapies Directorate(BGTD) is the regulatory authority in Canada which is responsible for ensuring the safety, efficacy and quality of all biologics and radiopharmaceuticals for human use, marketed in Canada. These include blood and blood products, viral and bacterial vaccines, genetic therapeutic products, tissues, organs and xenografts, which are manufactured in Canada or elsewhere.  2, record 12, English, - Biologics%20and%20Genetic%20Therapies%20Directorate

Record 12,  Textual support,  French

Record number: 12, Textual support number: 1 OBS

Santé Canada, Direction générale des produits de santé et des aliments. La Direction des produits biologiques et des thérapies génétiques (DPBTG) est l'organisme de réglementation au Canada responsable d'assurer la sécurité, l'efficacité et la qualité de tous les produits biologiques et radiopharmaceutiques à usage humain commercialisés au Canada. Ces produits comprennent le sang et les produits sanguins, les tissus, les organes et les xénogreffes fabriqués au Canada ou ailleurs dans le monde.  2, record 12, French, - Direction%20des%20produits%20biologiques%20et%20des%20th%C3%A9rapies%20g%C3%A9n%C3%A9tiques

Record 12,  Textual support,  Spanish

Record 13,  Textual support,  English

Record number: 13, Textual support number: 1 OBS

The Therapeutic Products Directorate(TPD) Expert Advisory Panel on Di(2-ethyl-hexyl) phthalate(DEHP) in medical devices(EAP-DEHP) has been established to review the methodology and conclusions of the Exposure and Toxicity Report prepared by the Medical Devices Bureau(MDB), review and comment on the proposed risk management options, and advise the Directorate in developing position statement on DEHP in medical devices. Decision-making responsibility remains with Health Canada.  1, record 13, English, - Expert%20Advisory%20Panel%20on%20DEHP%20in%20Medical%20Devices

Record 13,  Textual support,  French

Record number: 13, Textual support number: 1 OBS

Le Groupe consultatif d'experts sur l'utilisation de diphthalate dans les matériels médicaux, à la Direction des produits thérapeutiques (DPT), a été créé pour passer en revue la méthodologie et les conclusions du rapport sur l'exposition et la toxicité rédigé par le Bureau des matériels médicaux, examiner et commenter les options proposées pour la gestion des risques et conseiller la Direction dans l'élaboration de déclarations de principes touchant l'utilisation de diphthalate dans les matériels médicaux. La prise de décisions demeure la responsabilité de Santé Canada.  1, record 13, French, - Groupe%20consultatif%20d%27experts%20sur%20l%27utilisation%20de%20diphthalate%20dans%20les%20mat%C3%A9riels%20m%C3%A9dicaux

Record 13,  Textual support,  Spanish

Record 14,  Textual support,  English

Record number: 14, Textual support number: 1 OBS

The Canadian Institute for Health Information(CIHI), the Canadian Coordinating Office for Health Technology Assessment(CCOHTA), Health Canada's Therapeutic Products Directorate and the Patented Medicine Prices Review Board(PMPRB) present Tools for Advancing Pharmaceuticals Management : Conference on Drug Utilization Indicators, Drug Standards and Drug Statistics Methodologies. The conference took place on November 24 and 25, 2004 in Ottawa, Ontario, at the Marriott Ottawa hotel.  1, record 14, English, - Tools%20for%20Advancing%20Pharmaceuticals%20Management%3A%20Conference%20on%20Drug%20Utilization%20Indicators%2C%20Drug%20Standards%20and%20Drug%20Statistics%20Methodologies

Record 14,  Textual support,  French

Record number: 14, Textual support number: 1 OBS

L'Institut canadien d'information sur la santé (ICIS), l'Office canadien de coordination de l'évaluation des technologies de la santé (OCCETS), la Direction des produits thérapeutiques de Santé Canada et le Conseil d'examen du prix des médicaments brevetés (CEPMB) présentent la Conférence sur les outils pour améliorer la gestion des produits pharmaceutiques, qui portera sur les indicateurs d'utilisation des médicaments, les normes en matière de médicaments et les méthodologies statistiques relatives aux médicaments. La conférence s'est tenue les 24 et 25 novembre 2004 à l'hôtel Marriott Ottawa, en Ontario.  1, record 14, French, - Conf%C3%A9rence%20sur%20les%20outils%20pour%20am%C3%A9liorer%20des%20produits%20pharmaceutiques%20qui%20portera%20sur%20les%20indicateurs%20d%27utilisation%2C%20les%20normes%20et%20les%20m%C3%A9thodologies%20statistiques%20associ%C3%A9s%20aux%20m%C3%A9dicaments

Record 14,  Textual support,  Spanish

Record 15,  Textual support,  English

Record number: 15, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Under ICH harmonised tripartite guideline : general consideration for clinical trials : International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1997, 9 pages.  1, record 15, English, - Timing%20of%20Non%2DClinical%20Safety%20Studies%20for%20the%20Conduct%20of%20Human%20Clinical%20Trials%20for%20Pharmaceuticals

Record 15,  Textual support,  French

Record number: 15, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Sous la Directive tripartite harmonisée de la CIH : considérations générales relatives aux études cliniques : Conférence internationale sur l'harmonisation des exigences techniques relatives à l'homologation des produits pharmaceutiques à l'usage humain. 1997, 10 pages.  1, record 15, French, - Calendrier%20des%20%C3%A9tudes%20d%27innocuit%C3%A9%20non%20cliniques%20pour%20la%20conduite%20d%27essais%20cliniques%20de%20produits%20pharmaceutiques%20sur%20des%20sujets%20humains

Record 15,  Textual support,  Spanish

Record 16,  Textual support,  English

Record number: 16, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Under ICH harmonised tripartite guideline : general consideration for clinical Trials : International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. 1997, 15 pages.  1, record 16, English, - General%20Considerations%20for%20Clinical%20Trials

Record 16,  Textual support,  French

Record number: 16, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Sous la Directive tripartite harmonisée de la CIH : considérations générales relatives aux études cliniques : Conférence internationale sur l'harmonisation des exigences techniques relatives à l'homologation des produits pharmaceutiques à l'usage humain. 1997, 19 pages.  1, record 16, French, - Consid%C3%A9rations%20g%C3%A9n%C3%A9rales%20relatives%20aux%20%C3%A9tudes%20cliniques

Record 16,  Textual support,  Spanish

Record 17,  Textual support,  English

Record number: 17, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate and Biologics and Genetics Therapies Directorate guidelines adopted from International Conference on Harmonization.  2, record 17, English, - The%20Extent%20of%20Population%20Exposure%20to%20Assess%20Clinical%20Safety%20for%20Drugs%20Intended%20for%20Long%2Dterm%20Treatment%20of%20Non%2DLife%2DThreatening%20Conditions

Record 17,  Textual support,  French

Record number: 17, Textual support number: 1 OBS

Santé Canada. Lignes directrices de la Direction des produits thérapeutiques et de la Direction des produits biologiques et thérapies génétiques provenant de la Conférence internationale sur l'harmonisation.  2, record 17, French, - Degr%C3%A9%20d%27exposition%20de%20la%20population%20et%20%C3%A9valuation%20de%20l%27innocuit%C3%A9%20des%20m%C3%A9dicaments%20destin%C3%A9s%20au%20traitement%20%C3%A0%20long%20terme%20d%27%C3%A9tats%20ne%20mena%C3%A7ant%20pas%20la%20vie

Record 17,  Textual support,  Spanish

Record 18,  Textual support,  English

Record number: 18, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate and Biologics and Genetics Therapies Directorate guidelines adopted from International Conference on Harmonization.  2, record 18, English, - Ethnic%20Factors%20in%20the%20Acceptability%20of%20Foreign%20Clinical%20Data

Record 18,  Textual support,  French

Record number: 18, Textual support number: 1 OBS

Santé Canada. Lignes directrices de la Direction des produits thérapeutiques et de la Direction des produits biologiques et thérapies génétiques provenant de la Conférence internationale sur l'harmonisation.  2, record 18, French, - Facteurs%20d%27ordre%20ethnique%20dans%20l%27acceptabilit%C3%A9%20des%20donn%C3%A9es%20cliniques%20%C3%A9trang%C3%A8res

Record 18,  Textual support,  Spanish

Record 19,  Textual support,  English

Record number: 19, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Guidelines regarding the nature of clinical studies and the target population studied.  2, record 19, English, - Studies%20in%20Support%20of%20Special%20Populations%3A%20Geriatrics%20%281994%29

Record 19,  Textual support,  French

Record number: 19, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Lignes directrices portant sur les essais cliniques et les populations cibles.  2, record 19, French, - %C3%89tudes%20%C3%A0%20l%27appui%20des%20groupes%20sp%C3%A9ciaux%20%3A%20g%C3%A9riatrie%20%281994%29

Record 19,  Textual support,  Spanish

Record 20,  Textual support,  English

Record number: 20, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate and Biologics and Genetics Therapies Directorate guidelines adopted from International Conference on Harmonization.  2, record 20, English, - Statistical%20Considerations%20in%20the%20Design%20of%20Clinical%20Trials

Record 20,  Textual support,  French

Record number: 20, Textual support number: 1 OBS

Santé Canada. Lignes directrices de la Direction des produits thérapeutiques et de la Direction des produits biologiques et thérapies génétiques provenant de la Conférence internationale sur l'harmonisation.  2, record 20, French, - Consid%C3%A9rations%20statistiques%20dans%20la%20conception%20des%20%C3%A9tudes%20cliniques

Record 20,  Textual support,  Spanish

Record 21,  Textual support,  English

Record number: 21, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. The form is requested when filing clinical trial submissions under the new regulatory framework.  3, record 21, English, - Quality%20Information%20Summary%20%2D%20Biologics

Record 21,  Textual support,  French

Record number: 21, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Le formulaire est utilisé pour la présentation des demandes d'examen d'essais cliniques selon le nouveau cadre réglementaire.  3, record 21, French, - Sommaire%20des%20donn%C3%A9es%20sur%20la%20qualit%C3%A9%20des%20produits%20biologiques

Record 21,  Textual support,  Spanish

Record 22,  Textual support,  English

Record number: 22, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate and Biologics and Genetics Therapies Directorate guidelines adopted from the International Conference on Harmonization.  2, record 22, English, - Safety%20Studies%20for%20Biotechnology%2DDerived%20Products

Record 22,  Textual support,  French

Record number: 22, Textual support number: 1 OBS

Santé Canada. Lignes directrices de la Direction des produits thérapeutiques et de la Direction des produits biologiques et thérapies génétiques provenant de la Conférence internationale sur l'harmonisation.  2, record 22, French, - %C3%89tudes%20d%27innocuit%C3%A9%20pour%20les%20produits%20issus%20de%20la%20biotechnologie

Record 22,  Textual support,  Spanish

Record 23,  Textual support,  English

Record number: 23, Textual support number: 1 OBS

Health Canada, Drugs Directorate. Issued by Therapeutic Products Programme, Ottawa, 2000, 10 pages.  1, record 23, English, - Research%20plan%20for%20marijuana%20for%20medical%20purposes%20%3A%20a%20status%20report

Record 23,  Textual support,  French

Record number: 23, Textual support number: 1 OBS

Santé Canada, Direction des médicaments. Publié par le Programme des produits thérapeutiques, Ottawa, 2000, 13 pages.  1, record 23, French, - Plan%20de%20recherche%20concernant%20l%27usage%20de%20la%20marijuana%20%C3%A0%20des%20fins%20m%C3%A9dicinales%20%3A%20%C3%A9tat%20de%20la%20question

Record 23,  Textual support,  Spanish

Record 24,  Textual support,  English

Record number: 24, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Guidelines regarding the nature of clinical studies and the target population studied.  2, record 24, English, - Dose%2DResponse%20Information%20to%20Support%20Drug%20Registration%20%281994%29

Record 24,  Textual support,  French

Record number: 24, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Lignes directrices portant sur les essais cliniques et les populations cibles.  2, record 24, French, - Donn%C3%A9es%20relatives%20%C3%A0%20la%20relation%20dose%2Deffet%20%C3%A0%20l%27appui%20de%20l%27enregistrement%20des%20m%C3%A9dicaments%20%281994%29

Record 24,  Textual support,  Spanish

Record 25,  Textual support,  English

Record number: 25, Textual support number: 1 OBS

Health Canada, Drugs Directorate, Therapeutic Products Programme guidelines, Ottawa, 1999, ii, 83 pages.  1, record 25, English, - Disinfectant%20drugs

Record 25,  Textual support,  French

Record number: 25, Textual support number: 1 OBS

Santé Canada, Direction des médicaments, Programme des produits thérapeutiques : ligne directrice, Ottawa, 1999, ii, 86 pages.  1, record 25, French, - D%C3%A9sinfectants%20assimil%C3%A9s%20aux%20drogues

Record 25,  Textual support,  Spanish

Record 26,  Textual support,  English

Record number: 26, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. The form is requested when filing clinical trial submissions under the new regulatory framework.  2, record 26, English, - Clinical%20Trial%20Application%20Form

Record 26,  Textual support,  French

Record number: 26, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Le formulaire est utilisé pour la présentation des demandes d'examen d'essais cliniques selon le nouveau cadre réglementaire.  2, record 26, French, - Demande%20d%27essai%20clinique

Record 26,  Textual support,  Spanish

Record 27,  Textual support,  English

Record number: 27, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. The form is requested when filing clinical trial submissions under the new regulatory framework.  2, record 27, English, - Clinical%20Trial%20Attestation%20Form

Record 27,  Textual support,  French

Record number: 27, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Le formulaire est utilisé pour la présentation des demandes d'examen d'essais cliniques selon le nouveau cadre réglementaire.  2, record 27, French, - Attestation%20d%27essai%20clinique

Record 27,  Textual support,  Spanish

Record 28,  Textual support,  English

Record number: 28, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate and Biologics and Genetics Therapies Directorate guidelines adopted from International Conference on Harmonization.  2, record 28, English, - Clinical%20Safety%20Data%20Management%3A%20Periodic%20Safety%20Update%20Reports%20for%20Marketed%20Drugs

Record 28,  Textual support,  French

Record number: 28, Textual support number: 1 OBS

Santé Canada. Lignes directrices de la Direction des produits thérapeutiques et de la Direction des produits biologiques et thérapies génétiques provenant de la Conférence internationale sur l'harmonisation.  2, record 28, French, - Gestion%20des%20donn%C3%A9es%20cliniques%20sur%20l%27innocuit%C3%A9%20des%20m%C3%A9dicaments%20%3A%20Rapports%20p%C3%A9riodiques%20de%20mise%20%C3%A0%20jour%20sur%20l%27innocuit%C3%A9%20des%20m%C3%A9dicaments%20commercialis%C3%A9s

Record 28,  Textual support,  Spanish

Record 29,  Textual support,  English

Record number: 29, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Guidelines regarding the nature of clinical studies and the target population studied.  2, record 29, English, - Clinical%20Safety%20Data%20Management%3A%20Definitions%20and%20Standards%20for%20Expedited%20Reporting%20%281995%29

Record 29,  Textual support,  French

Record number: 29, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Lignes directrices portant sur les essais cliniques et les populations cibles.  2, record 29, French, - Gestion%20des%20donn%C3%A9es%20cliniques%20sur%20l%27innocuit%C3%A9%20des%20m%C3%A9dicaments%20%3A%20d%C3%A9finitions%20et%20normes%20relatives%20%C3%A0%20la%20d%C3%A9claration%20rapide%20%281995%29

Record 29,  Textual support,  Spanish

Record 30,  Textual support,  English

Record number: 30, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate and Biologics and Genetics Therapies Directorate guidelines adopted from International Conference on Harmonization.  2, record 30, English, - Clinical%20Safety%20Data%20Management%3A%20Data%20Elements%20for%20Transmission%20of%20Individual%20Case%20Safety%20Reports

Record 30,  Textual support,  French

Record number: 30, Textual support number: 1 OBS

Santé Canada. Lignes directrices de la Direction des produits thérapeutiques et de la Direction des produits biologiques et thérapies génétiques provenant de la Conférence internationale sur l'harmonisation.  2, record 30, French, - Gestion%20des%20donn%C3%A9es%20cliniques%20sur%20l%27innocuit%C3%A9%20des%20m%C3%A9dicaments%20%3A%20%C3%A9l%C3%A9ments%20de%20donn%C3%A9es%20pour%20la%20transmission%20des%20rapports%20d%27innocuit%C3%A9%20sur%20les%20cas%20individuels

Record 30,  Textual support,  Spanish

Record 31,  Textual support,  English

Record number: 31, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. The form is requested when filing clinical trial submissions under the new regulatory framework.  2, record 31, English, - Adverse%20Drug%20Reaction%20%28ADR%29%20Expedited%20Reporting%20Summary%20Form

Record 31,  Textual support,  French

Record number: 31, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Le formulaire est utilisé pour la présentation des demandes d'examen d'essais cliniques selon le nouveau cadre réglementaire.  2, record 31, French, - Effets%20ind%C3%A9sirables%20des%20m%C3%A9dicaments%20%28EIM%29%20%2D%20Formulaire%20abr%C3%A9g%C3%A9%20de%20d%C3%A9claration%20rapide

Record 31,  Textual support,  Spanish

Record 32,  Textual support,  English

Record number: 32, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. The form is requested when filing clinical trial submissions under the new regulatory framework.  2, record 32, English, - Notification%20Form%20of%20Qualified%20Investigators%20and%20Canadian%20Research%20Ethics%20Boards

Record 32,  Textual support,  French

Record number: 32, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Le formulaire est utilisé pour la présentation des demandes d'examen d'essais cliniques selon le nouveau cadre réglementaire.  2, record 32, French, - D%C3%A9claration%20de%20la%20liste%20des%20chercheurs%20qualifi%C3%A9s%20et%20des%20comit%C3%A9s%20canadiens%20d%27%C3%A9thique%20de%20la%20recherche

Record 32,  Textual support,  Spanish

Record 33,  Textual support,  English

Record number: 33, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Guidelines regarding the nature of clinical studies and the target population studied.(draft 1997).  2, record 33, English, - Inclusion%20of%20Paediatric%20Subjects%20in%20Clinical%20Trials

Record 33,  Textual support,  French

Record number: 33, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Lignes directrices portant sur les essais cliniques et les populations cibles. Ébauche 1997.  2, record 33, French, - Inclusion%20des%20patients%20p%C3%A9diatriques%20dans%20les%20essais%20cliniques

Record 33,  Textual support,  Spanish

Record 34,  Textual support,  English

Record number: 34, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.  1, record 34, English, - ICH%20harmonised%20tripartite%20guideline%3A%20general%20consideration%20for%20clinical%20trials

Record 34,  Textual support,  French

Record number: 34, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Conférence internationale sur l'harmonisation des exigences techniques relatives à l'homologation des produits pharmaceutiques à l'usage humain.  1, record 34, French, - Directive%20tripartite%20harmonis%C3%A9e%20de%20la%20CIH%3A%20consid%C3%A9rations%20g%C3%A9n%C3%A9rales%20relatives%20aux%20%C3%A9tudes%20cliniques

Record 34,  Textual support,  Spanish

Record 35,  Textual support,  English

Record number: 35, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate and Biologics and Genetics Therapies Directorate guidelines adopted from International Conference on Harmonization.  2, record 35, English, - Non%2DClinical%20Safety%20Studies%20for%20the%20Conduct%20of%20Human%20Clinical%20Trials%20for%20Pharmaceuticals

Record 35,  Textual support,  French

Record number: 35, Textual support number: 1 OBS

Santé Canada. Lignes directrices de la Direction des produits thérapeutiques et de la Direction des produits biologiques et thérapies génétiques provenant de la Conférence internationale sur l'harmonisation.  2, record 35, French, - %C3%89tudes%20d%27innocuit%C3%A9%20non%20cliniques%20requises%20pour%20les%20%C3%A9tudes%20cliniques%20de%20m%C3%A9dicaments%20chez%20l%27humain

Record 35,  Textual support,  Spanish

Record 36,  Textual support,  English

Record number: 36, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Good Clinical Practice(GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.  3, record 36, English, - Good%20Clinical%20Practice%3A%20Consolidated%20Guideline

Record 36,  Textual support,  French

Record number: 36, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Une bonne pratique clinique (BPC) est une norme de qualité éthique et scientifique internationale s'appliquant à la conception et à la réalisation d'essais auxquels participent des sujets humains ainsi qu'à l'enregistrement et à la présentation des données relatives à ces essais. Le respect d'une telle norme garantit au public que les droits, la sécurité et le bien-être des sujets participant à l'essai sont protégés, conformément aux principes découlant de la Déclaration d'Helsinki, et que les données sur les essais cliniques sont fiables.  3, record 36, French, - Les%20bonnes%20pratiques%20cliniques%20%3A%20directives%20consolid%C3%A9es

Record 36,  Textual support,  Spanish

Record 37,  Textual support,  English

Record number: 37, Textual support number: 1 OBS

Health Protection Branch, Therapeutic Products Directorate, Health Canada.  2, record 37, English, - Bureau%20of%20Biologics%20and%20Radiopharmaceuticals

Record 37,  Textual support,  French

Record number: 37, Textual support number: 1 OBS

Direction générale de la protection de la santé, Direction des produits thérapeutiques, Santé Canada.  2, record 37, French, - Bureau%20des%20produits%20biologiques%20et%20radiopharmaceutiques

Record 37,  Textual support,  Spanish

Record 38,  Textual support,  English

Record number: 38, Textual support number: 1 OBS

Guidelines published in 1997 by the Therapeutic Products Directorate of Health Canada, for the Drugs Manufacturers.  2, record 38, English, - Inclusion%20of%20Women%20in%20Clinical%20Trials

Record 38,  Textual support,  French

Record number: 38, Textual support number: 1 OBS

Lignes directrices publiées en 1997 par le Programme des produits thérapeutiques de Santé Canada, à l'intention des fabricants de médicaments.  2, record 38, French, - Inclusion%20des%20femmes%20dans%20les%20essais%20cliniques

Record 38,  Textual support,  Spanish

Record 39,  Textual support,  English

Record number: 39, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. The form is requested when filing clinical trial submissions under the new regulatory framework.  3, record 39, English, - Preclinical%20and%20Clinical%20Evaluation%20Report%20Template

Record 39,  Textual support,  French

Record number: 39, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Le formulaire est utilisé pour la présentation des demandes d'examen d'essais cliniques selon le nouveau cadre réglementaire.  3, record 39, French, - Mod%C3%A8le%20du%20rapport%20d%27%C3%A9valuation%20pr%C3%A9clinique%20et%20clinique

Record 39,  Textual support,  Spanish

Record 40,  Textual support,  English

Record number: 40, Textual support number: 1 OBS

Bureau of Policy and Coordination, Therapeutic Products Directorate, Health Canada.  1, record 40, English, - Policy%20Division

Record 40,  Textual support,  French

Record number: 40, Textual support number: 1 OBS

Bureau de la politique et de la coordination, Direction des produits thérapeutiques, Santé Canada.  1, record 40, French, - Division%20de%20la%20politique

Record 40,  Textual support,  Spanish

Record 41,  Textual support,  English

Record number: 41, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. The form is requested when filing clinical trial submissions under the new regulatory framework.  3, record 41, English, - Quality%20Information%20Summary%2DPharmaceuticals%20%28Investigational%29

Record 41,  Textual support,  French

Record number: 41, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Le formulaire est utilisé pour la présentation des demandes d'examen d'essais cliniques selon le nouveau cadre réglementaire.  3, record 41, French, - Sommaire%20des%20donn%C3%A9es%20sur%20la%20qualit%C3%A9%20des%20produits%20pharmaceutiques%20%28de%20recherche%29

Record 41,  Textual support,  Spanish

Record 42,  Textual support,  English

Record number: 42, Textual support number: 1 OBS

Health Canada, Therapeutic Products Directorate. Guidelines regarding the nature of clinical studies and the target population studied.  2, record 42, English, - Preclinical%20Safety%20Evaluation%20of%20Biotechnology%2DDerived%20Pharmaceuticals

Record 42,  Textual support,  French

Record number: 42, Textual support number: 1 OBS

Santé Canada, Direction des produits thérapeutiques. Lignes directrices portant sur les essais cliniques et les populations cibles.  2, record 42, French, - %C3%89valuation%20pr%C3%A9clinique%20de%20l%27innocuit%C3%A9%20des%20produits%20pharmaceutiques%20issus%20de%20la%20biotechnologie

Record 42,  Textual support,  Spanish

Record 43,  Textual support,  English

Record number: 43, Textual support number: 1 OBS

Health Canada, Drugs Directorate, Therapeutic products programme guideline 1998, 18 pages.  1, record 43, English, - Impurities%3A%20guideline%20for%20residual%20solvents

Record 43,  Textual support,  French

Record number: 43, Textual support number: 1 OBS

Santé Canada, Direction des médicaments, directive du programme des produits thérapeutiques, Ottawa, 19 pages.  1, record 43, French, - Impuret%C3%A9s%20%3A%20directive%20sur%20les%20solvants%20r%C3%A9siduels

Record 43,  Textual support,  Spanish

Record 44,  Textual support,  English

Record number: 44, Textual support number: 1 OBS

Health Canada, Drugs Directorate, Therapeutic products programme guideline 1998, 10 pages.  1, record 44, English, - Validation%20of%20analytical%20procedures%3A%20methodology

Record 44,  Textual support,  French

Record number: 44, Textual support number: 1 OBS

Santé Canada, Direction des médicaments, directive du programme des produits thérapeutiques, Ottawa, 11 pages.  1, record 44, French, - Validation%20des%20m%C3%A9thodes%20d%27analyse%20%3A%20m%C3%A9thodologie

Record 44,  Textual support,  Spanish

Record 45,  Textual support,  English

Record number: 45, Textual support number: 1 OBS

Health Canada, Drugs Directorate, Therapeutic products programme guideline 1998, 10 pages.  1, record 45, English, - Impurities%20in%20new%20drug%20products

Record 45,  Textual support,  French

Record number: 45, Textual support number: 1 OBS

Santé Canada, Direction des médicaments, directive du programme des produits thérapeutiques, Ottawa, 11 pages.  1, record 45, French, - Pr%C3%A9sence%20d%27impuret%C3%A9s%20dans%20les%20nouveaux%20produits

Record 45,  Textual support,  Spanish

Record 46,  Textual support,  English

Record number: 46, Textual support number: 1 OBS

Health Canada, Drugs Directorate, Therapeutic products programme guideline 1998, 9 pages.  1, record 46, English, - Stability%20testing%3A%20photostability%20testing%20of%20new%20drugs%20substances%20and%20products

Record 46,  Textual support,  French

Record number: 46, Textual support number: 1 OBS

Santé Canada, Direction des médicaments, directive du programme des produits thérapeutiques, Ottawa, 11 pages.  1, record 46, French, - Essais%20de%20stabilit%C3%A9%20%3A%20essais%20de%20photostabilit%C3%A9%20des%20nouveaux%20produits%20et%20substances%20m%C3%A9dicamenteuses

Record 46,  Textual support,  Spanish