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BY: VRUSHALI(20) FORAM(13) JALPA(16) HARDIKA(22) :

SHIVRATH COE IN CLINICAL RESEARCH 1 BY: VRUSHALI(20) FORAM(13) JALPA(16) HARDIKA(22) THERAPEUTIC PRODUCTS DIRECTORATE (TPD)

OUTLINE:

OUTLINE Introduction Activities Divisions and their responsibilities 2 SHIVRATH COE IN CLINICAL RESEARCH

What Is Therapeutic Products Directorate???:

What Is Therapeutic Products Directorate??? SHIVRATH COE IN CLINICAL RESEARCH 3

INTRODUCTION:

INTRODUCTION Health Canada's Therapeutic Products Directorate (TPD) is the Canadian federal authority. It is located in Ottawa, Ontario. It regulates pharmaceutical drugs and medical devices for human use. 4 SHIVRATH COE IN CLINICAL RESEARCH

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TPD works closely with its Health Canada partners as well as other regulatory agencies and the provincial and territorial governments. TPD also collaborates with scientists and agencies around the world, such as the United States' Food and Drug Administration, the European Medicines Agency and Australia's Therapeutic Goods Administration. SHIVRATH COE IN CLINICAL RESEARCH 5

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Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy and quality as required by the FDA and Regulations . This evidence is reviewed by scientists and physicians to determine whether the potential risks from the products are acceptable when balanced against the benefits for the product's proposed use. SHIVRATH COE IN CLINICAL RESEARCH 6

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The legislative framework under which TPD operates includes the: Canada Health Act Food and Drugs Act (Food and Drug Regulations, Medical Devices Regulations) Patent Act Financial Administration Act Access to Information Act and Privacy Act Controlled Drugs and Substances Act Public Service Modernization Act SHIVRATH COE IN CLINICAL RESEARCH 7

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SHIVRATH COE IN CLINICAL RESEARCH 8 WHAT TPD DOES?

ACTIVITIES:

ACTIVITIES Review Clinical Trial Applications for pharmaceuticals and Investigational Testing for medical devices to ensure the studies are properly designed and that participants will not be exposed to undue risk; Conduct a review of scientific information to evaluate the safety, efficacy and quality of a pharmaceutical, disinfectant or medical device and assess the potential benefits and risks of the product; SHIVRATH COE IN CLINICAL RESEARCH 9

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Review information that the manufacturer intends to provide to health care practitioners and consumers about the product Provide access to non-marketed drugs/medical devices to practitioners treating patients when conventional therapies have failed, are unsuitable, or unavailable Provide Canadians with science-based information they need to make informed choices SHIVRATH COE IN CLINICAL RESEARCH 10

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Monitor and review health product safety and effectiveness information as it becomes available to ensure the benefit/risk balance remains acceptable. SHIVRATH COE IN CLINICAL RESEARCH 11

ORGANIZATION :

ORGANIZATION Director General's Office and Associate Director General's Office Medical Devices Bureau Submission and Information Policy Division (SIPD) Office of Business Transformation Office of Clinical Trials Office of Patented Medicines and Liaison Office of Risk Management 12 SHIVRATH COE IN CLINICAL RESEARCH

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Bureau of Policy, Science and International Programs Bureau of Cardiology, Allergy and Neurological Sciences Bureau of Gastroenterology, Infection and Viral Diseases Bureau of Metabolism, Oncology and Reproductive Sciences Bureau of Pharmaceutical Sciences 13 SHIVRATH COE IN CLINICAL RESEARCH

RESPONSIBILITIES:

RESPONSIBILITIES Director General’s Office and Associate Director General’s Office Director General: Dr. Supriya Sharma Associate DG: Om er Boudre au Medical Devices Bureau Director : Don Boyer Device Evaluations Device Licensing Device Surveillance Special Access Program (medical devices) Quality Systems 14 SHIVRATH COE IN CLINICAL RESEARCH

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Submission and Information Policy Division (SIPD) Director: Anne Bowes Submission Processing (drugs) Performance Reports (drugs) Information Dissemination and Publications DIN Issuance and Notification Office of Business Transformation Director: Kevin Doyle Business Transformation Strategy Planning and Administration Regulatory Project Management 15 SHIVRATH COE IN CLINICAL RESEARCH

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Office of Clinical Trials Clinical Trial Applications Quality (Chemistry and Manufacturing) Reviews (for clinical trials) Office of Patented Medicines and Liaison Director: David K. Lee Administration of Patent Medicines Regulations Liaison with Justice Canada on litigation matters concerning drug reviews Patent Register 16 SHIVRATH COE IN CLINICAL RESEARCH

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Office of Risk Management Risk Management Special Access Programme (drugs) Bureau of Policy, Science and International Programs (BPSIP) Director: Brigitte Zirger Policy and Regulatory Development International Cooperation and Harmonization Science Advisory Committees 17 SHIVRATH COE IN CLINICAL RESEARCH

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Bureau of Cardiology, Allergy and Neurological Sciences Director: Siddika Mithani Clinical and Pre-clinical Reviews (prescription pharmaceuticals) Bureau of Gastroenterology, Infection and Viral Diseases Director: Jacques Bouchard Clinical and Pre-clinical Reviews (prescription pharmaceuticals) Nonprescription Drug Evaluations and Labelling 18 SHIVRATH COE IN CLINICAL RESEARCH

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Bureau of Metabolism, Oncology and Reproductive Sciences Director: Paul Roufail Clinical and Pre-clinical Reviews (prescription pharmaceuticals) Bureau of Pharmaceutical Sciences Director: Andrew Adams Clinical Comparative Bioavailability Data Evaluations (all pharmaceuticals) Quality (Chemistry and Manufacturing) Reviews (all pharmaceuticals) 19 SHIVRATH COE IN CLINICAL RESEARCH

REFERENCE:

REFERENCE www.hc-sc.gc.ca/index-eng.php SHIVRATH COE IN CLINICAL RESEARCH 20

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SHIVRATH COE IN CLINICAL RESEARCH 21 Thank You