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Medicine / Food and Drug Administration / Clinical research / Pharmaceutical industry / Health Products and Food Branch / Center for Biologics Evaluation and Research / Biologic / European Medicines Agency / Adverse effect / Health / Pharmacology / Pharmaceutical sciences


Microsoft Word - Biologics Program Evaluation Final Report May 2014.docx
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Document Date: 2014-10-24 16:08:52


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File Size: 825,09 KB

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Company

Good Guidance Practices Good Manufacturing Practices Government of Canada Good Review / BP / Canada Gazette / Understanding Marketed Pharmaceuticals / Canada Secretariat Transfusion Errors Surveillance System / Health Canada / /

Country

United States / Canada / /

Event

FDA Phase / Product Issues / /

Facility

Gazette II Canadian Immunization Committee Canadian Institute / Human Use Institute / /

IndustryTerm

supply chain / pharmaceutical submissions / blood products / biologics manufacturing processes / food / regulatory services / quality assurance systems / therapy medicinal products / treatment of rare diseases / gene therapy products / health products / manufacturing / therapeutic products / combination products / poor-quality product / /

MedicalCondition

rare diseases / HIV / asthma / cardiovascular disease / diabetes / digestive disorders / Deficiency / /

MedicalTreatment

stem cell therapy / gene therapy / biologic therapies / innovative therapies / plasmapheresis / /

OperatingSystem

OSE / /

Organization

Noncompliance office of the Auditor General of Canada / Standard Operating Procedure Senate Standing Committee on Social Affairs / National Institute of Health / Public Health Agency / World Health Organization / Food and Drug Administration / Policy / Planning and International Affairs Directorate / Public Health Agency of Canada Evaluation Report Most / Full-time Equivalent Good Clinical Practices Good Guidance Practices Good Manufacturing Practices Government / Canadian Blood Services Canada Border Services Agency Centre for Blood / Public Health Agency of Canada / Biologics and Genetic Therapies Directorate / Radiopharmaceutical Positron Emission Tomography Public Health Agency / Public Health Agency of Canada Evaluation Report List / Human Use Institute / Public Health Agency of Canada Evaluation Report Table of Contents Executive Summary / Food Inspection Agency / Advanced Therapies Center for Biologics Evaluation / Health Products and Food Branch / Common Technical Document European Directorate for the Quality of Medicines / Blood and Tissue Evaluation Centre for Evaluation of Radiopharmaceuticals / Canadian Adverse Events Following Immunization Surveillance System Committee / federal government / Commission of Inquiry / Devices Bureau Mutual Recognition Agreement National Advisory Committee on Immunization New Active Substance Non-compliance New Drug Submission National Institutes of Health Notice of Compliance Notice of Compliance / FDA / Organs Cells / Tissues and Organs Surveillance System Centre / Regions and Programs Bureau / Krever Commission / Public Health Agency of Canada Evaluation Report / European Union / Products Directorate / Social Affairs / Science and Technology Therapeutic Access Strategy Treasury Board of Canada Secretariat Transfusion Errors Surveillance System Therapeutic Goods Administration Therapeutic Products Directorate Therapeutic Product Safety Initiative Transfusion Transmitted Injuries Surveillance System United Kingdom Variant Creutzfeldt-Jakob / Resource Management and Operations Directorate / Marketed Health Products Directorate / Canadian Immunization Committee Canadian Institute for Health Information / /

Person

DHPL DIN DM / ANDS AHRA ATMP BGTD BMP / TESS TGA TPD TPSI TTISS / /

Position

CTO / Deputy Minister / Pharmaceutical Inspection Cooperation Scheme Physician / CTO Regulations / chondroitin sulphate Official / National CTO / Executive / / /

Product

Safety / product / New Drug / /

ProgrammingLanguage

EC / /

ProvinceOrState

Quebec / /

Technology

cell therapy / Tomography / antibodies / Biotechnology / Radiopharmaceuticals / Transplantation / gene therapy / CAT / /

SocialTag