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7: Europe (EMA) and Canada (Health Canada)

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Learning Objectives:
  • Health Canada: History and Legislation
    • Canadian Food and Drugs Act and Regulations
    • Drug Classification System in Canada (Schedules of Drugs)
    • International Policy
    • Organization of Health Canada
    • Clinical Trial Review and Approval Process
    • Special Access Program
    • New and Generic Drug Submission Processes
    • GMP Requirements
    • Intellectual Property Protection
    • Pricing and Reimbursement (PMPRB)
    • Post approval changes and submissions
    • Pharmacovigilance
    • Import/Export
    • Summary
    • The European Medicines Agency (EMA)
      • European Union: History, Legislation, Institutions and Agencies
      • Eudralex - The Rules Governing Medicinal Products in European Union
      • European Medicines Agency (EMA): Committees, Working Parties and other Groups
      • Clinical Trial Application and Paediatric Investigation Plan (PIP)
      • Marketing Authorization Procedures – Centralized, Mutual Recognition, Decentralized and National
      • Summary of Product Characteristics (SmPC)
      • Drug Master File
      • Certification to European Pharmacopoeia (CEP)
      • Assembly and Submission Requirements
      • Renewal and Maintenance of Marketing Authorization (MA)
      • Scientific Advice/Meetings
      • Procedures for Variations – Changes to an approved marketing authorization
      • Patent Protection, Data Protection and Supplementary Protection Certificate (SPC)
      • Fees
      • Summary