Ottawa University Course BPS 4102

This course entitled "Pharmaceuticals: Federal and International Regulations" was given to 3rd and 4th year students at the University of Ottawa from January 2005 to April 2005.

The following was the course content that was covered over the 4 month period. A similar course can be structured to fit the client's needs ...

• Food and Drugs Act and Regulations
• Schedule D Drugs/Biologics
• World Health Organization (WHO) requirements for National Regulatory Authorities
• Biologics and Genetic Therapies Directorate (Health Canada) Structure and Activities, other National Regulatory Agencies
• Drug Development Phases
• Process Development
• Development of Specifications
• Clinical Trial Material
• Pre-clinical Studies
• Good Laboratory Practice
• Containment
• Clean Room requirements
• Environmental Monitoring
• Production Process for Biologics (Seed Propagation, Fermentation, Harvest, Purification, Drug Substance, Drug Product, Formulation and Filling)
• Special Design & Operational Considerations
• Special Facilities
• Clinical Trials (Types and Requirements)
• Good Manufacturing Practice (General, for Schedule D drugs, for Blood Products)
• Establishment licensing, Inspection and On Site Evaluation
• Validation (Process Validation, Method Validation, Equipment IQ, OQ and PQ)
• Submission Types
• Review of New Drug Submissions
• ICH Common Technical Document Requirements
• Lot Release
• Changes to Marketed Drugs and Production & Regulation of Specific Vaccines

The following Guest Lectures were also included ...

• Clinical Trials & Good Clinical Practice
• Production and Regulation of Biotherapeutics
• Production and Regulation of Allergenics, Specifications and Stability for Biologics
• Regulation of Blood, Tissues and Organs
• Production & Regulation of Blood Products
• Production & Regulation of Radiopharmaceuticals
• Use of Animals in Regulation of Biologics
• Production & Regulation of Agents to combat Bioterrorism
• Plant Biologics & Regulations
• Separation Technology
• Pharmacogenomics
• Natural Health Products

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