• International drug safety landscape
• Global regulatory overview and recent developments
• Increasing complexities affecting the management of drug safety
• Safety considerations specific to biopharmaceutical products 
• Implementation of global harmonisation initiatives
• Data management and electronic submissions
• Post-marketing safety surveillance techniques and operations
• Risk minimization and management strategies
• Industry and regulatory view point of pv audits & inspections
• Financial and logistical constraints 
• In-depth look at clinical safety and the resulting limitations to pre-marketing safety testing
   

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