09:00 – 09:30   Welcome & Agenda Review
    
09:30 – 10:45   AE Terminology

• Definitions & classification of key terms
• Exercise 1 – Module 1

10:45 – 11:00  BREAK 
  
11:00 – 12:00  AE Regulatory Environment 

• Regulatory requirements:
  • Canada
  • EU
  • Japan
  • US

12:30 – 01:00  LUNCH 
  
01:30 – 02:00  AE Regulatory Environment (continued)

• Exercise 2 – Module 2

02:00 – 03:00  Post-Marketing AE Reporting

• FDA & ICH  Compliance Programs
  • Program Objectives
  • Inspections
  • Administrative action
  • Minimum reporting criteria
  • Key data elements for reporting
  • Blinded studies

03:00 – 03:15   BREAK 
   
3:15 – 4:00       Post-Marketing AE Reporting

• FDA & ICH  Compliance Programs 
• Exercise 3 – Module 3
• Exercise 4 : AE Scenarios

04:00 – 4:30    Recap & Q&A

09:00 – 10:30 ICH Requirements for Clinical Safety Data Management & Reporting

• Background
• General reporting principals
• Sources of reportable information
• Describing AEs
• PSUR & Summary Bridging Reports
• Standards for non-serious AE reporting
• Exercise 5 - Module 4

10:30 – 10:45 BREAK 
  
10:45 – 12:00  Pharmacovigilance

• Risk management
• Signal detection
• Safety specification
• Pharmacovigilance methods
• Active surveillance
• Passive surveillance
• Exercise 6 – Module 5
• Exercise 7 : Completion of of SAE Report Form

12:00 – 01:00  LUNCH 
  
01:00 – 03:15  Reference Summary/Review
  
03:15 – 03:30  BREAK 
   
03:30 – 04:30  Recap & Q&A Issues