Combination Products – Advanced: Strategic Thinking to Solve Combination Product Problems

  • Product development: preclinical, clinical, CMC/device; collaborative development; strategy
  • Impact of marketing application and labeling structure
  • Advertising and promotion
  • Designing and establishing quality systems
  • Device design controls, design validation, human factors
  • Designing and establishing safety reporting systems
  • Compliance and inspections
  • Other pre- and post-approval issues
  • Combination product problem analysis
  • Case studies