Technical Development and Regulation of Drug (and Biologic) Delivery Devices and Systems

  • Background: anatomy, technical requirements, standards compendial and regulatory requirements for prefilled syringes and single-use disposable, reusable, general use and specific use drug delivery systems (viz., injection-, pulmonary-, nasal- and transdermal-based; safety devices and other drug delivery devices and accessories); how they work, how are they used, how they are regulated
  • History, development and analysis of relevant FDA laws, regulations, guidance, policy, organization for drug delivery devices and systems’ contrast to EU approach
  • Product development: preclinical, clinical, CMC/device; collaborative development; strategy for drug delivery devices and systems
  • Device design controls, design validation, human factors
  • Marketing applications and labeling: format and content for drug delivery devices and systems; CTD
  • Quality Systems for drug delivery devices and systems
  • Safety Reporting for drug delivery devices and systems
  • Post-approval change reporting for drug delivery devices and systems
  • Other pre- and post-approval issues for drug delivery devices and systems
  • Case studies