Global Regulatory Strategies for Combination Product Registration and Change Management

Presenters

  • Rick Chapman

  • Jason Lipman


Drug vs. Device vs. Combination Product Development: A Foundation

Presenter

  • Susan Neadle


Practical Stability and Shelf-Life Successful Practices and Considerations

Presenters

  • Ashley Boam

  • Steve Holcroft

  • John McMichael

  • Alberto Velez


Risk Management and Formative Human Factor studies (ISO 14971)

Presenters:  

  • Valerie Fenster

  • Sara Waxberg McNew


Verification, Validation and Summative Human Factor Testing

Presenter

  • Scott Thiel


21 CFR Part 4 Inspection Readiness

Presenters

  • Sandra Boyd

  • Melissa Burns

  • James Dunnie


Post-Market Reporting Challenges and Successful Practices for Combination Products

Presenter

  • Khaudeja Bano, Abbott Diagnostics


Case Studies: Global Regulatory Strategies for Combination Product Registration and Change Management

Presenters:

  • Ashley Boam

  • Rick Chapman

  • Jason Lipman

  • John McMichael

  • Kirsten Paulson

  • Suzette Roan

  • John “Barr” Weiner