×
Don't Miss Out!
Get your weekly Breakfast Briefing eNewsletter, filled with news, trends, and vital information from DIA!
Back to Agenda
Global Development of Novel Combination Products: Regulatory and Clinical Case Studies from Biotech and Pharma Sponsors
Session Chair(s)
Kevin Johnson, PhD, MBA
Global Head, Regulatory Affairs
Novella Clinical, United States
Human Factors Evaluations Throughout Combination Product Development Optimizes Performance and Streamlines Regulatory Review
Learning Objective : Differentiate triggers for product development strategies based on geography and endpoints; Describe methods to ensure clinical programs meet global requirements; Identify best practices in fostering regulatory body communication and relationships to ensure timely approvals.
Speaker(s)
Human Factors Evaluations Throughout Combination Product Development Optimizes Performance and Streamlines Regulatory Review
Cynthia Joan Nolte, PhD
Aptiv Solutions, United States
Director, Medical Device Regulatory Services
Good Manufacturing Practices and Postapproval Changes for Combination Products
Suzanne M. O'Shea, JD
Faegre Baker Daniels, United States
Counsel
FDA's Evolving Standards on Product Classification and Interpretation of the Effect of Chemical Action
James S. Cohen
McDermott Will and Emery, United States
Partner, Head, FDA Practice
Have an account?