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Combination Products: An Overview of Clinical Benefits, Regulatory Issues, and Manufacturing Challenges
Session Chair(s)
Michael Drues, PhD
Founder and President
Vascular Sciences, United States
Best Practices When Considering Device Development for Combination Products
Learning Objective : Describe advantages and disadvantages of regulatory pathways available; Design/defend a most effective strategy; Manage manufacturing challenges including shelf-life, sterility, stability, etc., and know which regulations apply to which products; Recognize challenges that convergence of medical devices, drugs, and biologics pose, and acquire tactics to successfully overcome them.
Speaker(s)
Best Practices When Considering Device Development for Combination Products
Lilli Zakarija, MBA
EdgeOne Medical Inc, United States
President
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