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Combination Products: An Overview of Clinical Benefits, Regulatory Issues, and Manufacturing Challenges

Track:
Medical Devices, In Vitro Diagnostics, and Combination Products

Day & Time:
June 18, 10:30AM - 12:00PM (Pacific Standard Time)

Session Number:
339

Room Number:
16B

Level:
Intermediate

Type:
Workshop

Title:
Combination Products: An Overview of Clinical Benefits, Regulatory Issues, and Manufacturing Challenges

Chair(s):
Michael Drues, PhD
Founder and President
Vascular Sciences, United States

Description:
Combination products are the future of medicine and pose many challenges to regulatory professionals. Using case study examples, this workshop will provide a unique learning opportunity for participants to understand this dynamic and challenging arena.

**Due to workshop format, seating will be limited and will be available on a first come, first served basis.

The San Diego Convention Center has stringent regulations on maximum room capacities, and they are strictly enforced. Once all seats are occupied, DIA will be required to close the workshop, and no more participants will be admitted. Interested attendees are encouraged to arrive at workshops early in order to ensure seating. Please note, as a workshop with interactivity, this offering will not be recorded.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Best Practices When Considering Device Development for Combination Products
Lilli Zakarija, MBA
President
EdgeOne Medical Inc, United States