PDA & West Present: Combination Products

PDA & West Present the following related to Combination Products: Drug/Biologic PMOA perspective; Combination Products Risk Management and Control Strategies; and Combination Product Hot Topics, Post Approval Device Changes, and the New EU MDR Article 117 Requirements

Agenda

8:00am – 8:30am Registration

8:30am - 8:55am Coffee and continental breakfast

8:55am - 9:00am Welcome - PDA will welcome attendees

9:00am -9:45am Combination Product Development & Regulatory Best Practices Drug/ Biologic PMOA Perspective – Suzette Roan, Sr. Director, Global Regulatory Affairs Devices, Sanofi

9:45am -10:30am Combination Products Risk Management and Control Strategies – Susan Neadle, Sr. Director, Global Value Chain Quality Design, Johnson & Johnson

10:30am-10:45am Break

10:45am - 11:15am Combination Product Hot Topics; Post Approval Device Changes and the New EU MDR Article 117 Requirements—Doug Mead, Sr. Director, Regulatory Affairs, Johnson & Johnson

Preparation for Interactive Sessions – Fran DeGrazio, VP, Scientific Affairs and Technical Services

11:15am-11:30am Flexible Filling for High Value Low Volume Products – Simon Cote, Director, Technical Account, TCS, NA

11:30am -11:45am Considerations for Performance & CCI Testing and Technology – Jennifer Riter, Sr. Director, Analytical Services

11:45am - 12:30pm Lunch break and networking

12:30pm - 1:15pm Panel Discussion/Q&A—All speakers

1:15pm-1:30 pm Break into assigned groups

1:30pm – 3:30pm Networking/ Expo / Fill Finish Demonstrations/Testing Demonstrations/Technical poster exhibit

3:30pm End of event