7:45 AM - 8:30 AM
Join your colleagues for a complimentary warm breakfast to jump-start Day 2!
8:30 AM - 9:50 AM
Case Studies: Global Regulatory Strategies for Combination Product Registration and Change Management
The session will utilize pre-filled syringe and drug-eluting stent case studies to help participants work through learnings from Day 1 and apply them to real life scenarios. Case studies will come from the FDA cGMP guidance for combination products (Case Studies A and C) participants will work collaboratively to address new challenges related to those scenarios.
- Suzanne O’Shea, Navigant Consulting
- Ashley Boam, FDA - CDER
- Rick Chapman, Biogen
- Jason Lipman, Johnson & Johnson
- John McMichael, FDA-CDRH
- Kirsten Paulson, Pfizer
- Suzette Roan, Biogen
- John “Barr” Weiner, FDA
9:50 AM - 10:10 AM
10:10 AM - 11:55 AM
Post-Market Reporting Challenges and Successful Practices for Combination Products
The speaker will simplify the Final Rule as it applies to a combination product with a Device and a Drug/Biologic Primary Mode of Action. This scenario based discussion will give participants a clear understanding of how to address the challenges facing their product in the market.
- Marla Phillips, Xavier University
- Khaudeja Bano, Abbott Diagnostics
11:55 AM - 12:40 PM
Lunch Networking by Topic
Sit with FDA officials, speakers, industry experts and your colleagues at tables dedicated to topics that are important to you. Enjoy the discussion with others who share your passion on the following topics:
- Part 4 Inspection Readiness
- Post-Market Challenges
- Global Regulatory Strategies
12:40 PM - 1:55 PM
21 CFR Part 4 Inspection Readiness
A panel of FDA and industry experts will share their unique perspectives and experiences preparing for combination product regulatory inspections and associated outcomes. Speakers will discuss specifics on key considerations associated with part 4 compliance, challenges encountered, implementation of changes to quality systems and lessons learned. Conference participants will engage in table discussions and share key challenges associated with part 4 implementation at their facility.
- Francis Blacha, Eli Lilly
- Sandra Boyd, Biogen
- Melissa Burns, FDA
- James Dunnie, FDA
1:55 PM - 2:15 PM
2:15 PM - 3:15 PM
Fireside Chat with FDA
In a world of uncertainy as it relates to combination product development, quality system readiness, product approval, evolving regulations and expectations, our FDA panel members will take your questions in an informal, collaborative setting that gets to the heart of your most pressing challenges. Don’t miss this opportunity to engage with FDA and your industry colleagues in a session to remember
- Susan Neadle, Johnson & Johnson
- Ashley Boam, FDA - CDER
- John “Barr” Weiner, FDA - OCP
- Melissa Burns, FDA - OCP
- James Dunnie, FDA - ORA
- John McMichael, FDA - CDRH
- Thinh Nguyen, FDA - OCP
3:15 PM - 3:35 PM
To Your Success!
Thank you for joining us, but we insist that you leave with action plans that will enable you to make a difference in your organization and for the patients you serve. Work with your colleagues on turning your learning into a practical action plan.
Speaker: Marla Phillips, Xavier University