Xavier is the place to be for Combination Products
Experience the Xavier Difference at CPS:
- Interact with FDA and industry experts.
- Network with your colleagues and share challenges.
- Accelerate your product approval by learning about new streamlined FDA processes.
- Work through an advanced case study and participate in deep dive sessions with the experts.
- Create action plans to implement right away.
Register now for Combination Products Summit 2017, happening September 11-13.
Pre-Summit Workshop: Combination Products Foundations
And don’t miss out on the Pre-Summit Combination Products Foundations Workshop, September 11.
The CPS Experience
Take Part in the Fireside Chat with FDA
FDA Officials Thinh Nguyen (OCP), Barr Weiner (OCP), John Mcmichael (CDRH), Richard Lostritto (CDER), Melissa Burns (OCP), and Jim Dunnie (ORA) have all been invited to join the summit-ending Fireside Chat to engage in rich, meaningful conversations with you.
FDA Office Hours: Meet One-on-One with Thinh Nguyen and Barr Weiner
Thinh Nguyen and Barr Weiner will hold 15-minute office hour sessions on September 11. All available appointment slots have been filled at this time.
Pre-Summit Combination Products Summit Foundations Workshop
In this foundational workshop, participants will be exposed to challenges, expectations and successful practices for management of combination products throughout the total product lifecycle.
Actionable insights on these topics and more:
- Office of Combination Products: Strategic Priorities and Action
- Global Regulatory Strategies for Combination Product Registration and Change Management
- Drug vs. Device vs. Combination Product Development: A Foundation
- Practical Stability and Shelf-Life Successful Practices and Considerations
- Verification, Validation and Summative Human Factor Testing
CPS Quick Stats
CPS Attendees' Area of Expertise (By Percentage)
CPS Attendees' Level of Expertise (By Percentage)
CPS Attendees' Organization Size (By Percentage)
CPS 2017 Sponsors
Because of the generosity of these sponsors, we can continue our work to improve the combination products industry. Thank you!
Experience the Xavier Difference
There are three key outcomes that we look to deliver through CPS:
- Feel the purpose-driven nature of this summit as soon as you enter the room.
- Expect orchestrated engagement with your peers across the industry on topics you are passionate about.
- Find attendees openly sharing their expertise to help advance the industry in collaboration with regulators.
- Work side-by-side with regulators to deepen the understanding on both sides of challenges and opportunities.
- Identify solutions that will protect your patients around the world, your company brand, and your business.
- Talk about the “elephant in the room” to get to the real pain that plagues our industry.
- Learn what you didn’t know you didn’t know! Walk away with real solutions.
- Hear directly from speakers who passionately challenge the status quo.
MAKING A DIFFERENCE
- Work through real working models that can improve the reliability of your product…today.
- Learn how you can be part of the solution.
- Understand who your stakeholders are so you can implement meaningful and sustainable change.
- Leave the conference armed with action plans that are orchestrated throughout the summit and solidified before you leave.