2018 Featured Speakers

2018 Summit Agenda Highlights

Actionable insights on these topics and more:

  • FDA Strategic Priorities and Action for Combination Products
  • Interactive Pre-market Submission Solutions
  • Global Regulatory Strategies for EU MDR Changes
  • Navigating the Digital Health Technology Regulatory Landscape
  • Post-market Safety Reporting Proven Practices
  • GMP and Control Strategies - Risk Control and Inspections
  • Post-Approval Change Management Case Studies

Xavier is the Place to be for Combination Products

Experience the Xavier Difference:

  • Engage with FDA and industry experts continuously.
  • Network with your colleagues and share successful practices.
  • Accelerate your product approval by implementing new streamlined FDA processes.
  • Explore the complexities of real-world advanced case studies and participate in deep dive sessions with the experts.
  • Create action plans to implement meaningful change in your organization.

Register now for Combination Products Total Program, September 12-14, 2018

Almost a perfect meeting of minds between academia, regulatory agencies and industry thought leaders to serve the only purpose – safety and public health in combination products”
Please change if needed to flow better.
— Khaudeja Bano, M.D., Head of Medical Affairs, Abbott Molecular

Summit Attendees' Area of Expertise (By Percentage)

Summit Attendees' Level of Expertise (By Percentage)


Summit Attendees' Organization Size (By Percentage)


2018 Summit Sponsors - Thank You!

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 Xavier:

Inspiring Collaboration

  • 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.

Leading Innovation

  • 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.