For your convenience, the Xavier Combination Products Summit presentations are loaded onto this page as they are received from the presenters, unless a presenter has requested that their presentation not be posted. In keeping with Xavier’s conservation commitment, printed versions of presentations will not be available at the conference. If you have any questions, please contact Heather Harwood, Director, Art & Communications, at harwoodh@xavier.edu.


Comparability Bridging Studies for Combination Products: Leveraging Current Knowledge

Presenters:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, FDA-CDER

  • Irene Chan, Deputy Director, Division of Medication Error Prevention and Analysis, FDA-CDER

  • Alan Stevens, Assistant Director, Division of Drug Delivery, General Hospital, and Human Factors, FDA-CDRH

  • John Towns, Senior Research Fellow, Global Regulatory Affairs, Eli Lilly


Connected Digital Technologies: An FDA Update on the Evolving Regulatory Landscape

Presenters:

  • Kristina Lauritsen, Combination Products Regulatory Advisor, FDA-CDER

  • Demetra Macheras, Director, Regulatory Policy and Intelligence, AbbVie

  • John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA

  • Andrew Yeatts, Combination Product Policy Analyst, FDA-CDRH


Essential Performance Requirements - Latest FDA and Industry Insights on Identification and Control Strategies

Presenters:

  • Jason Lipman, Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products, Janssen

  • Alan Stevens, Assistant Director, Division of Drug Delivery, General Hospital, and Human Factors, FDA-CDRH


EU Medical Device Regulation: Preparing for Implementation

Presenters:

  • Mike Barnett, Global Associate Director - Device Quality, AstraZeneca

  • Tim Chesworth, Senior Director Regulatory Affairs - Medical Devices & Combination Products, AstraZeneca

  • Fatemeh Razjouyan, M.S., Associate Director, Regulatory Policy, Corporate Regulatory Affairs, BD


FDA Approval Pathways for Digital Health Combination Products: What Recent Regulatory Approvals and Rejections Mean for You

Presenters:

  • Demetra Macheras, Director, Regulatory Policy and Intelligence, AbbVie

  • Krystin Meidell, Manager, Regulatory Affairs CMC Combination Products and Medical, Biogen

  • Chin-Wei Soo, DRSc, Global Regulatory Head, Combination Products, Devices, Digital Health, Genentech, a member of the Roche Group


Office of Combination Products: Strategic Priorities and Action

Presenters:

  • Thinh Nguyen, Director, Office of Combination Products, FDA

  • John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA


Post Approval Changes: ICH Q12 and FDA Guidance

Presenters:

  • Ashley Boam, Director, Office of Policy for Pharmaceutical Quality, FDA-CDER

  • Sue Holmes, Director, Development Projects, Global Regulatory Affairs, RD Chief Regulatory Office, GSK

  • Maryam Mokhtarzadeh, M.D., Senior Medical Officer, Office of Combination Products, FDA


Post-Market Safety Reporting: Be Ready for the New Requirements

Presenters:

  • Khaudeja Bano, Head Of Medical Affairs, Abbott Molecular Inc.

  • Melissa Burns, Senior Program Manager, FDA

  • John “Barr” Weiner, Associate Director for Policy, Office of Combination Products, FDA


SaMD - Software Quality Management Systems for Combination Products

Presenter:

  • Kim Trautman, Executive Vice President, Medical Device International Services, NSF International


Successful Practices and Challenges for Supplier Partnering

Presenters:

  • Heather Guerin, Ph.D., P.E., Associate Director, Global CMC Regulatory Affairs, Medical Devices and Combination Products, Janssen

  • Meera Raghuram, Director, Regulatory Strategy and Policy, Lubrizol Advanced Materials, Inc and Chair, Regulatory Affairs Committee, IPEC- Americas