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


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


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


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