Presentations

For your convenience the presentations that will be made at MedCon 2014 are loaded onto this page as we receive them from the presenters, unless a presenter has requested 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 Mason Rick, Program Manager, at 513-745-3016 or rickm@xavier.edu.
Speakers Event Name Presentation
Paul Brooks EU Regulations: New Regulations, Company Strategy and Open Discussion
Steve Silverman Office of Compliance Update
Jay Crowley and Steve Niedelman How to Implement the UDI Requirements
Lawrence "Jake" Romanell and Mark Heller Managing Scientific and Regulatory Disagreement
Patrick Caines, Rebecca Hoffman, and Gina Brackett Operationalizing Post-Market Surveillance
Marian Lee and Kyle Peterson FDA Regulation of Health Information Technology
Julie Aker Understanding Changes to Patient Labeling Requirements
Susan Rolih, Dennis Hahn, Lenore Faulhaber, Monica Wilkins, Steve Binion, and Nancy Singer Changing Perceptions-Moving from Necessary Evil to a Strategic Partner
Thinh Nguyen and John "Barr" Weiner What to Expect in 2014 with Combination Products
Christy Foreman Updates from ODE Leadership
Pat Baird and Francis Blacha Implementing Effective Risk Management Programs
Christy Foreman Increasing the Integrity and Efficiency of the 510(k) Process
Thinh Nguyen, John Weiner, Suzanne O'Shea, and Francis Blacha Combination Products Working Session
Jennifer Goode and David Eaker Impact of the Changes to the FDA Biocompatibility Guidance
Gina Brackett, Marla Phillips, Monica Wilkins, and Joe Pinto Purchasing Controls--"How to"
David Eaker, Heather Rosecrans, Susan Rolih Successfully Navigating the Pre-Sub Process
Landon Lack Strategic Thinking on Access in China
Mark Parmon, Merril Racke, and Dennis Hahn Understanding and Addressing the Challenges of Import
Gina Brackett, Laureen Geniusz, and Ben Dastoli FDA Investigator Insights