For your convenience, the FDA/Xavier MedCon 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.


2018 MedCon Presentations

 

Align Your Organization with the FDA PreMarket Priorities

Presenter: Dr. William Maisel, Deputy Center Director for Science, Acting Director for ODE, Acting Director for the Office of Compliance, FDA-CDRH


The Balance of Benefit and Risk – FDA Insight

Presenters: Pat Baird, Regulatory Head of Global Software Standards, Philips; Randall Brockman, M.D., Acting Deputy Director, Clinical, Office of Medical Products and Tobacco, Office of Device Evaluation, FDA-CDRH; Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH


Beyond Metrics Through the Power of Artificial Intelligence: Applications You Can Use in Quality Today

Presenters: Xavier AI Initiative - CPQA Team: David Lonza, Head of EU, Lachman Consultant Services; Xavier AI Initiative - CLS Team: Mac McKeen, Fellow, Regulatory Science Boston Scientific; Mohammed Wahab, Quality Head, Professional Services - Informatics & Analytics, Abbott Laboratories, Diagnostic Division


The CDRH 510(k) Review Template: A Demo of the 510(k) Smart Template Used by CDRH Reviewers to Review 510(k)s

Presenter: Patrick Axtell, Program Operations Staff, Office of Device Evaluation, FDA-CDRH


Center Director Corner: Strategic Priorities for 2018 and Beyond

Presenter: Jeff Shuren, Director of the Center for Devices and Radiological Health, FDA


China - Land of Opportunity and Challenges

Presenter: Gert Bos, Executive Director & Partner, Qserve Group; Effie Lin, Ph.D., Director Regulatory Affairs, Abbott Vascular


Digital Health Innovation...The Future is Now

Presenters: Carl Kraenzel, Vice President & Distinguished Engineer, Chief Information Security Officer, IBM Watson Health; Joshua Lloyd, Director of Operations, OptoQuest; Murali Mani, Director of Compliance, IBM Watson Health; Bakul Patel, Associate Center Director for Digital Health, FDA-CDRH


EU Regulations: Beyond the Unknown

Presenters: Philippe Auclair, Senior Director, Regulatory Strategy and Advocacy, Abbott; Bassil Akra, Vice President, TÜV SÜD Product Service


FDA Office of Regulatory Affairs Update and Strategic Priorities

Presenters: Blake Bevill, Program Division Director, OMDRHO, Division 2 Central, FDA; Joe Matrisciano, Divisional Director, Office of Medical Device and Radiological Health Operations, Division 1, FDA; Anne Reid, Southeast Region, Acting Regional Food and Drug Director, FDA


FDA PostMarket Update and Strategic Priorities

Presenter: CAPT Sean M. Boyd, Deputy Director for Regulatory Affairs, Office of Compliance, FDA-CDRH


FDA Rethinks Handling of Corrections & Removals, Allegations, and 483 Responses

Presenters: Pat Baird, Regulatory Head of Global Software Standards, Philips; Gina Brackett, Director Compliance Branch, FDA; Adam Saltman, Medical Officer, Office of Compliance, FDA-CDRH


How Best to Interact with CDRH—Premarket and Postmarket

Presenters: Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding; Heather Rosecrans, Executive Vice President, Medical Devices & Combination Products (Vice President Regulatory Affairs, MDMA), Greenleaf Health


How to Effectively Implement the New 510(k) Guidance Expectations

Presenters: Marjorie Shulman, Chief of Premarket Notification (510(k)) Section, FDA-CDRH; April Veoukas, Director, Regulatory Affairs, Abbott


How to Leverage the Pre-Submission Program

Presenters: Maureen Dreher, Ph.D., Biomedical Engineer, FDA (remote); Vineet Erasala, Chief Operations Officer, Genetesis; Audrey Munnerlyn, Senior Director, Regulatory Affairs, Johnson & Johnson Vision; Caroline Rhim, Ph.D., Executive Director, NSF International


How Medical Device Firms are Gearing Up for Compliance with Europe’s New Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)

Presenters: Gert Bos, Executive Director & PartnerQserve Group; Frank Fucile, Senior Director, Regulatory Affairs, STERIS; Susan Rolih, Executive Vice President, Regulatory and Quality Systems, Meridian Bioscience, Inc.; Michael Viscido, Sr. Director, Quality & Technical Services, Mallinckrodt, Inc.; Monica Wilkins, Divisional Vice President of Medical, Clinical, Quality and Strategic Support, Abbott


IMDRF, Regulatory Convergence, and Practical Implementation

Presenters: Jackie Elkin, Global Process Owner Standard Product Identification, Medtronic; Nancy Shadeed, Special Advisor, International Programs Division, Health Canada; Melissa Torres, Associate Director for International Affairs, Center for Devices and Radiological Health, FDA-CDRH


Investigator Insights and Breaking News

Presenters: Gina Brackett, Compliance Officer, FDA; Ben Dastoli, Investigator, Medical Device Specialist, FDA; Laureen Geniusz, Medical Device Specialist, Cincinnati District, FDA; Phil Pontikos, National Device Expert, FDA


Leverage Real World Evidence for a Streamlined PreMarket Submission Process

Presenters: Paul Coplan, ScD, MBA, FISPE, Vice President, Head of Medical Device Epidemiology, Johnson & Johnson; Rachel Rath, Deputy Director, National Evaluation System for Health Technology Coordinating Center (NESTcc), Medical Device Innovation Consortium (MDIC)


New Laws That Can Shut You Down if You Are Not Prepared

Presenters: Amanda Klingler, Partner, FDA and Life Sciences Practice, King & Spalding; Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding; James O’Reilly, Professor, University of Cincinnati, College of Law


Regulatory Convergence Strategies (ISO 13485)

Presenters: Brian Ludovico, Executive Director, MDSAP Regulatory Certification, NSF International; Scott Sardeson, International Regulatory Affairs and Quality Compliance Leader, 3M; Kim Trautman, Executive Vice President, Medical Device International Services, NSF International


Streamlining the PMA Process

Presenters: Barbara S. Fant, Pharm.D., President, Clinical Research Consultants, Inc.; Joshua Nipper, Chief of Premarket Approval Staff, Office of Device Evaluation, FDA-CDRH; Steve Silverman, J.D., Vice President, Technology and Regulatory Affairs, AdvaMed


Understanding and Applying Critical to Quality Principles in Device Design

Presenters: Ben Dastoli, Investigator, Medical Device Specialist, FDA-ORA; Steve Niedelman, Lead Quality System & Compliance Consultant, King & Spalding; Phil Pontikos, National Device Expert, FDA; Bleta Vuniqi, Quality System Specialist, Division of Manufacturing and Quality, Office of Compliance, FDA