Speakers and Moderators

Jump to: 2013 | 2012 | 2011 | 2010

2013

  • Steven B. Binion, Ph.D., MBA. Director, Corporate Regulatory/Women’s Health and Cancer, Becton Dickinson.
  • Gina Brackett. Compliance Officer. FDA Cincinnati District Office. (invited)
  • Paul Brooks. Vice President, Healthcare Solutions. BSI Product Services.
  • Benjamin Dastoli, Investigator, Medical Device Specialist.
  • Mark DuVal, President of DuVal & Associates.
  • Barbara Fant, Pharm.D. Principal Regulatory Consultant and President. Clinical Research Consultants, Inc.
  • Christy Foreman, FDA Center for Devices and Radiological Health (CDRH), Director of the Office of Device Evaluation. (Invited)
  • Laureen Geniusz, Investigator, Medical Device Specialist.
  • Dennis Hahn, RAC. Director, Regulatory Strategic Initiatives. Ethicon Endo-Surgery.
  • Suzanne Halliday. Team Leader, Orthopaedic & Dental Devices, BSI.
  • Marian Lee. Partner, FDA & Life Science Practice Group, King & Spalding.
  • Thinh Nguyen. Director, Office of Combination Products. FDA. (Invited)
  • Steven Niedelman. Lead Quality System & Compliance Consultant. King & Spalding.
  • Prof. James O’Reilly, J.D. Professor. University of Cincinnati College of Law.
  • Phil Phillips. President, Phillips Consulting Group, LLC.
  • Phil Pontikos. National Device Expert. FDA.
  • Heather Rosecrans. Senior Regulatory Advisor, Greenleaf Health LLC.
  • Dr. Jeffrey Shuren. FDA Director of the Center for Devices and Radiological Health (CDRH).
  • Steve Silverman. FDA Center for Devices and Radiological Health (CDRH), Director of the Office of Compliance.
  • Nancy Singer. Founder, Compliance Alliance.
  • Paul J. Teitell. District Director, FDA.
  • Monica Wilkins. Divisional Vice President of Quality Assurance/Regulatory Affairs. Abbott.
  • Winifred C. Wu. MBA, FRAPS, President, Strategic Regulatory Partners, LLC.

2012

  • Julius Aviza. Quality Director. Allergan
  • Edward M. Basile. Senior Partner. King & Spalding.
  • Steven B. Binion, Ph.D., MBA. Director, Corporate Regulatory. Becton Dickinson.
  • Gert Bos. Head of Regulatory and Clinical Affairs. BSI Product Services
  • Gina Brackett. Compliance Officer. FDA Cincinnati District Office.
  • Paul Brooks. Vice President, Healthcare Solutions. BSI Product Services.
  • David Cannistraci. Vice President, Regulatory Affairs and Quality Peripheral Vascular
    Division. ev3/Covidien
  • Daniel P. Carmichael, Counsel. Faegre Baker Daniels.
  • Maria Cianciotto. Managing Partner, Quality System Architects.
  • Karen A. Coleman. Senior Compliance Expert, Medical Devices. IHL Consulting Group, Inc.
  • Benjamin Dastoli, Investigator, Medical Device Specialist.
  • Mark DuVal, President of DuVal & Associates.
  • Keith Flanagan. Health Counsel, U.S. Senate Committee on Health, Education, Labor & Pensions (HELP).
  • Christy Foreman, FDA Center for Devices and Radiological Health (CDRH), Director of the Office of Device Evaluation.
  • Laureen Geniusz, Investigator, Medical Device Specialist
  • Dennis Hahn, RAC. Director, Regulatory Strategic Initiatives. Ethicon Endo-Surgery.
  • Kem Hawkins, President. Cook Group Incorporated
  • Rita Hoffman, RAC. Managing Partner RHoffman, Inc
  • Cecilia Kimberlin, PhD. Vice President, Stragetic Deployment, Quality/Regulatory/Medical, Abbott.
  • John A. Kraeutler. Chief Executive Officer, Meridian Bioscience.
  • Steven Niedelman. Lead Quality System & Compliance Consultant. King & Spalding
  • Phil Phillips. President, Phillips Consulting Group, LLC
  • Phil Pontikos. National Device Expert. FDA
  • Susan Rolih. Senior Vice President, Regulatory Affairs and Quality Assurance. Meridian Bioscience, Inc.
  • Dr. Jeffrey Shuren. FDA Director of the Center for Devices and Radiological Health (CDRH)
  • Steve Silverman. FDA Center for Devices and Radiological Health (CDRH), Director of the Office of Compliance.
  • Kenneth Sumner, PhD. Vice President, Worldwide Scientific Affairs for Ethicon Endo-Surgery Inc.
  • Paul J. Teitell. District Director, FDA.
  • Kim Trautman. Associate Director of International Affairs (CDRH), Medical Device International Quality Systems Expert
  • Monica Wilkins. Divisional Vice President of Quality Assurance/Regulatory Affairs. Abbott
  • Winifred C. Wu. MBA, FRAPS, President, Strategic Regulatory Partners, LLC

2011

  • Julius Aviza. Director. Baxter Healthcare Corp.
  • Pat Baird. Product Design Owner. Baxter Healthcare.
  • Larry Bartkus. Distinguished Engineer, Edwards Lifesciences.
  • Stefanie Bartsch. Project Director, ifa united i-tech Inc.
  • Edward M. Basile. Senior Partner. King & Spalding.
  • Jason Bennett. Sr. Principal Quality Engineer, Baxter Healthcare.
  • Maureen Bernier. Biomedical Engineer, FDA, Center for Devices and Radiological Health, Office of Compliance.
  • Steven B. Binion, Ph.D., MBA.
  • Francis Blacha. Global Quality Leader, Devices. Eli Lilly and Company.
  • Gert Bos. Head of Regulatory and Clinical Affairs. BSI Product Services.
  • Gina Brackett. Compliance Officer, Medical Device Specialist. FDA, Office of Regulatory Affairs.
  • Paul Brooks. Vice President, Healthcare Solutions. BSI Product Services.
  • Maria Cianciotto. Managing Partner, Quality System Architects.
  • Karen A. Coleman. Senior Compliance Expert, Medical Devices. IHL Consulting Group, Inc.
  • Mark DuVal, President of DuVal & Associates.
  • Barbara Fant, Pharm.D. Principal Regulatory Consultant and President. Clinical Research Consultants, Inc. 
  • Lenore Faulhaber, Ph.D., M.B.A. Senior Scientist, Product Safety and Regulatory Affairs. Proctor & Gamble.
  • Keith Flanagan. Health Counsel, U.S. Senate Committee on Health, Education, Labor & Pensions (HELP). 
  • Terri Garvin, Office of Compliance. FDA, Center for Devices and Radiological Health.
  • Mary Gilbert. Director Corporate Regulatory Affairs, Boston Scientific.
  • Danielle Giroud, RN, M.B.A.. Founder. World Medical Device Organization.
  • Barbara Immel. President. Immel Resources LLC.
  • Teresa Jimenez. Principal Consultant and President. Regulatory Expert Consultants, Inc.
  • Dr. Petra Kaars-Wiele. Director, International Regulatory Affairs & Affiliate Compliance. Abbott, Germany.
    Sharon Kapsch. Chief, MDR Policy Branch. U.S. Food and Drug Administration, Center for Devices and Radiological Health.
  • Stephen Kilker. BIMO Specialist. FDA, Cincinnati District.
  • Jan Kosmyna MIS, B.Ed., RN, CCRP. Program Manager of Vascular Surgery ARO. Cleveland Clinic. 
  • Angela Krueger. Product Jurisdiction Officer. FDA, Center for Devices and Radiological Health.
  • Amit Kukreja. Associate Director, Synergus -A MedTech Consulting Company.
  • Bill Maisel. Deputy Director for Science. FDA, Center for Devices and Radiological Health.
  • Deborah Mange, RN, BSN. Project Manager. The Ouriel Group.
  • Stefan Menzl, PhD. Director, International Regulatory Affairs. Abbott, Germany.
  • Thinh Nguyen. Director, Office of Combination Products. FDA.
  • Steven Niedelman. Lead Quality System & Compliance Consultant. King & Spalding.
  • Prof. James O’Reilly, J.D. Professor. University of Cincinnati College of Law.
  • Dr. Kenneth Ouriel, Founder, The Ouriel Group.
  • Phil Phillips. President, Phillips Consulting Group, LLC.
  • Phil Pontikos. National Device Expert. FDA.
  • Mary Raphael. Associate Director, Marketed Health Products Directorate, Health Canada.
  • Patrick Redmon, Ph.D. Associate Professor in the Graduate Program for Health Services Administration. Xavier University.
  • Susan Rolih. Senior Vice President, Regulatory Affairs and Quality Assurance. Meridian Bioscience, Inc. 
  • Heather Rosecrans. Senior Regulatory Advisor, Greenleaf Health LLC.
  • Tom Ruthemeyer. Clinical Professor. Xavier University.
  • Barry Sands. President/Founder. RQMIS Inc.
  • Marjorie Shulman. Acting Director, 510(k) Staff. FDA, Center for Devices and Radiological Health.
  • Matthew J. Tarosky. Acting Director, Division of Bioresearch Monitoring. FDA, Office of Compliance, CDRH.
  • Bradley Thompson, J.D. General Counsel. Combination Products Coalition.
  • Teresa Thompson. District Director. Cincinnati District Office, U.S. Food and Drug Administration.
  • Monica Tocchi, MD, Ph.D. Medical Director. Meditrial Europe Ltd.
  • Kim Trautman. FDA Expert on Medical Device GMPs and Quality Systems, Office of Compliance. FDA, Center for Devices and Radiological Health.
  • April Veoukas. Director, Regulatory Affairs, Abbott Laboratories, Abbott Quality & Regulatory corporate division.
  • John Barlow Weiner. Associate Director for Policy, FDA, Office of Combination Products.
    Monica Wilkins. Divisional Vice President of Quality Assurance/Regulatory Affairs. Abbott.

2010

  • Francis Blacha. Global Quality Leader – Devices. Eli Lilly and Company.
  • Gina Brackett. Compliance Officer, Medical Device Specialist. FDA, Office of Regulatory Affairs.
  • Paul Brooks. Vice President – Country Manager. BSI Product Services.
  • Ken Charak RAC, MBA. Director of Regulatory Affairs. Ethicon Endo-Surgery, Inc.
  • Virginia Connelly. Director, Investigations Branch. U.S. Food and Drug Administration, Cincinnati District Office.
  • Karen A. Coleman. Senior Compliance Expert, Medical Devices. IHL Consulting Group, Inc.
  • Barbara Fant, Pharm.d. Principal Regulatory Consultant and President. Clinical Research Consultants, Inc. 
  • Danielle Giroud. Founder. WMDO.
  • Jonathan S. Helfgott. Consumer Safety Officer. US Food and Drug Administration, Center for Devices & Radiological Health, Office of Compliance, Division of Bioresearch Monitoring.
  • Sheryl Helsinger. Director of Clinical Operations. Ethicon Endo-Surgery, Inc.
  • Sheila Hemeon-Heyer, J.D. Vice President. Global Regulatory Affairs, Boston Scientific Corporation. 
  • Barbara Immel. President. Immel Resources LLC.
  • Jeremy Jokinen. Clinical Sciences Manager. Ethicon Endo-Surgery.
  • Sharon Kapsch. Chief, MDR Policy Branch. U.S. Food and Drug Administration, Center for Devices and Radiological Health.
  • Jos Kraus, Pharm. D. Senior Inspector of the Medical Technology of the Inspectorate of Health Care in the Netherlands.
  • Suzanne Lamerand. Vice President Clinical Data Management. DSG, Inc.
  • Michael Marcarelli, PharmD, M.S. Director, Division of Bioresearch Monitoring. Office of Compliance. FDA Center for Devices and Radiological Health.
  • Tim Missios, B.Sc., MBA. Director Regulatory Affairs, Asia Pacific and Americas. Boston Scientific Corporation.
  • Steven Niedelman. Senior Consultant to the Health Care Group. Crowell & Moring LLP.
  • Phil Pontikos. FDA National Device Expert.
  • Stephen J. Rabe. Compliance Officer. FDA, Office of Regulatory Affairs.
  • D. Patrick Redmon, Ph.D. Associate Professor in the Graduate Program for Health Services Administration. Xavier University.
  • Thomas J. Ruthemeyer, CPA, MBA. Clinical Professor. Xavier University.
  • Steve Silverman. Senior Advisor to the Director of FDA's Center for Devices and Radiological Health (CDRH).
  • Carole Stamp. Subject Matter Expert. (World Medical Device Organization).
  • Gary Stevens, Ph.D. Founder and President. DynaStat Consulting, Inc.
  • Ken Sumner, Ph.D. Worldwide Vice President of Clinical & Regulatory Affairs. Ethicon Endo-Surgery, Inc., (A Johnson & Johnson Company).
  • Teresa Thompson. District Director. Cincinnati District Office, U.S. Food and Drug Administration.
  • Kim Trautman. FDA Expert on Medical Device GMPs and Quality Systems, Office of Compliance. FDA, Center for Devices and Radiological Health.
  • Rainer Waedlich. Chairman, ifa group of companies, Healthcare IT (HIT), ifa united i-tech Inc. Ft. Lauderdale, FL.
  • Monica Wilkins. Senior Director of Quality and Compliance. Abbott Laboratories.
  • Deborah Wolf. Attorney in the Office of Compliance in the Center for Devices and Radiological Health.
  • Jack Wong. Vice Executive Secretariat General of AHWP