Past RAPS Fellows Inductees

The RAPS Fellows program was launched in 2008 to recognize senior regulatory professionals for their continued significant contributions and leadership in advancing the profession. Fellows receive a dignified status and hold the FRAPS designation, and serve as important resources for strategic dialog, implementation of special initiatives and international development.

2016 RAPS Fellows | 2015 RAPS Fellows | 2014 RAPS Fellows | 2013 RAPS Fellows | 2012 RAPS Fellows | 2011 RAPS Fellows | 2010 RAPS Fellows | 2009 RAPS Fellows | 2008 RAPS Fellows

2016 RAPS Fellows

2016 RAPS Fellows

The 2016 RAPS Fellows honored during The Regulatory Convergence in San Jose.

  • Ayse Baker, FRAPS, Global Regulatory Affairs Head, GE Healthcare
  • Meredith Brown-Tuttle, RAC, FRAPS, Vice President, Regulatory and Quality, Lyric Pharmaceuticals Inc.; CEO, Regulatorium
  • Nicole Landreville, RAC, FRAPS, Regulatory Affairs Program Manager, GE Healthcare
  • Erin Oliver, RAC, FRAPS, Global Regulatory Lead, Rx-to-OTC Switch, GSK Consumer Healthcare
  • Debra Rasmussen, RAC, FRAPS, Global Regulatory Affairs Diagnostic Leader/Senior Director, Janssen Pharmaceutical
  • Kimberly Walker, RAC, FRAPS, Global RA and QA Consultant, Kim Walker Consulting

2015 RAPS Fellows

2015 RAPS Fellows

The 2015 RAPS Fellows were honored during The Regulatory Convergence in Baltimore.

  • Karen Bannick McQuoid, FRAPS, Principal and Founder, Bannick Consulting LLC
  • Patricia Anderson, FRAPS, RAC, Vice President Regulatory Service, MAPI
  • Marcela Saad, FRAPS, RAC, President & Senior Consultant, MaroM Consulting
  • Sabina Hoekstra-van den Bosch, FRAPS, Senior Manager Regulations and Standards, Philips
  • Gert Bos, FRAPS, PhD, Head of Regulatory and Clinical Affairs, BSI Notified Body
  • Heather Rosecrans, FRAPS, Executive VP, Medical Devices & Combination Products, GreenLeaf Health, LLC
  • Arthur Brandwood, FRAPS, PhD, Chief Executive Officer, Brandwood Biomedical
  • Claudia Ising, FRAPS, Head of Regulatory Affairs, Lohmann & Rauscher GmbH & Co. KG
  • Margaret Mucha, FRAPS, Director of Global Regulatory Affairs, Mortara Instruments, Inc.
  • Jennifer Paine, FRAPS, RAC, Executive VP, Worldwide Quality, Regulatory & Compliance, Othro Clinical Diagnostics, Inc.

2014 RAPS Fellows

2014 RAPS Fellows

The 2014 RAPS Fellows were honored during 2014 RAPS: The Regulatory Convergence in Austin.

  • Don Boyer, RAC, FRAPS, Director, Business Transformation, Health Canada
  • Jos Kraus, PharmD, FRAPS, Senior Consultant, Academic Medical Center Amsterdam
  • Ron Schoengold, RAC, FRAPS, Principal, E Gold Solutions Consulting
  • Manfred Ruthsatz, RPh, DABT, RAC, FRAPS, Global Head Regulatory Advocacy, Nestlé Health Science

2013 RAPS Fellows

2013 RAPS Fellows

The 2013 RAPS Fellows were honored during 2013 RAPS: The Regulatory Convergence in Boston.

  • Yvonne Middlefell, FRAPS, Executive Director Regulatory Affairs, NSF Health Sciences
  • Diane Salditt, FRAPS, Distinguished Regulatory Advisor, Medtronic Inc.
  • David Mullis, PhD, RAC, FRAPS, Director, Regulatory Affairs Ed. Prog, University of Georgia College of Pharmacy
  • Thomas Hutchinson, MS, RAC, FRAPS, Vice President, Regulatory Affairs, Davol Inc.
  • Denise McEachern, RAC, FRAPS, Vice President Global Regulatory Affairs, Bausch & Lomb

2012 RAPS Fellows

2012 RAPS Fellows

The 2012 RAPS Fellows were honored during 2012 RAPS: The Regulatory Convergence in Seattle.

  • Philippe Auclair, PhD, FRAPS, Senior Director Regulatory Strategy and Advocacy EMEA/Abbott Vascular Intl., Abbott
  • Christopher Bentsen, MS, RAC, FRAPS, Manager, Regulatory Affairs, Quality Assurance & Clinical Affairs, Bio-Rad Laboratories
  • David Chadwick, PhD, RAC, FRAPS, Director, Regulatory Affairs/Regulatory Science, Cook Inc.
  • David Parsons, PhD, FRAPS, Vice President, Regulatory Affairs, GSK Consumer Healthcare
  • Donna-Bea Tillman, PhD, MPA, FRAPS, Senior Consultant, BCG
  • Elaine Messa, RAC, FRAPS, EVP Medical Device Practice, Becker & Associates Consulting
  • Felix Khin-Maung-Gyi, PharmD, MBA, CIP, RAC, FRAPS, CEO, Chesapeake Research Review Inc.
  • Mark DuVal, Esq, FRAPS, President, DuVal & Associates PA
  • Nancy J. Gertlar, RAC, FRAPS, Senior Assessor Quality Systems and Regulatory Affairs, Conmed Corporation
  • Shoshana Friedman, RAC, FRAPS, Corporate VP QA, Regulatory Affairs and Clinical Studies, novoGI Inc.
  • Sarah J. Powell, RAC, FRAPS, Executive Director, Regulatory Strategies, Liquent
  • Sathyanarayana Upadrashta, PhD, RAC, FAAPS, FRAPS, Senior Director, Global Regulatory Affairs - CMC, Millennium: The Takeda Oncology Company

2011 RAPS Fellows

2011 RAPS Fellows

The 2011 RAPS Fellows were honored during 2011 RAPS: The Regulatory Convergence in Indianapolis.

  • Joy Frestedt, PHD, CCTI, RAC, FRAPS, President and CEO, Frestedt Inc.
  • Richard M. Lewis, PhD, FRAPS, CEO, Access BIO, LLC
  • Patrick J. McCullagh, PHD, FRAPS, Vice President, Global Regulatory Affairs, K2m, Inc.
  • Virginia Perry, RAC, FRAPS, President, Perry-D'Amico & Associates
  • Nancy Singer, JD, RAC, FRAPS, President, Compliance-Alliance
  • Linda F. Bowen, MS, RAC (US/CDN/EU), FRAPS Senior Director, Regulatory Policy Intelligence, Sanofi-Aventis
  • Gretchen Bowker, RAC, FRAPS, CEO, Pearl IRB, LLC
  • Maria E. Brittle, PhD, RAC, FRAPS, Associate, Forward Motion Enterprises, LLC
  • Subhash R. Patel, RAC, FRAPS, Global Regulatory Affairs Consultant, MD Reg Consulting
  • Peter A. Takes PhD, RAC, FRAPS, Senior Director, Clinical & Healthcare Compliance and Clinical Compliance Officer, Stereotaxis Inc.
  • Susumu Nozawa, RAC, FRAPS, Director, Technical & Regulatory Policy/Corporate Regulatory Affairs, Becton, Dickinson & Company

2010 RAPS Fellows

2010 RAPS Fellows

The 2010 RAPS Fellows were honored during the 2010 RAPS Annual Conference in San Jose.

  • Elsa Abruzzo, RAC, FRAPS, President/CEO, Abruzzo Regulatory Affairs Consulting (ARAC) LLC
  • Carolyn Albertson, FRAPS, Senior Director, Global Regulatory and Government Affairs, Abbott Corporate Quality and Regulatory
  • Grace Bartoo, PhD, RAC, CBA, FRAPS, CEO, Decus Biomedical LLC
  • Martha Bennett, RAC, FRAPS, President, Bennett & Company
  • Alan Donald, MS, MBA, RAC, FRAPS, President, Matrix Medical Consulting Inc.
  • Mina Gerber, MS, RAC, FRAPS, Senior Director, Quality Assurance, GTC Biotherapeutics Inc.
  • Margaret Hurley, MD, FRAPS, President and CEO, Hurley Consulting Associates Ltd.
  • Susan James, FRAPS, Vice President, Worldwide Regulatory Affairs, R&D Compliance and Quality, GlaxoSmithKline Consumer Healthcare
  • Susan Mondabaugh, PhD, FRAPS, Vice President, Regulatory Affairs, Hurley Consulting Associations Ltd.
  • Helen Ribbans, MBA, RAC, FRAPS, President, B&H Consulting Services Inc.
  • Barry Sall, MA, RAC, FRAPS, Principal Consultant, Parexel Consulting
  • Valentina Theisz, MSc, RAC, FRAPS, Regulatory Operations Manager, Pfizer
  • Melissa Walker, MS, RAC, FRAPS, Senior Vice President, Regulatory, Quality and Compliance, Stereotaxis Inc.

2009 RAPS Fellows

2009 RAPS Fellows

The 2009 RAPS Fellows were honored during the 2009 RAPS Annual Conference & Exhibition in Philadelphia.

  • Chas Burr, MS, MBA, Graduate Program Director, Health Product Regulation, Regis College; and President and Principal Consultant, Chas Burr Q/R Services Inc.
  • Joy Cavagnaro, PhD, DABT, RAC, President and Founder, Access BIO
  • Nancy Chew, MS, RAC, President, Regulatory Affairs, North America Inc.
  • Michael Hamrell, PhD, RAC, President, MORIAH Consultants
  • Marie D. Kuker, RPh, RAC, President, Kuker Regulatory Consulting LLC
  • Philip T. Lavin, PhD, Executive Chairman, Averion International
  • Kenneth F. Miles, PhD, RAC, Principal Consultant, Miles Technologies Group LLC
  • Penny Northcutt, RAC, CQA, President and CEO, REGSolutions LLC
  • Peggy Pence, PhD, RAC, President and Executive Officer, Symbion Research International Inc.
  • Kathryn Rangus, MS, MBA, RAC, President, Drug & Device Regulatory Services Inc.
  • Robert Schiff, MS, PhD, RAC, CQA, President and CEO, Schiff & Company Inc.
  • David C. Steinberg, MBA, President, Steinberg & Associates Inc.
  • Susan Stewart, RAC, Vice President, Regulatory Affairs, TransMolecular Inc.
  • O. Reed Tarwater, PhD, RAC, Director, Pharmaceutical Consulting Services, Anson Group
  • Henrietta Ukwu, MD, FACP, Vice President, Global Regulatory Affairs, Wyeth Pharmaceuticals
  • Pamela Williamson, MBA, RAC, Senior Vice President, Global Regulatory Affairs and Corporate Quality, Genzyme Corporation

2008 RAPS Fellows

2008 RAPS Fellows

The 2008 RAPS Fellows were honored during the 2008 RAPS Annual Conference & Exhibition in Boston.

  • Susan Alpert, MD, PhD, Senior Vice President, Chief Regulatory Officer, Medtronic Inc., Minneapolis, MN
  • Neil Armstrong, Chief Executive Officer, MeddiQuest Ltd., Welwyn Garden City, UK
  • Martha Carter, RAC, Senior Vice President, Regulatory Affairs and Quality Assurance, Proteon Therapeutics Inc., Waltham, MA
  • Andrea Chamblee, RAC, Senior Compliance Officer, Otsuka America Pharmaceutical Inc., Silver Spring, MD
  • Bogdan Dziurzynski, DPA, RAC, Consultant, Sweetwater, Cardinal, VA
  • S. Albert Edwards, PharmD, RAC, Director, Regulatory Affairs, Takeda Pharmaceuticals Products Inc., Lake Forest, IL
  • Jethro Ekuta, Group Director, Bristol-Meyers Squibb Company, Pennington, NJ
  • Mark Gordon, MS, RAC, Vice President, Global Regulatory Advocacy and Policy, Boston Scientific Corporation, Natick, MA
  • Shelia Hemeon-Heyer, JD, RAC, Vice President, Global Regulatory Affairs, Boston Scientific Corporation, Natick, MA
  • Douglas Hunt, Senior Director, Regulatory Affairs, Baxter Healthcare, Westlake Village, CA
  • Tamima Itani, Vice President, Global Regulatory Affairs, Baxter Healthcare, Deerfield, IL
  • David Jefferys, Senior Vice President, Global Regulatory Affairs, Eisai Europe, Ltd., London, UK
  • Cheri Jones, MS, RAC, Vice President, Regulatory Affairs, Peplin Operations USA Inc., Emeryville, CA
  • Cecilia Kimberlin, RAC, Vice President, QA/RA/Medical Affairs, Medical Products, Abbott Laboratories Inc., Abbott Park, IL
  • Charma Konnor, PharmD, RAC, Executive Director/Consultant, Drugs and Devices, Phoenix Regulatory Associates Ltd., Ocean View, DE
  • Alison Lawton, Senior Vice President, Global Market Access, Genzyme Corporation, Cambridge, MA
  • Donald Middlebrook, Vice President, Corporate Quality Assurance and Regulatory Affairs, Thoratec Corporation, Pleasanton, CA
  • Michael Morton, RAC, Senior Director, Corporate Regulatory Affairs, Medtronic Inc., Minneapolis
  • William Morton, RAC, Founder and President, Medical Device Consultants Inc., North Attleboro, MA
  • Rodney Ruston, RAC, Director, Priory Analysts Ltd., Milton Keynes, UK
  • S. Michael Sharp, Senior Vice President, Regulatory and Clinical Affairs, ConforMIS Inc., Burlington, MA
  • Sue Sutton-Jones, Senior Vice President, RA/QA, OraSure Technologies Inc., Bethlehem, PA
  • Rainer Voelksen, RAC, Executive, International Regulatory Affairs, GE Healthcare, Buc Cedex, France
  • John L. Webster, RAC, Managing Director, Medical Device Consultants International Ltd., Crawley, UK
  • Joyce Williams, RAC, Principal Consultant, ProFocus Regulatory Solutions, La Jolla, CA
  • Winifred Wu, Vice President, Regulatory Affairs, Medtronic Neuromodulation, Minneapolis, MN
  • Robert Yocher, RAC, Vice President, Regulatory Affairs and Corporate Quality Compliance, Genzyme Corp., Framingham, MA