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.

2012 RAPS Fellows | 2011 RAPS Fellows | 2010 RAPS Fellows | 2009 RAPS Fellows | 2008 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

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

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.

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

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