RAPS Fellows Program
Honoring distinguished leaders. Advancing regulatory excellence.
The RAPS Fellows Program annually recognizes exceptional professionals who have made sustained, meaningful contributions to regulatory science, practice, and leadership. Fellowship represents the highest level of professional distinction within RAPS.
Those named Fellows exemplify integrity, service, and commitment to the global regulatory community.
What It Means to Be a RAPS Fellow and Becoming One
RAPS Fellows are respected leaders who advance the profession through mentorship, continually going above and beyond their job descriptions, and volunteerism. In recognition of their impact, Fellows receive the distinguished FRAPS designation and serve as ambassadors for regulatory excellence.
Fellowship reflects both achievement and responsibility.
Application Information and Selection Process
RAPS Fellows must have an extensive and robust process at the strategic management levels outlined in the Regulatory Competency Framework. Below is a brief overview of the criteria and responsibilities of a RAPS Fellow.
Eligibility to become a RAPS Fellow includes:
- Have an active RAPS membership
- Individuals currently employed at a health authority are excluded from this membership requirement
- Have a minimum of 10 years of extensive regulatory knowledge and breadth of experience in the profession, including healthcare and related products—medical devices, pharmaceuticals, biologics and nutritional products
- Have a history of dedication to—and an interest in continuing to build and shape—the future of the regulatory profession
RAPS Fellows responsibilities:
- Provide ongoing representation as a leader at RAPS regulatory programs and other scientific meetings
- Participate in forums covering key issues and trends facing the profession
- Serve and lead the regulatory profession and RAPS
- Assist in developing future RAPS leadership
- Mentor new and/or junior RAPS members and other regulatory professionals by providing guidance and advice
How to Apply
The 2026 RAPS Fellow Program application cycle will close on 3 April 2026 at 11:50 pm EDT. Fellows will be announced at RAPS Convergence 2026 in Charlotte, NC, USA.
-
Complete the General Candidate Information Form, so we have your general contact information and know that you are interested in applying.
-
Download the Fellows Application Form. Please ensure that you complete all fields (incomplete applications will not be reviewed).
The Fellows Application Form consists of questions about the candidate’s:- Contributions to the regulatory community
- Regulatory work history
- Regulatory management and leadership experience
- Knowledge and breadth of regulatory issues
- Plans for advancing the regulatory profession
- Credentials and references (please note that the Fellows Committee reserves the right to contact your references to verify the information supplied in your application).
- Submit the completed Fellow Application Form to Julie Gordon, Director, Membership, RAPS no later than 3 April 2026, at 11:50 pm EDT.
Additional Information
RAPS Fellows are selected annually by a peer group, the RAPS Fellows Selection Committee. When reviewing applications, the Fellow Selection Committee focuses on the applicant’s:
- Achievement of excellence in regulatory competence.
- Contribution to the profession, especially beyond the routine and daily job expectations.
- Concrete plans to continue contributing to the profession in the future.
In September, fellows will be announced and recognized at RAPS Convergence 2026 in Charlotte, NC, USA.
Reasons why some past applications did not result in Fellow recognition:
- Failure to clearly communicate the case for selection
- Failure to follow instructions or directly address the selection criteria
- Insufficient years of experience
- Contributions to the profession not sufficient/sustained
- Incomplete applications
Meet the Fellows
The RAPS Fellows Program launched in 2008 to recognize global regulatory professionals for their innovation, contributions, and leadership in advancing the profession. Fellows receive a dignified status and hold the FRAPS designation. They serve as important advisors and mentors for strategic collaboration, implementation of special initiatives, and international development across the regulatory community.
2024 RAPS Fellows

Allison Komiyama, PhD, RAC-US, FRAPS
Vice President, MedTech Innovations at RQM+

Sequita Lindsey, MSRA, RAC-Global, FRAPS
President and CEO of Lindsey Regulatory Affairs Consulting

Mindy McCann, MS, FRAPS
Principal Consultant at QServe Group

Jay Vaishnav, PhD, RAC-Devices, FRAPS, Director
Regulatory Affairs at Canon Medical Informatics
2023 RAPS Fellows

Amy Fowler, RAC, FRAPS, Esquire
President and Founder, Pathmaker FDA Law

Suzanne Halliday, MSc. DPhil.
VP Regulatory, BSI

Salma Michor, PhD, MBA, CMgr, RAC
Managing Director, QbD Group

James W. Monroe, MBA, MS, RAC, CQA
CEO & President, Global RQC Med Device Solutions, LLC

Prabu Nambiar, PhD, MBA, RAC
Principal & Founder, Syner-G BioPharma Group, LLC
2022 RAPS Fellows

Monique J. Carter, FRAPS,
Senior Director, Pfizer, Inc.

Niedre M. Heckman, FRAPS
Director, Global Regulatory Affairs, Takeda

Aman Khera, FRAPS
Vice President, Global Head, Regulatory Strategy, Worldwide Clinical Trials

Melissa O'Connor, FRAPS, RAC-US, CTBS
Chief Quality & Regulatory Officer, StimLabs, LLC

Grace Powers, FRAPS, RAC
Founder/ Principal Consultant, Powers Regulatory Consulting

Raymond Seda, FRAPS, RAC
Senior Director, Global QMS Operations, Medtronic
2019 RAPS Fellows

Lisa Baumhardt, MS, MT(ASCP), RAC, FRAPS

Bradley Hossack, SCD, FRAPS *

Georgiann Keyport, ASQ-CQA, RAC, FRAPS

Natalie Kennel, RAC, FRAPS
2018 RAPS Fellows
- Frank Pokrop, CPGP, CQA, CQE, CSQE, RAC, FRAPS
- Daniel Mannix, FRAPS
- Sandra Matsumoto, PhD, RAC, FRAPS
2017 RAPS Fellows

The 2017 RAPS Fellows honored during the Regulatory Convergence in the National Harbor at the DC Waterfront.
- Kaia Agarwal, FRAPS
- Mark De Rosch, FRAPS
- Susan Hamann, RAC, FRAPS
- Joel Kent, RAC, FRAPS
- Darin Oppenheimer, RAC, FRAPS
- Joanne Palmisano, FRAPS
2017 RAPS Fellows

The 2017 RAPS Fellows honored during the Regulatory Convergence in the National Harbor at the DC Waterfront.
- Kaia Agarwal, FRAPS
- Mark De Rosch, FRAPS
- Susan Hamann, RAC, FRAPS
- Joel Kent, RAC, FRAPS
- Darin Oppenheimer, RAC, FRAPS
- Joanne Palmisano, FRAPS
2016 RAPS Fellows

The 2016 RAPS Fellows honored during the Regulatory Convergence in San Jose.
- Ayse Baker, FRAPS
- Meredith Brown-Tuttle, RAC, FRAPS
- Nicole Landreville, RAC, FRAPS
- Erin Oliver, RAC, FRAPS
- Debra Rasmussen, RAC, FRAPS
- Kimberly Walker, RAC, FRAPS
2015 RAPS Fellows

The 2015 RAPS Fellows were honored during the Regulatory Convergence in Baltimore.
- Karen Bannick McQuoid, FRAPS
- Patricia Anderson, RAC, FRAPS
- Marcela Saad, RAC, FRAPS
- Sabina Hoekstra-van den Bosch, FRAPS
- Gert Bos, PhD, FRAPS
- Heather Rosecrans, FRAPS
- Arthur Brandwood, PhD, FRAPS
- Claudia Ising, FRAPS
- Margaret Mucha, FRAPS
- Jennifer Paine, RAC, FRAPS
2014 RAPS Fellows

The 2014 RAPS Fellows were honored during 2014 RAPS: The Regulatory Convergence in Austin.
- Don Boyer, RAC, FRAPS
- Jos Kraus, PharmD, FRAPS
- Ron Schoengold, RAC, FRAPS
- Manfred Ruthsatz, RPh, DABT, RAC, FRAPS
2013 RAPS Fellows

he 2013 RAPS Fellows were honored during 2013 RAPS: The Regulatory Convergence in Boston.
- Yvonne Middlefell, FRAPS
- Diane Salditt, FRAPS
- David Mullis, PhD, RAC, FRAPS
- Thomas Hutchinson, MS, RAC, FRAPS
- Denise McEachern, RAC, FRAPS
2012 RAPS Fellows

The 2012 RAPS Fellows were honored during 2012 RAPS: The Regulatory Convergence in Seattle.
- Philippe Auclair, PhD, FRAPS
- Christopher Bentsen, MS, RAC, FRAPS
- David Chadwick, PhD, RAC, FRAPS
- David Parsons, PhD, FRAPS
- Donna-Bea Tillman, PhD, MPA, FRAPS
- Elaine Messa, RAC, FRAPS
- Felix Khin-Maung-Gyi, PharmD, MBA, CIP, RAC, FRAPS
- Mark DuVal, Esq, FRAPS
- Nancy J. Gertlar, RAC, FRAPS
- Shoshana Friedman, RAC, FRAPS
- Sarah J. Powell, RAC, FRAPS
- Sathyanarayana Upadrashta, PhD, RAC, FAAPS, FRAPS
2011 RAPS Fellows

The 2011 RAPS Fellows were honored during 2011 RAPS: The Regulatory Convergence in Indianapolis.
- Joy Frestedt, PhD, CCTI, RAC, FRAPS
- Richard M. Lewis, PhD, FRAPS
- Patrick J. McCullagh, PHD, FRAPS
- Virginia Perry, RAC, FRAPS
- Nancy Singer, JD, RAC, FRAPS
- Linda F. Bowen, MS, RAC (US/CDN/EU), FRAPS
- Gretchen Bowker, RAC, FRAPS
- Maria E. Brittle, PhD, RAC, FRAPS
- Subhash R. Patel, RAC, FRAPS
- Peter A. Takes PhD, RAC, FRAPS
- Susumu Nozawa, RAC, FRAPS
2010 RAPS Fellows

The 2010 RAPS Fellows were honored during the 2010 RAPS Annual Conference in San Jose.
- Elsa Abruzzo, RAC, FRAPS
- Carolyn Albertson, FRAPS
- Grace Bartoo, PhD, RAC, CBA, FRAPS
- Martha Bennett, RAC, FRAPS
- Alan Donald, MS, MBA, RAC, FRAPS
- Mina Gerber, MS, RAC, FRAPS
- Margaret Hurley, MD, FRAPS
- Susan James, FRAPS
- Susan Mondabaugh, PhD, FRAPS
- Helen Ribbans, MBA, RAC, FRAPS
- Barry Sall, MA, RAC, FRAPS
- Valentina Theisz, MSc, RAC, FRAPS
- Melissa Walker, MS, RAC, FRAPS
2009 RAPS Fellows

The 2009 RAPS Fellows were honored during the 2009 RAPS Annual Conference & Exhibition in Philadelphia.
- Chas Burr, MS, MBA, FRAPS
- Joy Cavagnaro, PhD, DABT, RAC, FRAPS
- Nancy Chew, MS, RAC, FRAPS
- Michael Hamrell, PhD, RAC, FRAPS
- Marie D. Kuker, RPh, RAC, FRAPS
- Philip T. Lavin, PhD, FRAPS
- Kenneth F. Miles, PhD, RAC, FRAPS
- Penny Northcutt, RAC, CQA, FRAPS
- Peggy Pence, PhD, RAC, FRAPS
- Kathryn Rangus, MS, MBA, RAC, FRAPS
- Robert Schiff, MS, PhD, RAC, CQA, FRAPS
- David C. Steinberg, MBA, FRAPS
- Susan Stewart, RAC, FRAPS
- O. Reed Tarwater, PhD, RAC, FRAPS
- Henrietta Ukwu, MD, FACP, FRAPS
- Pamela Williamson, MBA, RAC, FRAPS
2008 RAPS Fellows

The 2008 RAPS Fellows were honored during the 2008 RAPS Annual Conference & Exhibition in Boston.
- Susan Alpert, MD, PhD, FRAPS
- Neil Armstrong, FRAPS
- Martha Carter, RAC, FRAPS
- Andrea Chamblee, RAC, FRAPS
- Bogdan Dziurzynski, DPA, RAC, FRAPS
- S. Albert Edwards, PharmD, RAC, FRAPS
- Jethro Ekuta, FRAPS
- Mark Gordon, MS, RAC, FRAPS
- Shelia Hemeon-Heyer, JD, RAC, FRAPS
- Douglas Hunt, FRAPS
- Tamima Itani, FRAPS
- David Jefferys, FRAPS
- Cheri Jones, MS, RAC, FRAPS
- Cecilia Kimberlin, RAC, FRAPS
- Charma Konnor, PharmD, RAC, FRAPS
- Alison Lawton, FRAPS
- Donald Middlebrook, FRAPS
- Michael Morton, RAC, FRAPS
- William Morton, RAC, FRAPS
- Rodney Ruston, RAC, FRAPS
- S. Michael Sharp, FRAPS
- Sue Sutton-Jones, FRAPS
- Rainer Voelksen, RAC, FRAPS
- John L. Webster, RAC, FRAPS
- Joyce Williams, RAC, FRAPS
- Winifred Wu, FRAPS
- Robert Yocher, RAC, FRAPS

















