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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Gert Bos, PhD, FRAPS — Chair
Gert Bos is CSO, executive director and partner with Qserve Group in the Netherlands. He is an expert in European regulations with 28 years of experience in life sciences, including 15 years as auditor, product reviewer, regulatory specialist, and head of notified body. Bos has been leading the notified bodies in Brussels for many years and has strongly supported the regulatory debate with the EU Commission, EU Parliament, and the EU Council of Ministers. He has a PhD in biomaterial sciences, and postdoctoral degrees in controlled release of drugs and gene therapy. He is a RAPS Fellow, a founding member of the RAPS European Council and a founding board member of the RAPS Netherlands Chapter.
Jethro Ekuta, DVM, PhD, RAC, FRAPS — President
Jethro Ekuta is vice president, global regulatory affairs at Alexion Pharmaceuticals Inc. Previously, he was senior vice president, global head of regulatory, safety and standards at Horizon Pharma. Prior to that, he was vice president and global head for multiple franchises and regional head of regulatory affairs North America, Johnson & Johnson Consumer Inc. At J&J, Ekuta drove regulatory innovation and developed regulatory strategies and their execution for the R&D pipeline across the entire consumer product portfolio. He has also served in executive-level regulatory affairs positions at Genzyme, Bristol Myers Squibb Company, Wyeth Research, Pfizer Global Research and Development and Procter & Gamble Pharmaceuticals. He was also a special government employee and fellow in clinical pharmacology in FDA’s Office of Clinical Pharmacology and Biopharmaceutics.
Patricia Reis Castro, CPA — Treasurer
Patricia Reis Castro is a quality and regulatory executive at GE Healthcare, where she has worked for nearly 20 years. In that time, she has been a financial analyst, Latin American business controller, senior director of global regulatory affairs and now executive, post-market surveillance. Her expertise in post-market surveillance and regulatory includes complaint handling, adverse event reporting, CAPA, and compliance auditing processes. She also has a background in global pre-market medical-device registration processes.
Kimberly Belsky, MS — Director
Kimberly (Kim) Belsky is executive director of regulatory policy and intelligence and labeling operations at Mallinckrodt Pharmaceuticals. In this role, she is responsible for assessing changes in the global regulatory environment relevant to the company portfolio to identify opportunities and challenges in rare diseases and unmet medical needs. Additionally, she has responsibility for managing the labeling for the company’s global drug/biologic products. Belsky has more than 30 years in the pharmaceutical industry, including 20 years in regulatory affairs covering a diverse range of medical products, including prescription drug/biologics, over-the-counter medicines, nutritionals, cosmetics, and medical devices. She has served on several RAPS committees, and is the Convergence 2021 chair. Belsky received RAPS’ Community Leadership Award in 2017. She holds a master’s in chemistry from SUNY Stony Brook.
Carol Cooper, MS, IM(ASCP), RM(AAM), RAC — Director
Carol Cooper is founder and principal of CM Cooper and Associates, specializing in clinical and regulatory affairs. Her career in the healthcare industry began at Abbott Diagnostics as an HBV researcher, moving into multiple positions in clinical and regulatory affairs. Cooper’s regulatory experience is primarily in medical devices, IVDs, biologics and combination products with a special emphasis on advertising and promotion. She holds a master’s in Pharmacy from Temple University in RAQA as well as the RAC (US) credential. Cooper has been an active RAPS volunteer and has served as leader and co-leader of the RAPS Chicago Chapter and member of the Regulatory Affairs Certification Board.
Daniela Drago, PHD, RAC, FRAPS, FTOPRA — Director
Daniela Drago is the chief regulatory officer at Aurion Biotech, a position she has held since August of 2021. Her career has included leadership roles in the pharmaceutical and biotech industries, consulting organizations, and academic institutions. Drago joined Aurion Biotech from Biogen, where she led the regulatory team responsible for development products in the United States. During her time at Biogen, she was also selected as a member of Biogen’s gene therapy research and development steering committee. Prior to Biogen, Drago spent six years at George Washington University’s medical school, where she held the concurrent roles of associate professor of clinical research and leadership, and director of regulatory affairs. Her resume also includes stints at Bausch & Lomb, Hoffmann-La Roche, and Vifor Pharma.
Sabina Hoekstra-van den Bosch, PharmD, FRAPS — Director
Sabina Hoekstra-van den Bosch is regulatory strategy principal at notified body, TÜV SÜD, and acting as representative of TÜV SÜD and notified bodies in regulatory working groups at the European level. She is chair of NB-MED, the EU Commission’s working group of notified bodies, and vice-president of Team-NB, the EU notified bodies’ association. She has 20 years of experience as a pharmaceutical and medical device regulator in the Dutch government, serving subsequently in the Medicines Evaluation Board, Ministry of Health and the governmental organization for clinical investigations, CCMO. She has worked as lead for European regulation for Philips, where she acted as leader and European regulatory and expert, and was involved in EU MDR/IVDR implementation. She was co-founder and chair of the RAPS Netherlands Chapter. She is a RAPS Fellow.
Lawrence E. Liberti, PhD, RPh, RAC — Director
Lawrence (Larry) E. Liberti has worked in pharmaceutical regulatory affairs, communications, and clinical research and development (R&D) for the past four decades. He began his career at Wyeth Laboratories in product development, then as a regulatory writer in clinical R&D, and manager of safety surveillance in medical affairs. He served as the editorial director for the North American operations of Adis International, after which he founded PIA Ltd, a company specializing in regulatory writing and consulting. He co-founded Astrolabe Analytica, and has served as the executive director of the Centre for Innovation in Regulatory Science (CIRS), forming part of Clarivate Analytics. Liberti received his doctorate in international regulatory policy through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation. He holds the RAC and is a Fellow of the American Medical Writers Association.
Bill McMoil — RAPS Executive Director
Bill McMoil joined RAPS in 2017 as vice president of finance, information technology and operations. He was named executive director in December 2022. Since joining RAPS, McMoil has grown the organization from 26,000 to 30,000 members globally; staff from 40 to 50; and annual revenue by 21%. He has championed innovative and effective solutions to address the diverse educational needs of the regulatory profession. He has built a vibrant collaboration with the RAPS volunteer base (boards, committees, chapters, etc.) in support of RAPS’ diverse, and geographically distributed community. McMoil has also ensured that RAPS promotes itself as an ethical, neutral, and non-advocacy community for its more than 30,000-strong global regulatory members to connect, learn and share ideas and expanded its reach and engagement in Europe.
Frank Pokrop, RAC, FRAPS, CQE, CISA — Director
Frank Pokrop has worked in the medical device arena for more than 20 years and currently is the director for regulatory affairs at Quidel Corporation in San Diego. His manufacturing experience includes various types of devices along with large and small volume parenteral drugs. In one role with a Fortune 100 company, Pokrop was the formal liaison to FDA and worldwide health agencies. He has been an active volunteer, including as a member of MD&DI's editorial advisory board, an officer of the San Diego Regulatory Affairs Network, and a member of the IRB at UCSD. He also has taught medical device courses at UCSD, and he is a contributor and speaker with RAPS and ASQ, both locally and at national meetings.
Diana K. Salditt, FRAPS — Director
Diana Salditt leads the regulatory advocacy and policy program at Medtronic, working with Medtronic geographies and businesses and with external organizations to advocate for regulation that promotes and protects public health, and supports patients and other stakeholders. She is a RAPS Fellow and has a broad range of product and regulatory experience, including US and international regulatory submissions and compliance for combination products, medical devices, drugs and biologics. Salditt is active in organizations including device industry trade associations and the Medical Device Innovation Consortium. Prior to her current position, she held a variety of regulatory positions in Medtronic’s neurological and cardiac surgery businesses and in the in vitro diagnostics industry.
Nancy Singer, JD, LLM, RAC, FRAPS — Director
Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association, and business professionals. She is on the faculty of George Washington University School of Medicine and Health Sciences, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. She presently teaches classes for FDA Staff Colleges and FDA District Offices. Previously she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.
Susan Stewart, JD, RAC, FRAPS — Director
Susan Stewart is chief regulatory officer at Kaleido. She previously served as the company's senior vice president, regulatory affairs and quality. She has worked for more than 27 years in biopharmaceutical regulatory affairs, and has served as senior vice president of regulatory affairs, quality, and compliance at Tokai Pharmaceuticals, and vice president, regulatory affairs, at Transmolecular. She spent more than 13 years at Genzyme Corporation in regulatory and compliance roles, including serving as vice president, regulatory affairs, and also worked as an independent regulatory consultant for several years. She received her JD from Purdue University Global and LLM in health law and policy from Hofstra University. She holds both US and EU RACs.
Kimberly Trautman, MS — Director
Kimberly Trautman is executive vice president medical device international services at NSF International. Previously, she spent 26 years at FDA’s Center for Devices and Radiological Health, including as associate director of international affairs. Trautman has served as chair of the Medical Device Single Audit Program (MDSAP) regulatory council, and as chairperson of the Global Harmonization Taskforce (GHTF) Study Group 3 – Quality Systems. She is a recognized international expert in global medical device regulations, wrote and harmonized the FDA Quality System Regulation 21 CFR § 820 and was on the international authoring group of ISO 13485 since inception. While at FDA, Trautman conceived and developed the MDSAP international consortium of five global regulators, as well as its many foundational documents.