RAPS 2025 Year in Review: what we accomplished, together
In 2025, the global RAPS community once again came together with a strong sense of commitment to continue the vital work that connects safe and effective healthcare products to the people who need them.
“In a year when regulatory and quality professionals spent so much time pivoting and adapting through uncertainty, the RAPS community gave us a crucial space to share our knowledge and experience, and to keep learning together.” said Jethro Ekuta, chair of the RAPS Board of Directors. “Thank you to everyone who participated. Your efforts truly helped make this year a success.”
2026 promises to be a big year for RAPS, as it marks our society’s 50th anniversary. We can’t wait to share a look back at the evolution of our profession. In addition, we are excited to peek forward at what’s to come in a world where technology is evolving fast, and healthcare is continually innovating to stay ahead.
But before we embark on another fast-paced year, let’s take a moment to celebrate all we accomplished in 2025.
What is RAPS? The Regulatory Affairs Professionals Society is the largest global organization of professionals involved with regulatory and quality for healthcare products. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources.
A growing society dedicated to connecting, developing, and celebrating regulatory and quality professionals
As 2025 draws to a close, RAPS membership is larger and more diverse than ever. Our society ends the year with more than 30,000 members helping RAPS support and elevate the professionals who connect innovative healthcare products with the patients who need them.
More than 280 mentors and more than 660 mentees participated in the second year of the RAPS Mentoring Program, where regulatory and quality professionals can give and receive advice to handle the complex challenges today’s world throws their way.
More than 900 RAPS members shared their experiences and advice in the form of 5,600+ discussion posts in RAPS’ online community, Regulatory Exchange (RegEx). Nearly 25,000 members stay connected to this forum via daily RegEx updates.
We welcomed four new professionals into the venerated ranks of the RAPS Fellows, and we celebrated nine deserving professionals and one organization with our RAPS Awards.
Professionals in Austria, Dallas-Fort Worth, Greater Cincinnati, Houston, and Pittsburgh formed new RAPS Local Networking Groups, where RAPS members foster regional connections that strengthen careers and build lasting relationships.
RAPS volunteers contributed to every initiative mentioned here (and many more that we couldn’t fit into this article). If you volunteered with RAPS this year, tag us on social media and tell us something you enjoyed about it!
A community dedicated to staying informed
The journalists at Regulatory Focus, RAPS’ independent news team, continued to cover breaking news and important trends across the industry, publishing more than 700 articles and roundups, including Regulatory Recon and This Week at FDA. Subscribe to RF Today to get their daily news and updates in your inbox every weekday.
RAPS published 50 peer-reviewed articles across four issues of the member-exclusive RF Quarterly, and as online only articles in Regulatory Focus. Starting January 2026, RAPS will publish peer-reviewed content in the new Journal of Regulatory Affairs.
In March, RAPS published Fundamentals of Medical Device Regulation: A Global Perspective, a new comprehensive global guide to medical device regulation written by more than 75 authors. This book is available in three formats: print, e-book, and e-book subscription in RAPS Library.
“It’s been an honor to contribute as a volunteer author alongside incredible subject matter experts from around the world. For me, this project was more than just writing. It was about giving back to a profession that continues to challenge, inspire, and connect us.”
Sai Prathyusha Bhamidipati
Chapter Author
Fundamentals of Medical Device Regulations: A Global Perspective
The largest regulatory affairs event in the world — and the biggest regulatory affairs event in Europe
At RAPS Convergence 2025, more than 1,500 regulatory affairs professionals assembled in Pittsburgh from 7-9 October to lead timely, extensive discussions and deepen professional bonds at the world’s largest regulatory affairs event. Across more than 150 educational sessions, attendees learned from more than 230 expert speakers, shared innovative ideas, and made crucial connections.
“Each year, I leave RAPS Convergence reminded of how much this community gives — and energized to keep learning, adapting, and giving back as our profession continues to evolve.”
Ritu Dhami
RAPS Convergence attendee
Want to present at RAPS Convergence 2026 in Charlotte, North Carolina? The Call for Proposals is open until 7 January 2026.
At RAPS Euro Convergence 2025, more than 1,000 professionals gathered for collaborative discussions on the future of regulatory affairs in Europe. At Europe’s fastest-growing regulatory affairs event, more than 200 expert presenters shared their knowledge across more than 90 sessions dedicated to the improvement and advancement of healthcare in Europe.
“Deep-dive sessions on MDR, IVDR, EUDAMED, and the AI Act showed how today’s rules shape innovation and SMEs. A live jazz band opened the plenary—proof that, just like in regulatory work, single parts matter, but real impact happens when we play in sync.”
Diana Rosentul
RAPS Euro Convergence attendee
So many chances for in-person learning and collaboration
The second full year of the RAPS Conference Series saw outstanding growth and discussions at the RAPS Regulatory Intelligence Conference and RAPS Global Regulatory Strategy Conference in March, and at the European Lifecycle Management Conference and European Digital Technology and Software Conference in October.
For the fourth year of its partnership, the AFDO/RAPS Healthcare Products Collaborative convened MedCon and the Combination Products Summit for purpose-driven discussions between regulators, industry, academia, and thought leaders about the most pressing issues facing the industry.
The second year of Combination Products in the EU, an event jointly presented by RAPS and DIA, united key stakeholders across the field of combination products to explore a coordinated drug and device approach to incentivize competitive innovation in Europe. Register for the January 2026 event here!
In 2025, RAPS gathered regulatory professionals in two new regions of the world. In February, RAPS collaborated with Mecomed to host the 2025 MEA MedTech Regulatory Summit in Dubai, a one-day, interactive event that united 135 global regulatory professionals, industry leaders, and policymakers — across 25 countries — to address the evolving regulatory landscape for medical devices in the Middle East and Africa (MEA) region. In July, RAPS partnered with the Medical Technology Association of Australia (MTAA) for the Australia Regulatory Device Summit 2025 in Sydney. The event attracted 340 attendees from 12 countries and five continents to address Australian regulatory reforms and international harmonization.
In November, RAPS and TOPRA jointly presented the Regulatory Intelligence Conference Europe and the UK MDR Conference, held back-to-back in London.
A new credential for those transitioning into regulatory affairs
RAPS introduced the Foundation in Regulatory Affairs (FRA) credential in May 2025, giving those new or transitioning into regulatory affairs a path to build and showcase the essential knowledge needed to get their careers off to the right start. 278 professionals earned their FRA in 2025.
The FRA-Introduction to Medical Devices and FRA-Introduction to Pharmaceuticals help you learn and prove your knowledge early in your regulatory affairs career. RAPS will launch two additional FRA credentials, the FRA-Global Regulatory Strategy for Medical Devices and FRA-Global Regulatory Strategy for Pharmaceuticals, in 2026.
“The introduction of a new credential is something we took very seriously after thoughtful discussion and input from regulatory professionals. The FRA combines foundational education from RAPS Online University with an assessment to provide early-career regulatory professionals with a way to demonstrate their interest in, and knowledge of, the regulatory practice.”
Brian Savoie
Senior Vice President, Education and International Programs
Regulatory Affairs Professionals Society
390 professionals earned their Regulatory Affairs Certification (RAC) credentials in 2025, validating their knowledge with a RAC-Devices or RAC-Drugs credential and joining the more than 4,500 professionals who hold a RAC globally.
96 professionals earned their Regulatory Compliance Certification (RCC) credentials in 2025, the second year RAPS offered this credential, which validates your knowledge of European regulations related to medical devices and IVDs.
Online regulatory and quality education that meets you where you are
Our community took more than 5,000 online courses across the areas of medical devices, pharmaceuticals, quality, clinical, and professional development. More than 130 professionals completed a certificate program in devices, drugs, or both.
Experts hosted 34 RAPS online workshops and 38 free webcasts where they shared their knowledge and answered live questions from more than 12,600 registrants.
In-demand educational programs helped educate regulatory and quality leaders
At the RAPS Kellogg Executive Development Program, more than 30 professionals explored business and leadership lessons from faculty at Northwestern’s Kellogg School of Management in May.
"Led by Kellogg professors, sessions covered leadership style and skills including strategic adaptation, artificial intelligence, decision making, negotiation, networking, and crisis management. Jennifer Paine and I led discussions regarding the application of these business skills to regulatory situations. Thanks to the Kellogg staff and an excellent cohort of participants for an interactive and impactful experience."
Diana Salditt
President
RAPS Board of Directors
In its third year, the RAPS eCornell Regulatory Leadership Certificate Program connected professionals from around the globe to learn from Cornell faculty in a flexible six-month online educational opportunity.
2025 was the first year of the RAPS Advanced Strategic Communications Certificate Program, where 63 experienced regulatory and quality professionals collaborated through four interactive workshops to learn and practice critical skills leaders need.
Next up: an extra special year!
In 1976, RAPS Founder Richard Greco jumpstarted the transformation of regulatory affairs from merely a collection of tasks to a bona fide profession.
Throughout 2026, we will look back at the ways our profession has evolved — and look forward to the next 50 years and beyond, culminating in our RAPS 50th Anniversary Celebration at RAPS Convergence 2026 in Charlotte, North Carolina.
We cannot wait to share more soon!