Convergence 2026: Shaping the next 50 years of regulatory
RAPS Convergence 2026 is an opportunity for regulatory professionals to reflect on the evolution of the profession, look ahead to the changes brought on by new technologies, and redouble their focus on the end goal of delivering safe and effective products to patients.
RAPS Convergence is being held from 15-17 September 2026 in Charlotte, NC.
RAPS 50th anniversary
This year’s Convergence coincides with RAPS 50th anniversary, with Tuesday’s opening plenary, The Gold Standard is You: Celebrating 50 Years of Regulatory Affairs Leadership, touching upon that theme.
“Regulatory has undergone a marked transition in recent years,” said Tyler Vandivort, regulatory affairs lead at UCB Pharma, and a member of the Convergence Planning Committee.
“Convergence has been part of that evolution, bringing people together over the years to exchange experiences, discuss new developments, and make connections,” said Planning Committee member Francis Dekker, director, global regulatory affairs at Oxoid Remel Microbiology. “RAPS 50th anniversary is a great moment to reflect on how far we have come and where the profession is going next.”
Kamana Singh, CEO and founder of APS Pharma Solutions, who also serves on the Planning Committee, concurred. “Understanding the arc of regulatory development over the past five decades is essential, especially as today’s landscape is defined by scientific acceleration, digital transformation, and increasing expectations for transparency and global alignment.”
Session highlights
“Innovation is of course one of the main topics. We see AI, digital health, new medical devices and therapies developing very quickly, and regulatory frameworks need to evolve alongside them,” Dekker said, noting the increasingly complex and global regulatory landscape.
“It is not just about knowing the regulations. We need to stay up to date, understand new technologies, be involved early, and think practically about how we can use new tools to navigate the regulatory process more efficiently, while keeping patient safety at the center,” Dekker added. “The Convergence program brings these themes together and gives a great opportunity to learn from how others are approaching these challenges.”
“I'm really excited for Wednesday's plenary, The Patient Perspective: Why Our Work Matters, featuring panelists from the Parent Project Muscular Dystrophy. It feels like we are truly starting off with the end goal in mind,” Vandivort said.
The Health Authority Forum and FDA Forecast sessions on Wednesday and Thursday, respectively, are perennial favorites, Vandivort added.
For those interested in FDA legislative reform, Vandivort encouraged attendees to check out the session, The Convergence of Regulatory and Politics: A Closer Look at Congressional Proposals to Reform FDA, on Wednesday. The Advancing Simultaneous Global Marketing Approvals: Industry and Regulator Perspectives session on Thursday should “make for really good discussion,” he added.
“I’m especially energized by the innovative topics within the Skill Building sessions,” throughout the conference, Singh said. “In today’s rapidly evolving regulatory environment, particularly with the rise of AI, core regulatory skills are being reshaped, and it’s essential for professionals to revisit, refine, and expand these capabilities.”
She added that she’s enthusiastic about the Wednesday session, Diverse Women in Regulatory Affairs: Leadership and Career Pathways.
“I would highlight the sessions around the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). With the revision proposal now being discussed in Europe, it will be interesting to hear different views on what is being proposed, why these changes are being considered, and what they could mean in practice,” Dekker said.
Select sessions include MDR/IVDR State of Play and MDR Transition, both on Wednesday, and two sessions on Thursday: Best Practices in MDR/IVDR Conformity Assessment Processes: Lessons Learned for SaMD and AI-Integrated Medical Devices and Environmental Convergence: Horizontal EU Requirements Reshaping Medical Device and IVD Regulation.
“Several threads run across the program this year,” said Angelina Lisandrelli, director of global regulatory, advertising, and promotion at Intuitive Surgical, who also served on the Planning Committee, including artificial intelligence and machine learning, evolving regulatory pathways, and evidence generation to better serve patients. Three sessions on Thursday touch on those themes, including Predetermined Change Control Plans (PCCPs) Across the Device Lifecycle, Enhancing Medical Device Safety Through Cybersecurity Guidance, and Closing the Gap: Timely Evidence for Pregnancy and Breastfeeding in Clinical Trials.
She also called attention to two sessions, FemTech and Beyond: Addressing Sex-Based Disparities in Medical Devices and Pharmaceuticals, which she will be presenting on, and the China Medtech Session: Latest Updates and Hot Topics From Pre- to Postmarket, both on Wednesday.
Additionally, Lisandrelli urged attendees to participate in the Speed Mentoring sessions. “You may walk away with information that changes your career path, and perhaps with a mentor to help guide you along the way,” she said.
Advice to attendees
“For me, one of the strengths of RAPS Convergence is simply having so many people from the regulatory community together in one place, from industry, health authorities, academia, and different parts of healthcare,” said Dekker. “Be curious and participate.”
“To get the most out of Convergence, attendees should come prepared with a clear plan for both learning and networking. Identify the sessions that matter most to you, review the agenda in advance, and map out the topics that align with your current projects or career goals,” Singh said. “Equally important is the relationship-building aspect of Convergence … this is often where the real long-term value of Convergence emerges,” she said.
“Make time to meet new peers. Some of my best connections and closest friendships in this profession came out of [these] networking events,” Lisandrelli agreed.
