RAPS Convergence 2026 brought more than 2,000 regulatory and quality professionals to the Charlotte Convention Center in North Carolina. The Regulatory Affairs Professionals Society hosted the event from September 15 to 17. Preconference workshops ran on September 14 and 15. This year’s program also marked the 50th anniversary of RAPS. Over three days, more than 100 sessions covered pharmaceuticals, biologics, medical devices, and in vitro diagnostics.
Vistatec Life Sciences exhibited at booth #408 throughout the event. Maria Mateos, John Berning, and MarÃa Roa represented our team in Charlotte. They met regulatory leaders, health authority representatives, and industry peers during sessions and networking events. Many of these conversations focused on keeping multilingual regulatory content accurate as global requirements shift.
Celebrating 50 Years of Regulatory Leadership
The opening plenary looked back at five decades of regulatory affairs. Panelists recalled a time when teams worked on paper and drug reviews took years. Meanwhile, speakers stressed that the profession’s core purpose remains the same. Regulatory teams still work to bring safe and effective products to patients. RAPS also honored 14 industry champions with its 2026 awards and inducted a new class of Fellows.
Regulations Need an Update for the AI Era
Former FDA Commissioner Robert Califf delivered one of the most discussed keynotes of the week. He argued that laws built around static systems now struggle with complex, multidimensional data. As a result, he called for significant regulatory updates and described AI assistants supporting future regulatory work. This vision reinforces the value of human-centered language AI that keeps expert reviewers in control. Clear AI governance frameworks also help regulated organizations adopt these tools responsibly.
EU Pharmaceutical Reform Moves Closer
Officials from the European Commission and the European Medicines Agency presented key reforms in the EU’s proposed pharmaceutical legislation. Their session signaled significant change for sponsors bringing medicines to European markets. Consequently, companies must prepare regulatory content that adapts quickly to new requirements. Reliable translation and localization helps teams meet these expectations in every official EU language.
MDR, IVDR, and EUDAMED Readiness
Medical device and diagnostics manufacturers followed EU MDR and IVDR developments closely. A panel of European Commission, industry, and notified body experts reviewed proposed reforms to both regulations. Other sessions addressed global UDI compliance ahead of EUDAMED implementation. In addition, these changes place fresh pressure on labeling, instructions for use, and technical documentation. Strong global terminology management keeps device content consistent across markets and product lines.
Global Submissions and Simultaneous Approvals
Several sessions explored how companies can pursue simultaneous marketing approvals across multiple regions. Industry and regulator speakers discussed ways to reduce divergence and improve communication with health authorities. However, parallel submissions multiply the volume of documents that need precise translation at once. For this reason, multilingual quality management helps sponsors maintain accuracy without slowing timelines.
Overall, RAPS Convergence 2026 showed a profession preparing for faster change and greater global complexity. Our team left Charlotte with valuable insights and new connections. Want to discuss how these shifts affect your multilingual content? Speak with one of our life sciences experts today.
Planning your next global submission or EU MDR update? Explore our case studies to see how Vistatec supports regulatory teams worldwide.