As science and regulation continue to evolve at an unprecedented pace, adaptability has become a defining skill for today’s regulatory professionals. This year’s RAPS Convergence 2025, held October 7–9 at the David L. Lawrence Convention Center in Pittsburgh, brings together global experts to explore how innovation, collaboration, and agility are reshaping regulatory affairs across the life sciences industry.
Navigating an Era of Uncertainty
“This year, really, it’s a lot of uncertainties,” said Michelle Meng, VP and Head of Global Regulatory Sciences at OBI Pharma and a member of the Convergence Committee. With emerging technologies like artificial intelligence (AI), shifting global regulations, and growing public demand for transparency, Meng noted that 2025 represents both a challenge and an opportunity for the industry.
RAPS Convergence has long been a cornerstone for regulatory professionals seeking to stay ahead of industry trends. The 2025 event emphasizes not only innovation but also adaptability—helping attendees understand how to respond to rapid changes in regulatory frameworks while maintaining compliance and advancing patient access to breakthrough therapies.
AI at the Forefront of Regulatory Dialogue
Artificial intelligence will take center stage this year, with multiple sessions exploring its role in transforming drug development, clinical research, and compliance operations. “AI is no longer a future topic—it’s actively reshaping product development,” said Amra Racic, VP of Global Government Strategy for MedTech at Veeva Systems.
Sessions such as “Embracing the Age of Generative AI in Drug Development” and “AI in Medical Devices: From Regulatory Frameworks to Global Market Readiness” will highlight how regulators and industry leaders are working to ensure that AI innovation is matched by strong ethical, safety, and compliance frameworks.
Committee member Francis Dekker, Director of Global Regulatory Affairs at Thermo Fisher Scientific, emphasized the importance of maintaining transparency and trust as technology advances: “As AI is an unstoppable force, it’s crucial for regulatory professionals to stay informed about regulatory developments and evaluate how they can use its potential to enhance their work.”
Building Trust, Equity, and Global Collaboration
Beyond technology, Convergence 2025 will tackle broader themes of diversity, global inclusion, and rebuilding trust in science. The opening plenary session focuses on restoring public confidence through empathy and transparent communication an increasingly important topic as science continues to outpace perception.
Several sessions will also examine how diversity in clinical trials can strengthen regulatory science and improve patient outcomes. As Tyler Vandivort, Associate Director of Regulatory Affairs at UCB Biopharma, noted, “Ensuring that clinical program participants mirror their intended patient populations is not only beneficial for all stakeholders—it’s good science.”
Practical Insights for Regulatory Leaders
From expedited development programs to China’s evolving drug approval pathways, the conference offers hands-on sessions designed to equip attendees with actionable strategies. “We’ll be talking about cutting-edge technologies that may really benefit our day-to-day work,” said Meng. “There are so many moving parts—our goal is to bring forward topics that make a real difference for professionals in the field.”
Committee members also encourage attendees to engage fully. “Be proactive,” Meng advised. “Make connections, raise questions, and share your ideas. Maybe those ideas will inspire new ones.”
EMMA International’s Perspective
At EMMA International, we understand that adaptability is key to regulatory success. As frameworks evolve and technologies like AI continue to redefine the industry, life science organizations must be ready to pivot without compromising compliance or quality.
Our team helps clients stay ahead by developing regulatory strategies that balance innovation with stability—whether it’s integrating AI tools, navigating multi-region submissions, or ensuring equitable access through global collaboration.
To thrive in times of uncertainty, the goal isn’t just to react—it’s to lead change with confidence, clarity, and purpose.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Mezher, M. (2025, October 6). Convergence 2025: Adapting to change and uncertainty in the regulatory landscape. Regulatory Affairs Professionals Society.
