Convergence 2025: Adapting to change and uncertainty in the regulatory landscape

Regulatory professionals must navigate change and uncertainty amid an evolving global regulatory landscape, new technologies such as artificial intelligence (AI), and the rapid pace of scientific advancement. This year’s RAPS Convergence will feature insights from regulators and industry experts to help attendees stay ahead of the curve and deliver innovative healthcare products to patients.

“This year, really, it’s a lot of uncertainties,” said Michelle Meng, VP, Head of Global Regulatory Sciences, OBI Pharma, and a member of the 2025 Convergence Committee.

“Every year, we are always focusing on that new information, that innovation piece – what’s really new, what’s going on in the industry. This year, particularly, I think it’s going to be very helpful because of all the new changes in our industry and this entire regulatory environment. This is a place we can just freelance exchange our information and ideas,” Meng said.

There are “so many moving parts,” she added, explaining that one of the committee’s challenges is to identify how topics and future trends to tackle during sessions to “make a difference and a positive impact” for attendees.

RAPS Convergence will be held 7-9 October at the David L. Lawrence Convention Center in Pittsburgh.

Session highlights

“For me, this year’s sessions really highlight the power and importance of communication in regulatory affairs and beyond,” said Tyler Vandivort, associate director, regulatory affairs lead at UCB Biopharma, who also serves on the Convergence Committee.

At the opening plenary on 7 October, experts from across industry and academia will address rebuilding trust in science – a timely topic as scientific advancement often outpaces public trust – through transparent communication and empathy.

“There are a number of presentations addressing AI from various perspectives, including its impact on healthcare products and compliance, as well as its use as a tool for regulatory professionals. As AI is an unstoppable force, it is crucial for regulatory affairs professionals to stay knowledgeable about the regulatory developments in this area and to evaluate how they can use its potential to enhance their work,” said Convergence Committee member Francis Dekker, director, global regulatory affairs, microbiology, at Thermo Fisher Scientific.

Amra Racic, vice president, global government strategy, medtech, at Veeva Systems, who also serves on the Convergence Committee, advised attendees that “AI is no longer a future topic—it’s actively reshaping product development. The focus is on creating regulatory frameworks that foster AI-driven innovation.”

On Wednesday, sessions focused on AI include “Embracing the Age of Generative AI in Drug Development,” “Decoding and Understanding Artificial Intelligence (AI) - EU AI implementation,” and “AI in Medical Devices: From Regulatory Frameworks to Global Market Readiness.” Two sessions on Thursday will address the technology: “Accelerating Postmarket Innovation with Predetermined Change Control Plans (PCCPs): AI/ML and Beyond,” and “Can GenAI Help Regulatory Teams Scale Up Their Operations? Pitfalls and Best Practices.”

Vandivort encouraged attendees to join the session, “Enhancing Understanding of Biologic Variability Through Representation in Clinical Trials,” Wednesday morning. “Ensuring that clinical program participants mirror their intended patient populations is not only beneficial for all stakeholders, but it is also good science! While there is still uncertainty surrounding the fate of the Diversity Action Plan guidance in the US, numerous other health authorities have affirmed that such plans represent the future of our field,” he said.

Wednesday will also feature a plenary session focused on bridging access gaps to deliver equitable innovation to patients. Racic, who is moderating the session, said the session will “tackle the critical challenge of bridging access gaps and ensuring patients worldwide have equal access to life-changing innovations,” with a focus on the role regulatory affairs plays in the healthcare ecosystem.

“I would like to highlight the plenary session on Thursday, which is about a patient’s journey and the health award for the Michael J. Fox Foundation for Parkinson’s Research. The health reward is particularly meaningful for me as several people I know suffer from Parkinson from a relatively young age, so I understand the critical importance of further research. Ultimately, our work as regulatory professionals is for the patient, helping to ensure they can receive the best possible care!” Dekker said.

“There will be a lot,” for attendees to take in, said Meng. “We will be talking about different tools and all the cutting-edge technologies that may really benefit our day-to-day work, and we’re also going to have so many sessions on the different regulatory pathways, [including] sessions on expedited pathways and a lot of discussions on how we can speed up drug development, not just in the US and Europe, but also in other countries as well.”

Meng pointed to two sessions she’s particular excited about. Wednesday’s session, “Expedited Programs to Support the Development and Approval of Products for Unmet Medical Needs,” will feature “discussion from industry leaders and the health authorities about programs that can help accelerate development.” The session “China Drug Regulatory Pathways: 2025 Current Landscape & Global Integration Perspectives” on Thursday will help attendees learn “how to incorporate China into global development.”

Advice for attendees

“I would say, be proactive,” Meng said. “We’re going to a conference not just to sit there and listen, right? If you really want to get the most out of it … be proactive and reach out. Make the connections and raise questions during the discussion and share your ideas. Maybe those ideas will inspire new ones.”

Vandivort urged first-time attendees to check out the Convergence event app. “I’ve found the RAPS app to be particularly valuable in previous years for setting your schedule, for getting presenter slides and bios, and for taking notes, and this year is no exception,” he said. Vandivort also stressed that attendees should “embrace the awkward and learn to dive in” to make lasting connections with other attendees from around the world. “There are lots of good reasons to attend Convergence, but the value inherent in making and maintaining connections with global regulatory colleagues is hard to get anywhere else.”

“I always enjoy the midday Exhibit Hall hours. These hours offer excellent networking opportunities. For instance, at the Solutions Circles, you can discuss a topic more in-depth with those who share you interests,” said Dekker.

2025 RAPS Convergence

Convergence 2025: Adapting to change and uncertainty in the regulatory landscape

Related topics

Recommended content

Welcome to the new RAPS Digital Experience