RAPS Convergence 2026: Regulatory work in a changing world

RAPS Convergence 2026: Regulatory work in a changing world 

At RAPS Convergence in Charlotte, our LexisNexis Life Sciences Solutions team joined regulatory professionals to explore how technology, global requirements, and new sources of evidence are changing their work. We were proud to sponsor the event and hear perspectives from across the industry.

AI brings opportunity—and a need for judgment

Artificial intelligence was a recurring topic in sessions and conversations. Former FDA Commissioner Robert Califf described the need for regulatory approaches to keep pace with products and data that evolve over time. Speakers also emphasized that, as tools change, regulatory professionals still need to think critically, evaluate evidence, and protect patients. 

Matt Jaffe, General Manager of LexisNexis Life Sciences Solutions, saw that balance throughout the week: 

“Harnessing it in a safe and compliant manner is the key aspect of getting it right in a regulated environment, forcing balance between speed of progress and quality of execution.” 

For our team, the discussions raised practical questions about how AI could support regulatory intelligence, product registrations, and ongoing compliance.

Global requirements continue to evolve 

A panel on proposed reforms to the EU Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) explored ways to make oversight more predictable and proportionate to risk while maintaining patient safety. Proposed changes include more structured dialogue with notified bodies and changes to some review and recertification requirements. The reforms remain under consideration. 

The discussion also highlighted the value of connected regulatory data. Notified body representatives described how access to EUDAMED registration, certificate, and vigilance information could help them identify risks and target oversight more effectively. 

Across other sessions, speakers pointed to differences in how regions apply regulatory standards. For teams managing global portfolios, those differences make early planning and communication across regulatory and commercial teams increasingly important.

Different products call for different perspectives 

The breadth of the program was a reminder that regulatory decisions often reach beyond a product’s immediate use. Mary Frasch, Senior Regulatory Consultant, was struck by a session on animal drug approvals: 

“For animal health products used in food-producing animals, CVM must also consider human food safety, including potential residues in meat, milk, and eggs, as well as the potential environmental impact.” 

Her takeaway captured a theme that ran through the conference: good regulatory decisions depend on understanding the full context of a product, its data, and the people it may affect. 

We left Convergence with new ideas and valuable conversations about how to help life sciences companies manage requirements across products and markets. As Matt put it, our team came back “energised about the potential” to connect capabilities and help manufacturers manage compliance more effectively.

Turn regulatory complexity into a clearer path forward 

From pharmaceutical labeling and submissions to medical device UDI, cosmetics listing, data management, and U.S. Agent services, LexisNexis Life Sciences Solutions helps teams manage requirements across the product lifecycle. 

Explore our life sciences solutions or contact our team to discuss your regulatory priorities.