Overview
Format
In person
Timing
7 AM - 4.30 PM EDT
Can AI Help Regulatory Teams Move Faster Without Compromising Regulatory Rigor?
Regulatory teams are under increasing pressure to manage growing data volumes, evolving global requirements, and demands for greater efficiency across product lifecycles. While AI is rapidly transforming regulatory affairs, the key question is no longer whether AI can support regulatory activities, but how it can be applied responsibly to deliver measurable value while maintaining quality, traceability, and regulatory-defensible outcomes.
At RAPS Convergence 2026, Celegence will share practical insights from real-world regulatory projects and discuss how AI-enabled solutions, combined with deep regulatory expertise, can help life sciences organizations improve regulatory operations without compromising regulatory rigor.
As an Innovator Sponsor, Celegence welcomes regulatory professionals, medical device manufacturers, pharmaceutical companies, and IVD organizations to connect with our team and explore the future of regulatory transformation.
Featured Session:
Can AI Actually Write a Defensible State of the Art? Lessons from Building AI for Regulatory Evidence Synthesis
Wednesday, September 16 | 11:55 AM–12:20 PM
Exhibit Hall – Spark! Theater, Booth #1100
Speaker:
Anushree Singh, Business Development Manager, Celegence
Generative AI has demonstrated impressive capabilities in summarizing literature and drafting content. However, developing a regulatory-defensible State of the Art (SOTA) section for a Clinical Evaluation Report (CER) requires far more than content generation. Evidence selection, duplicate publication management, traceability, synthesis across large datasets, expert interpretation, and regulatory judgement all influence whether the resulting output can support a defensible regulatory submission.
Drawing on lessons learned from developing AI-assisted approaches to regulatory evidence synthesis, this session will examine where AI can create meaningful efficiencies, where human expertise remains essential, and what a practical AI-assisted SOTA workflow looks like in real-world regulatory programmes.
What Attendees Will Learn
Attendees will gain insights into the unique challenges associated with AI-generated SOTA content, approaches for evaluating AI-assisted outputs for regulatory defensibility, areas where AI can improve efficiency, and where expert regulatory judgement remains indispensable. The session will also explore practical strategies for combining AI capabilities with regulatory expertise to enhance evidence synthesis workflows.
Meet the Celegence Team at Booth #800
Throughout RAPS Convergence 2026, the Celegence team will be available to discuss today’s most pressing regulatory and compliance challenges. Our experts bring extensive experience across regulatory strategy and transformation, medical device and IVD compliance, Clinical Evaluation Reports (CERs), State of the Art development, post-market surveillance, lifecycle management, regulatory operations optimization, AI-enabled regulatory workflows, and regulatory information and content management.
Whether your organization is navigating evolving global regulatory requirements, seeking to improve operational efficiency, strengthening clinical evaluation processes, or evaluating practical applications of AI within regulatory programmes, our team will be available to share insights drawn from real-world regulatory engagements.
- Lakshmeenarayana Goundalkar (LGG) – Chief Delivery Officer, Regulatory Services
- Sonia Veluchamy – Chief Executive Officer
- Punya Abbhi – Chief Operating Officer
- Cheryl Jessen – Chief Revenue Officer
- Meghan Mahoney – Director, Business Development
Connect With Celegence at RAPS Convergence 2026
Whether you are looking to improve regulatory efficiency, address complex compliance requirements, evaluate AI-enabled regulatory solutions, or access expert support for medical device, IVD, or pharmaceutical programmes, we would welcome the opportunity to connect.
Visit Booth #800 to meet Celegence’s regulatory, business, and technology leaders:
Attend our featured presentation, stop by our booth, or schedule time with our team to discuss how AI-enabled technology and regulatory expertise can help accelerate regulatory outcomes while maintaining the quality, traceability, and compliance required for success.
Dates: September 15–17, 2026
Location: Charlotte Convention Center
501 S College St, Charlotte, NC 28202, USA
Celegence Booth: #800
Participation: Innovator Sponsor
Event Website: RAPS US Convergence 2026
Registration: Register here
We look forward to connecting with you in Charlotte.
If you would like to schedule a meeting or connect with our team during the event, reach out to us at info@celegence.com. We look forward to connecting with you in Charlotte.