Celegence at RAPS US Convergence 2025

Event Dates: Tuesday, October 7 – Thursday, October 9, 2025
Location: David L. Lawrence Convention Center, Pittsburgh, Pennsylvania, USA
Booth: 329
Event Website: RAPS Convergence 2025
Registration: Register here

RAPS US Convergence 2025 is one of the most anticipated events for regulatory professionals worldwide, bringing together industry experts, regulators, and innovators to discuss the latest challenges and advancements in life sciences regulations. Celegence is proud to once again be premier sponsor of the event, where we’ll showcase our latest AI-enabled solutions and share insights for regulatory compliance in both the pharmaceutical and medical device industries.

Where to Find Us

Visit Celegence at booth #329 to experience AI in action

Stop by to explore how our AI-powered regulatory solutions are driving efficiency, accuracy, and compliance. While you’re there, you’ll get the chance to:

• See a live demonstration of our AI-assisted tools for Clinical Evaluation Reports (CERs)
• Take part in our quiz for a chance to win a $100 Amazon voucher
• Chat with our regulatory subject matter experts and get practical insights
• Enjoy a free coffee on Wednesday morning – our treat!
• Pick up exclusive giveaways and helpful educational materials

Don’t Miss Our Sponsored Session: AI for Compliant CER Reports

• Presentation Title: AI for EU MDR-Compliant Clinical Evaluation Reports: Tools, Tactics, and Compliance Insights
• Date & Time: Wednesday, October 8, 2025 | 10:45 AM – 11:10 AM ET
• Presenter: Shruti Sharma, Technical Account Manager, Celegence

The EU MDR imposes heightened expectations for Clinical Evaluation Reports, requiring detailed evidence, robust traceability, and ongoing updates throughout a device’s lifecycle. Our session will explore the evolving role of AI in supporting these requirements through smarter literature review, data extraction, and report authoring.

Session Highlights:

• Explore how AI tools enhance efficiency without compromising quality or compliance
• Discover the best-suited CER tasks for automation, including literature screening and PMCF planning
• Gain awareness of regulatory expectations and constraints around AI implementation
• Learn best practices for integrating AI insights into your human-led regulatory quality systems
• Review practical case studies demonstrating real-world use of AI in CER generation

Learning Objectives:

• Understand how AI supports the clinical evaluation process under EU MDR
• Identify AI-appropriate tasks in CER creation
• Assess regulatory risks and compliance considerations related to AI
• Apply integration strategies for AI outputs within quality systems
• Analyze real-world examples, including PMCF workflows

Meet the Celegence Team

Our expert team attending RAPS US Convergence 2025 includes:

• Sonia Veluchamy – CEO
• Lakshmeenarayana Goundalkar (LGG) – Chief Delivery Officer, Regulatory Services
• Meghan Clark – Business Development Manager
• Erin Cosgrove – VP, Business Development – Medical Devices
• Shruti Sharma – Technical Account Manager
• Asya Agres – Senior Marketing Director

We welcome you to stop by Booth #329 to connect with our team and learn how Celegence can support your regulatory needs through tailored consulting, medical writing services, and tech-enabled solutions like CAPTIS^® and Dossplorer™.

Let’s Talk Regulatory Innovation

Whether you’re facing EU MDR compliance challenges, preparing for global submissions, or simply looking for ways to optimize regulatory efficiency through automation, Celegence is here to help. Let’s have a conversation at RAPS US Convergence 2025.

Register now to attend and make sure to add our session to your agenda.

Contact us for more information: info@celegence.com.