Webinar – AI in Action: Tech-Empowerment in Medical and Technical Writing

What: Webinar in partnership with RAPS

When: Tuesday, June 3rd, 2025, from 11:00 AM to 12:00 PM Eastern Time (US & Canada)

Where: Online How: Register here

Why: Artificial intelligence (AI) is no longer a future concept for regulatory operations – it’s already transforming pharmaceutical and medical device regulatory writing today. In this webinar, learn how AI significantly reduces time, costs, and resource burdens associated with regulatory submissions.

Our expert speakers will explore real-world applications, share practical case studies, and present a live demonstration of AI tools in action. Gain actionable strategies to streamline submissions, improve accuracy and quality, and optimize your regulatory workflows.

All registrants will receive a recording of the webinar recording following the live event. Register now to secure your spot.

We’re partnering with RAPS to explore how the potential of AI in regulatory writing is already being realized across leading pharmaceutical and medical device organizations. This webcast will provide an in-depth look at how AI-driven solutions empower regulatory and clinical writing processes, driving faster, more efficient submissions without compromising quality.

Participants will see practical AI applications demonstrated live, hear real-world case studies, and learn strategies to successfully monitor, manage, and maximize AI outputs.

Insights from industry experts will help you identify opportunities to integrate AI into your organization’s regulatory writing practices, enhancing both operational efficiency and regulatory compliance.

Expect valuable discussions around:

• How AI accelerates regulatory submissions
• How to reduce manual workloads while improving consistency and quality
• What best practices to follow when implementing and monitoring AI-based outputs
• A case study and live demo illustrating real-world use

This session is a must-attend for organizations seeking to harness the full potential of AI in regulatory and technical writing.

Regulatory writing for pharmaceuticals and medical devices is increasingly burdened with demands for faster submissions, higher volumes of data, and tighter quality standards. AI offers a real-world solution to these pressures by streamlining drafting, editing, consistency checks, and information extraction, allowing regulatory professionals to focus on strategic value-add activities.

Understanding how to apply AI technologies now safely and effectively gives organizations a competitive edge in operational efficiency, compliance readiness, and cost management.

This webinar will help professionals move beyond the hype to practical applications that are already making a measurable difference in regulatory operations today.

• Jason Mattis, Head Global CMC Regulatory Affairs, Kenvue
  Jason brings over two decades of experience in CMC regulatory affairs, specializing in manufacturing, quality, and regulatory strategies for biologics, vaccines, and OTC products. His insights will provide valuable perspectives on implementing AI within regulatory operations.
• Punya Abbhi, Chief Operating Officer and Co-Founder, Celegence
  Punya focuses on tech-enabled services for life sciences, including the development of the AI-powered medical writing platform, CAPTIS®. Her leadership drives innovations that help pharmaceutical and medical device organizations enhance their regulatory efficiency and compliance strategies.
• Lakshmeenarayana Goundalkar, Chief Delivery Officer, Celegence
  With more than 18 years of expertise in software product development, regulatory delivery, and project management, LGG has successfully led regulatory services initiatives for over 30 global pharmaceutical, medical device, and biologics companies.

• Understand the practical role of AI in pharmaceutical and medical device regulatory writing.
• Identify key efficiencies AI offers across submission processes and data management.
• Gain real-world insights from case studies and live demonstrations.
• Learn strategies for monitoring, validating, and optimizing AI-driven outputs.

• Medical Device Manufacturers: VPs, Directors, and Senior Managers in Regulatory Affairs and Clinical Affairs interested in leveraging AI for compliance and operational efficiency.
• Pharmaceutical Manufacturers: Senior professionals in Regulatory Affairs and CMC seeking AI-driven solutions for lean authoring, publishing, and submission readiness.

Intermediate: Content is designed for professionals who already have foundational knowledge of regulatory affairs and are looking to advance their expertise with new, practical applications of AI technologies.