Event Description: As CTIS implementation advances and expectations for plain language summary (PLS) continue to evolve, regulatory teams are under increasing pressure to deliver accessible, high-quality content on tighter timelines and across multiple languages. Traditional, document centric workflows often introduce delays, inconsistencies, and rework—challenges that become more pronounced as transparency requirements expand. At the same time, both sponsors and regulators are shifting toward more iterative, real- time approaches to review and assessment.
This webinar explores a practical operating model for scaling PLS development using governed AI and Agile-informed workflows where AI agents orchestrate drafting, review, and revision tasks within defined governance controls. Attendees will learn how structured templates, source anchored drafting, readability targets, and human-in-the-loop quality control can be combined to reduce manual effort (reduce cycle times and rework) while maintaining clarity, traceability, and regulatory confidence. The session concludes with a live AgileWriter® demonstration showing how AI-enabled workflows facilitate iterative drafting, review, and localization of PLS content aligned with CTIS timelines and provide a scalable blueprint for modernizing PLS operations in an increasingly transparent regulatory environment.
Registration Fees & Deadlines
Free
Learning Objectives
- Explain how evolving CTIS and PLS expectations are driving a shift toward more iterative, real time regulatory workflows
- Identify common bottlenecks in manual PLS development and how governed AI can help address them
- Apply practical, human in the loop approaches to improve consistency, accessibility, and review efficiency at scale
Who Should Attend?
- Regulatory affairs professionals involved in clinical trial transparency and disclosures
- Medical writers and publication professionals supporting plain language summaries
- Clinical operations and transparency teams working with CTIS
- Quality, governance, and digital transformation leaders evaluating AI enabled workflows
Audience Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Jason Casavant
Chief Innovation Officer, Synterex Inc.
Jason Casavant is the chief innovation officer at Synterex, Inc. Over his 25+ years of experience in the life sciences and clinical research industry, Jason has brought a passion for innovation and technology to his leadership of medical writing, GCP quality assurance, operations, and training teams. This breadth of expertise reflects a strong foundation in both technical and leadership domains, allowing him to drive compliance and operational excellence across complex projects. In addition to technical expertise, he has contributed thought leadership through presentations and discussions on topics such as motivation, engagement, and agile methodologies in regulated environments, emphasizing continuous improvement and adaptive project management practices.
Pallabi De
Senior Director, Medical Writing Technology and Content Architecture, Synterex Inc.
Pallabi De is a seasoned medical writing professional with over 15 years of experience in regulatory documentation across multiple therapeutic areas. Pallabi has led numerous IND and NDA submissions and is an expert in clinical trial transparency and disclosure. Known for streamlining document management and driving process improvements, she has successfully led high-performing medical writing teams. As senior director of medical writing technology and content architecture at Synterex, Pallabi is leading the integration of AI and advanced technologies into medical writing. She also serves on the AMWA AI Task Force.
Elizabeth Patterson
Medical Writing Associate, Synterex Inc.
Elizabeth Patterson is a medical writing associate with a background in nonclinical oncology research. She spent her first years at Synterex on the operations team where she gained valuable customer-facing experience across the business, sales, and marketing sectors. In her current role, Elizabeth applies her integrated experience to support the backend development of AgileWriter.
Sahishnu Patel
Associate Director of AI and Automation R&D, Synterex Inc.
Sahishnu Patel, Ph.D., is the associate director of AI and automation R&D at Synterex, where he contributes to identifying emerging innovative platforms and advancing responsible AI practices. Before joining Synterex, Sahishnu spent several years at Amgen as a regulatory and medical writing leader, managing global submission strategy across oncology programs and authoring key submission and publication documents. Earlier in his career, he worked across medical devices and biotech, and supported start-up innovation through the NSF I-Corps program for the NanoScript platform he developed during his doctoral research.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
support@raps.org.