Sponsored Webcast: Beyond Submission Assembly: Managing the Full Regulatory Review Lifecycle (On Demand)
Regulatory submissions have evolved from static dossiers into dynamic, multi-stage programs that must remain coherent and defensible throughout development and review. Regulatory teams are increasingly challenged to maintain consistency, traceability, and alignment across submission content as data changes, reviews progress, and questions arise.
In this webinar, Brandon Rice, CEO of Weave, will lead a discussion on how regulatory teams can better support the full submission lifecycle—from assembling and maintaining submission content to managing change and follow-up during health authority review. He will be joined by Tala Fakhouri, vice president of regulatory consulting for AI & Digital Policy and Real-World Research at Parexel, who brings a former FDA regulatory policy perspective on how submissions are assessed over time and where teams most often encounter friction. Drawing on her experience at the FDA, Tala will discuss how reviewers engage with submissions beyond initial receipt, including how clarity, structure, and traceability can influence review efficiency and confidence. She will highlight common challenges reviewers face when submission content is fragmented or difficult to navigate, and what distinguishes submissions that support a smoother review process.
Brandon will then explore how integrated regulatory platforms, such as Weave, are being used to support submission development and evolution—helping teams build submissions more efficiently, maintain alignment across documents, and respond to review feedback without rework or loss of context. The session will illustrate how treating submissions as living assets can improve coordination, reduce operational strain, and support more effective regulatory interactions. This webinar is designed for regulatory professionals seeking a practical, reviewer-informed perspective on managing submissions across their full lifecycle.
Learning Objectives
- Describe how health authorities engage with regulatory submissions throughout the review lifecycle, from initial receipt through follow-up and response.
- Identify common sources of friction in regulatory submissions, including challenges related to structure, traceability, and cross-document alignment.
- Evaluate approaches for supporting submission development and evolution, including strategies for maintaining consistency and clarity as submissions change over time.
- Recognize how integrated regulatory workflows can support more effective collaboration and response preparation during health authority review.
Who Should Attend?
Designed for regulatory affairs and operations professionals responsible for building, maintaining, and responding to regulatory submissions across the review lifecycle.
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.
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 [email protected].
Speakers
Brandon Rice
Tala Fakhouri
