In today's increasingly complex regulatory environment, the pressure to accelerate global submissions while maintaining the highest quality standards has never been greater. A successful submission is not merely a collection of documents: it is a meticulously constructed, interconnected dossier that must be clear, navigable, and compliant with diverse health authority (HA) technical requirements. All too often, a functional divide between regulatory writing and regulatory operations teams creates significant challenges, leading to last-minute fire drills, costly rework, and potential submission delays. Common pain points include misaligned content plans, incorrect document referencing, broken hyperlinks, and eleventh-hour scrambles to accommodate regional differences.
This presentation will detail a proactive, integrated model for "building a bridge" between regulatory writing and operations. Drawing from real-world case studies, we will explore the tangible benefits of early and continuous collaboration. We will discuss practical strategies for establishing shared submission standards, developing a robust hyperlink strategy, and planning for global submissions from the outset. By treating the submission process as an integrated partnership rather than a linear hand-off, organizations can significantly improve efficiency, reduce risk, and ultimately accelerate the delivery of high-quality, reviewer-friendly submissions.
Learning Objectives
- Develop effective collaboration strategies between regulatory writing and operations to ensure seamless alignment of content with eCTD structure.
- Identify key differences between major HAs and develop a plan to address them proactively during the authoring phase.
- Apply best practices for hyperlinking and document referencing to create clear, compliant, and easily navigable regulatory submissions.
Who Should Attend?
- Regulatory Affairs Professionals (especially those managing global submissions)
- Regulatory Writers and Medical Writers
- Regulatory Operations / eCTD Publishing teams
- Submission Managers and Project Managers in pharma/biotech
- Clinical Documentation or Submission Readiness leads
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.
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
Evan Richardson
