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Consistency Within and Across Regulatory Documents: Writing and Managing

Level:
Foundation
Area:
Drug Development
Code:
DDF48
Duration:
03:00:00
Workshop profile:
This workshop is intended for writers who have basic experience in regulatory medical writing (RMW) and an interest in document consistency and project management. Writers without previous RMW experience could also benefit from this workshop after completing two additional pre‑workshop requirements.
Objective:
This workshop aims to demonstrate what consistency is, how writers can recognize and avoid inconsistencies, and tips for project management in large-team submission projects. Following this workshop, participants should be able to recognize the different types of consistency, identify inconsistencies and avoid/correct them, and manage demanding submission projects with more confidence and competence.
Content:
The workshop will give good and bad examples of document consistency and demonstrate how writers can recognize and avoid/correct inconsistencies when writing or updating documents; present advice for improving inter‑ and intra‑document consistency; use examples from submission projects to explain strategies for consistent complex documents; provide project management tips to help face the challenges of working in large teams of writers and reviewers; and provide tips for better team communication under time pressure.