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Session 2: From Design to Acceleration: Embedding Quality, Structure, and Agility
Session Chair(s)
Annie Jose
Associate Director, Medical Writing, GSK, Bengaluru, India
Session Overview: Accelerated and expedited regulatory pathways are changing how quickly teams must plan, write, review, and submit. In this session, we focus on how regulatory medical writers can help accelerate submissions—by building quality in early, using clear and consistent document structures, reusing content where appropriate, and working in an agile way when timelines are tight. The session talks about different accelerated pathways and what they mean for medical writers, including how to keep the story consistent across documents and how to prioritize writing and reviews without losing scientific or regulatory rigor. The session will close with a panel discussion and Q&A on how strong study design upfront can improve clarity, traceability, and overall submission readiness.
Speaker(s)
Shalini Dwivedi, MPHARM
VP, Krystelis Ltd, India
Panel Discussion with Q&A: Topic Faster, Smarter Regulatory Submissions: Building Quality from Protocol to Dossier Participating Panelist
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