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It’s All Part of the Plan: Preparation and Planning for a Series of Submissions
Session Chair(s)
Ann Winter-Vann, PhD
Senior Writer and Manager
Whitsell Innovations, Inc., United States
When you are faced with a staggered series of submissions to different regulatory agencies or simultaneous submissions for different indications or both, the challenges increase exponentially. We will discuss how to plan for consistency with the careful reuse and revision of text between documents and across a team of writers. We will also present strategies to map out timelines that are feasible and keep team members involved but not exhausted.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Assess the challenges involved in sequential submissions
- Employ best practices for the reuse and revision of text across related documents
- Construct timelines for a staggered series of submissions
Speaker(s)
Speaker
Lima Chutkan, PhD, RAC
Alnylam Pharmaceuticals, United States
Associate Director, Medical Writing
Multiple Indications, Line Extensions and Formulation Changes
Kirsten Helmcke, PhD, RAC
Astellas Pharma Global Development, United States
Associate Medical Writing Program Director