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Virtual Event

May 06, 2020 10:00 AM - May 07, 2020 4:45 PM

(Eastern Standard Time)

Fort Washington, PA 19034

Medical Affairs and Scientific Communications Forum

It’s All Part of the Plan: Preparation and Planning for a Series of Submissions

Session Chair(s)

Ann  Winter-Vann, PhD

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)

Lima  Chutkan, PhD, RAC

Speaker

Lima Chutkan, PhD, RAC

Alnylam Pharmaceuticals, United States

Associate Director, Medical Writing

Kirsten  Helmcke, PhD, RAC

Multiple Indications, Line Extensions and Formulation Changes

Kirsten Helmcke, PhD, RAC

Astellas Pharma Global Development, United States

Associate Medical Writing Program Director

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