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April 21, 2016

Don’t miss Paula Wun’s panel discussion on “Editing Considerations for Submission Documents” at the 5th Annual Regulatory Writing for Product Apporvals Conference.

 

Join Veristat and industry leaders in regulatory writing and submissions management at the upcoming 5th Annual Regulatory Writing for Product Approvals Conference to share and discuss the challenges of writing regulatory submissions in a continually changing regulatory environment.

Panel Discussion

On Thursday, April 28 at 10:40 AM, we invite you to join Paula Wun and an esteemed panel of industry experts will discuss the following:

EDITING CONSIDERATIONS
FOR SUBMISSION DOCUMENTS
Paula Wun, Senior Director, Medical Writing
Veristat

 

LEARNING OBJECTIVES

  • Avoiding edits to verbatim data from source materials
  • Designating a final authority decision maker
  • Editorial comment specificity
    • Clear text changes
    • Data edits vs. writing style comments
  • Develop editorial timelines for success
  • Reducing reviewer fatigue
  • Editorial checklist development
  • Integration of edits into final submission

PANEL EXPERTS INCLUDE:

  • Laura Sheppard, MBA, MA, Manager, Medical Writing, MALLINCKRODT PHARMACEUTICALS
  • Becky Nuttall, Medical Writing Lead, EMD SERONO
  • René Alvarez, Associate Director, Medical Writing, FIBROGEN
  • Gretchen Griffin, MS, Director, Regulatory Writing Strategic Solutions and Operations, ABBVIE
  • Leslie Lescale-Matys, Medical Writing Group Lead, SHIRE

We hope to see you at this exciting panel discussion.

Schedule a Meeting with Veristat

Veristat can offer you strategic guidance in planning for your regulatory submission, we provide representation at the agency meetings, and we provide the statistical as well as medical writing support to prepare the submission documents. We have over 20 years of experience helping clients prepare INDs, CTAs, NDAs, BLAs, and MAAs.

Schedule a time to speak with Paula or any of Veristat’s experts at the show about the challenges you are trying to overcome with your current or upcoming submission project.

Schedule Meeting