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Monthly FDA Guidance and Regulatory News Review - September 2026
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Join Veristat and industry leaders in regulatory writing and submissions management to share and discuss the challenges of writing regulatory submissions in a continually changing regulatory environment. Regulatory submissions are becoming more complex and the guidelines, both US and global, regarding product data are more stringent than ever.
About the Conference
5th Annual Regulatory Writing for Product Approvals Conference
Dates: Wednesday, April 27- Thursday, April 28, 2016
Location: Wyndham Philadelphia Historic District 400 Arch Street, Philadelphia, PA 19016
Veristat Panel Discussion
EDITING CONSIDERATIONS FOR SUBMISSION DOCUMENTS
Discussion to be led by:
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, 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.