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Lean Writing: Making Regulatory and Clinical Documents Simple and Straightforward
Session Chair(s)
Yeshi Mikyas, PhD, RAC
TransCelerate Lead; Senior Director, Medical Regulatory Writing and TA Lead
Pfizer Inc, United States
This session includes a discussion of end-to-end efficiencies that can be implemented in writing regulatory and clinical documents, using the CSR as a case study.
Learning Objective : Describe lean writing approaches and end-to-end efficiencies in writing regulatory and clinical documents.
Speaker(s)
Industry Update
Elizabeth Brown, MS, PMP
Merck & Co., Inc., United States
Senior Director, Medical Writing
Industry Update
Concetta Marfella, PhD
Vertex Pharmaceuticals, United States
Head of Global Medical Writing Sciences
Industry Update
Katharyn Spiegel, PhD
Amgen Inc, United States
Global Regulatory Writing Senior Manager
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