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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
Executive Director, Medical Writing & Disclosure
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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