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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)
Elizabeth Brown, MS, PMP
Executive Director, Clinical & Regulatory Strategic Communications, Merck & Co., Inc., United States
Industry Update
Concetta Marfella, PHD
Head of Global Medical Writing Sciences, Vertex Pharmaceuticals, United States
Industry Update
Katharyn Spiegel, PHD
Global Regulatory Writing Senior Manager, Amgen Inc, United States
Industry Update
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