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Wednesday, June 30 • 10:00am - 11:00am
#314 SL: Lean Writing: Making Regulatory and Clinical Documents Simple and Straightforward

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Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-604-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

Describe lean writing approaches and end-to-end efficiencies in writing regulatory and clinical documents.


Yeshi Mikyas, PhD, RAC


Industry Update
Elizabeth Brown, MS, PMP

Industry Update
Concetta Marfella, PhD

Industry Update
Katharyn Spiegel, PhD

avatar for Yeshi Mikyas

Yeshi Mikyas

Senior Director, Medical Writing Lead for Clinical Documents, Oncology, Pfizer Inc, United States
Yeshi Mikyas, PhD has over 22 years’ experience in the clinical research space, including 16 years in Medical Writing in the pharmaceutical industry. Her experience in Medical Writing is both as an individual contributor and in leading teams throughout the spectrum of Medical Writing... Read More →
avatar for Elizabeth Brown

Elizabeth Brown

Principal Scientist/Managng Medical Writer, Merck & Co., Inc., United States
Elizabeth Brown is a Managing Medical Writer at Merck & Co near Philadelphia, PA. She has led regulatory projects and initiatives in the pharmaceutical industry for 20 years. First as a laboratory scientist, then a clinical researcher, and currently as a medical writer. Elizabeth... Read More →

Concetta Marfella

Head of Global Medical Writing Sciences, Vertex Pharmaceuticals, United States

Katharyn Spiegel

Global Regulatory Writing Senior Manager, Amgen Inc, United States

Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  04: MedAffairs-SciComm, Forum