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Wednesday, June 26 • 4:15pm - 5:30pm
#383: Next-Generation Approaches for Developing Narratives

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-702-L04-P; CME 1.25; IACET 1.25; RN 1.25

This session will focus on automated approaches (content and process automation) for generating safety narratives.

Learning Objectives

Discuss automated approaches for generating safety narratives; Describe current challenges and future vision of automated approaches will be discussed in light of current technologies and requirements; Discuss strategies for soliciting feedback from health authorities on automated narratives.


Ulrike Kochendoerfer, PhD


Behavior, Process, and AI Driven Technologies: How They Work Together to Create a Streamlined Narrative Workflow
Justin Savesky

Narrative Writing: Organization and Automation
Mary McKenna, MS, MSc

FDA Perspective
Robert Ball, MD, MPH, MSc

avatar for Robert Ball

Robert Ball

Deputy Director, Office of Surveillance and Epidemiology, CDER, FDA
Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American... Read More →
avatar for Ulrike Kochendoerfer

Ulrike Kochendoerfer

Director, Medical Writing, Pfizer Inc
Dr. Ulrike Kochendoerfer has over 20 years of experience in pharmaceutical research. She started her career in pre-clinical research in toxicology and biochemistry, before entering the regulatory medical writing field in 2005. Dr. Kochendoerfer holds a PhD from the University of Bonn/Germany... Read More →

Mary McKenna

Head of Medical Writing, Business Ops and Svc, Merck & Co., Inc.
My early career was spent in statistical programming supporting clinical trials. That experience led to building and managing teams of statistical and data management programming groups for global pharmaceutical organizations and CROs. I transferred into Clinical Document Management... Read More →

Justin Savesky

Director, Regulatory Sciences Technology, Synchrogenix, A Certara Company
Justin Savesky, Director, Regulatory Science Technology has been immersed in the technology field for regulatory science for over eight years. As an employee of GlobalSubmit, he focused on the implementation and client management of systems for the Regulatory Operations community... Read More →

Wednesday June 26, 2019 4:15pm - 5:30pm
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  • Level Intermediate
  • Featured Topics Artificial Intelligence
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session