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Thursday, June 18 • 5:00pm - 6:00pm
#513 OD: ON DEMAND - Templates That Do More: How We Are Accelerating Drug Development via Structured Content Reuse

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Component Type: Session
Level: Intermediate

This session explores the emerging digitization of medical regulatory documents templates. With these templates structure dictates for improved quality, comprehension, reuse, and enabling technology for speed and quality.

Learning Objectives

Discuss the benefits of smart templates and how they enable content for multiple uses; Describe the impact on speed when intelligence and digitation are applied to the templates; Compare and contrast traditional narrative driven templates vs. the need for speed and digitization.

Chair

Mitzi Allred, PhD

Speaker

Templates That Do More: A Story Told With the NIH eProtocol Tool
Alyssa Tonsing-Carter, PhD

Accelerating Drug Development via Structured Content Reuse: Introducing eTemplates
Vivian Combs, MS

Templates That Do More: Why Structured Documents Matter! A Story Told With eTemplates
Mitzi Allred, PhD

Industry Update
TK Booker Porter, PhD



Speakers
avatar for Mitzi Allred

Mitzi Allred

Director, Clinical Operations, Merck & Co., Inc., United States
Mitzi Allred is a Director at MSD where her focus is on Structured Content Management. She has over 20 years of experience in the biopharmaceutical industry in Regulatory & Clinical Operations. Mitzi uses process improvement through information design and structured content reuse... Read More →
VC

Vivian Combs

Advisor/Process Owner, Clinical Systems and Supply Planning, Eli Lilly and Company
Vivian Combs currently leads the TransCelerate workstream responsible for the development of the TransCelerate Clinical Template Suite. She is the rapporteur for the ICH M11 CESHarP (Clinical Electronic Structured Harmonized Protocol) Expert Working Group, and is a full-time Process... Read More →
AT

Alyssa Tonsing-Carter

Office of Science Policy, National Institutes of Health (NIH)
Alyssa Tonsing-Carter, PhD is a Health Science Policy Analyst at the National Institutes of Health (NIH), Office of the Director, Office of Science Policy. She works on a range of clinical trials policy issues within the Division of Clinical and Healthcare Research Policy including... Read More →
avatar for TK Booker Porter

TK Booker Porter

Senior Director, Global Medical Writing and Regulatory Operations, Greenwich BioSciences, United States
T.K. Booker Porter leads global medical writing at Greenwich Biosciences/GW Pharma. She is passionate about continuous improvement in an environment that is ever-changing due to shifting global regulatory requirements, trends with patient input, and advances in technology. She has... Read More →


Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044