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Wednesday, June 26 • 8:00am - 9:15am
#307: Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-648-L04-P; CME 1.25; IACET 1.25; RN 1.25

Use of multiple sub-teams, each focused on a topic (eg, safety, efficacy) and responsible for delivering content across multiple documents, can accelerate the delivery of marketing applications. Pros and cons of such approaches will be discussed. Join the Medical Writing Community for a follow up Round Table discussion on Wednesday, June 26, 2:00-3:00PM in the DIA Community Zone 1, Sails Pavilion.

Learning Objectives

Describe the basic concepts of a topic-based approach to delivering marketing applications; Identify potential pros and cons of topic-based approaches in order to identify where such approaches may or may not be appropriate to marketing applications in the attendee’s own organization.


Frank Hubbard, PhD, MS


What is Topic-Based Authoring and What is the Problem we are Solving For?
Frank Hubbard, PhD, MS

Accelerated Delivery of Efficacy and Safety CTD Components Using Topic-Based Authoring Strategies
Mary Jean Matus

Topic-Based Authoring: Clinical Pharmacology Components of BLA/NDA Submissions
Lisa Iacono Sheehan, PharmD

avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc.
Following a 14-year career in the Medical Communications Science group at AstraZeneca, Frank founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. From 2015... Read More →

Mary Jean Matus

Consultant, Medical Writer, Audubon PM Associates
Mary Jean Matus is a medical writer with Audubon PM Associates, Inc., a niche CRO specializing in regulatory documents and submissions in markets around the world. Mary Jean has 25 years of quality assurance and medical writing experience across a broad range of therapeutic areas... Read More →
avatar for Lisa Iacono Sheehan

Lisa Iacono Sheehan

Director Global Regulatory Strategy, Bristol-Myers Squibb
Lisa has been at Bristol-Myers Squibb for 15 years. Her first 10 + years was spent in Clinical Pharmacology where she ran clinical pharmacology studies and provided support for oncology and metabolic drug development. For 4 years, Lisa has been a Documentation Lead supporting Clinical... Read More →

Wednesday June 26, 2019 8:00am - 9:15am PDT
Room 4 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session