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Can Topic-Based Approaches to Document Authoring Help Meet the Demands of Accelerated Marketing Application Timelines?
Session Chair(s)
Frank Hubbard, PhD, MS
President
Global Regulatory Writing Solutions Inc., United States
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 Objective : 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.
Speaker(s)
What is Topic-Based Authoring and What is the Problem we are Solving For?
Frank Hubbard, PhD, MS
Global Regulatory Writing Solutions Inc., United States
President
Accelerated Delivery of Efficacy and Safety CTD Components Using Topic-Based Authoring Strategies
Mary Jean Matus
Audubon PM Associates, United States
Consultant, Medical Writer
Topic-Based Authoring: Clinical Pharmacology Components of BLA/NDA Submissions
Lisa Iacono Sheehan, PharmD
Bristol-Myers Squibb, United States
Director Global Regulatory Strategy
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