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Monday, June 19 • 11:00am - 12:15pm
#109: Submission Dossiers: Communications Excellence to Drive Speed and Quality

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Component Type: Session
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

Pharmaceutical companies are driving the 'time to submission' paradigm in today's market pressured by submitting dossiers to multiple markets in the same time period, as quickly as possible following last database lock of pivotal studies. In turn cross-functional teams are looking for strategies/approaches to realize a quicker yet just as effective submissions. This session will explore optimal authoring approaches to plan, execute, and deliver marketing applications to time and quality. Case studies will provide cross-disciplinary views to highlight successful approaches and best communications practice.

Join Medical Writing Community for a follow up Round Table discussion at 1:45pm in the Community Corner.

Learning Objectives

Define communications strategy linked to draft label; Discuss authoring strategies to maximize time to submission and approval from LSLV (last subject, last visit.)

Chair

Frank Hubbard, PhD

Speaker

Agreeing Submission Document Timelines 6 Months in Advance and Sticking to Them: Fairy Tale or Reality?
Steve Sibley, MS

It Is a Complex Team Sport to Prepare Global Simultaneous Submissions in an Alliance Project Team
Lei C Chuang, MSc

Regulatory Medical Writing Strategies for Accelerating Submissions
Kent Cochran, III, MS



Moderators
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, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my pr... Read More →

Speakers
LC

Lei Chuang

Advisory Consultant, Global Drug Development Consulting
Lei is an experienced Project Management Professional (PMP) with 20+ years of global drug development project and program management experience for small, large, and hybrid (bio)pharmaceutical companies. With a track record of employing integrative project management practice and... Read More →
KC

Kent Cochran

Director, Janssen Pharmaceutical Companies of Johnson & Johnson
A medical writer and manager for 20+ years, Kent has worked in multiple therapeutic areas (mainly Oncology) in small and large global companies, including Wyeth, Centocor, and Johnson & Johnson. He has successfully managed the writing activities for multiple global submissions. H... Read More →
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, I founded Global Regulatory Writing Solutions Inc. in late 2013. GRW Solutions provides regulatory submission advice and Communications best practice to the pharmaceutical industry. Given my pr... Read More →
SS

Steve Sibley

Vice President, Global Submissions and Submissions Leadership, Synchrogenix, a Certara Company
With a career spanning more than 25 years in the pharmaceutical industry, Mr. Sibley has extensive regulatory writing experience across Modules 1-5, with project and team leadership roles on more than 50 submissions. His experience is truly global, having worked in project teams... Read More →


Monday June 19, 2017 11:00am - 12:15pm
S503ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616