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

Sign up or log in to save this to your schedule, view media, leave feedback and see who's attending!

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.)


Frank Hubbard, PhD


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

avatar for Frank Hubbard

Frank Hubbard

President, Global Regulatory Writing Solutions Inc., United States
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 →


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 →

Kent Cochran

Director, Regulatory Medical Writing, 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. His group supports clinical development projects in both early and late development. He... Read More →
avatar for Steve Sibley

Steve Sibley

Vice President, Global Submissions and Submission Leadership, Certara Synchrogenix, United States
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles. He has successfully supported projects from discovery through approval and life cycle management... Read More →

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