返回 Agenda
Submission Dossiers: Communications Excellence to Drive Speed and Quality
Session Chair(s)
Frank Hubbard, PHD, MS
President
Global Regulatory Writing Solutions Inc., United States
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 Objective : Define communications strategy linked to draft label; Discuss authoring strategies to maximize time to submission and approval from LSLV (last subject, last visit.)
Speaker(s)
Agreeing Submission Document Timelines 6 Months in Advance and Sticking to Them: Fairy Tale or Reality?
Steve Sibley, MS
Certara, United States
Vice President, Global Submissions and Submissions Leadership
It Is a Complex Team Sport to Prepare Global Simultaneous Submissions in an Alliance Project Team
Lei Cochran, MBA, MSC, PMP
Global Drug Development Consulting Group, LLC., United States
Managing Principal, Advisory Consultant
Regulatory Medical Writing Strategies for Accelerating Submissions
Kent Cochran, MS
GDDC Group, LLC, United States
Executive Director