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SUBMISSION CHALLENGES
Session Chair(s)
Nancy Tam, MS
Head of Medical Writing
Pfizer Inc, United States
Learning Objective : Understand how clinical data from studies in multiple indications can be used to support marketing approval in an initial lead indication. Understand alternative strategies for presenting clinical data from studies in multiple indications in a marketing application. Understand the use of integrated analyses across multiple indications.
Speaker(s)
Keeping Your CSRs Global in the Face of Regional Requirements
Helena I Ryer, PhD
Sanofi Pasteur, United States
Senior Director, Medical Writing & Translation
Mastering Data From Multiple Indications in Marketing Applications
Nancy Tam, MS
Pfizer Inc, United States
Head of Medical Writing
Managing the medical writing process for responding to eCTD questions in the EU
Douglas Fiebig, PhD
Trilogy Writing & Consulting, Germany
Senior Partner
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