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Role of Medical Communications Experts in Building Accelerated Regulatory Dossiers and Securing First-Attempt Approvals
Session Chair(s)
Monica Chiaramonte, PhD
Director, Clinical Regulatory Writing
Astrazeneca Pharmaceuticals LP, United States
This Content Hub will discuss the role of medical communications experts in driving regulatory submissions and approvals, with focus on document strategy, authoring, review, quality control, and stakeholder management for accelerated submissions.
Learning Objective : Identify critical steps to accelerate the submission process; Formulate an effective communication strategy; Produce an effective storyboard; Complete a successful submission; Illustrate the fundamental role of a medical communications expert in delivering a successful submission.
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