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Medical Affairs and Scientific Communications Forum
Session 4: General Session: Emergency Use Authorizations (EUA) Panel DIscussion
- Senior Director, Head of Medical Writing
- Moderna, United States
Karen Joyce Hager, MS
- Director, Clinical Trial Management, Global Clinical Operations
- Vertex Pharmaceuticals, United States
The panel will take questions about the EUA submission process and share lessons learned and recommendations for agile submission practices with the audience. There will be emphasis on impact on Medical Writing function.
Learning Objective : At the conclusion of this session, participants should be able to:
- Discuss tips for optimizing the submission timeline and determine when to escalate
- Identify one or more tips for clear effective communication to facilitate the progress the submission timeline
- Define roles and responsibilities of the submission team (i.e. RACI use)
Preconference Short Courses
Medical Communications Primer: The Fundamentals of Medical Communications
Short Course #1: Medical Communications: Compliance in 2022
Short Course #2: Advertising and Promotional Content Review: The Role of Medical Information
Short Course #3: Statistics for Non-Statisticians
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