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Regulatory Submissions: Better, Faster, and Cheaper
Session Chair(s)
Nancy Katz, PhD
Illyria Consulting Group, Inc., United States
Medical Writing Processes for New Drug Application Submissions: Real-World Case Studies
Learning Objective : Identify three challengess to the authoring of clinical regulatory submission documents; Describe at least two strategies for authoring multiple documents (eg, critical clinical study reports, Module 2 clinical summaries, and integrated summaries of efficacy and safety) in parallel while maintaining consistency across documents; Identify timeline challenges by clearly outlining accountabilities and expectations for all parties.
Speaker(s)
Medical Writing Processes for New Drug Application Submissions: Real-World Case Studies
Anita Frijhoff, PhD
Randstad Pharma, United States
Senior Writer
Festina Lente (Make Haste Slowly): Time- and Cost-Effective eCTD-Based Drug Applications
Nancy Katz, PhD
Illyria Consulting Group, Inc., United States
Creating a More Effective Authoring Environment
Marijke H. Adams, PharmD, PhD
MH Adams & Associates, Inc., United States
President and Principal Scientist
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