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Regulatory Submissions: Better, Faster, and Cheaper

Track:
Medical Communication, Medical Writing, and Medical Science Liaison

Day & Time:
June 16, 11:00AM - 12:30PM (Pacific Standard Time)

Session Number:
129

Room Number:
31AB

Level:
Intermediate

Type:
Symposium

Title:
Regulatory Submissions: Better, Faster, and Cheaper

Chair(s):
Nancy R. Katz, PhD
President and Principal Medical Writing Consultant
Illyria Consulting Group, Inc., United States

Description:
You can’t have it all, we are told, so pick two. This symposium provides strategies that enable medical writers to author high-quality clinical documents for a new drug application (NDA) or biologics license application (BLA), submitted on time and within budget. This symposium will also include the results of a survey on extra hours spent on tasks associated with CSR writing.

Learning Objective(s):
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.

Presentation(s) & Speaker(s):
Medical Writing Processes for New Drug Application Submissions: Real-World Case Studies
Anita Frijhoff, PhD
Senior Writer
Randstad Pharma, United States

Festina Lente (Make Haste Slowly): Time- and Cost-Effective eCTD-Based Drug Applications
Nancy R. Katz, PhD
President and Principal Medical Writing Consultant
Illyria Consulting Group, Inc., United States

Creating a More Effective Authoring Environment
Marijke H. Adams, PharmD, PhD
President and Principal Scientist
MH Adams & Associates, Inc., United States