webinar Ensuring Writing Quality in eCTD Modules 2.4 and 2.5: Best Practices

Ensuring Writing Quality in eCTD Modules 2.4 and 2.5: Best Practices

Speakers:


Dr. Srinivas Shenoy Badathody Vice President, Medical & Scientific Affairs Navitas Life Sciences	Ankurkumar Joshi Senior Manager Medical Writing Navitas Life Sciences

Writing high-quality overviews and summaries in eCTD Modules 2.4 and 2.5 is critical to facilitating efficient regulatory review and supporting successful submissions. Join our regulatory experts as they share practical strategies, industry best practices, and key considerations for developing clear, compliant, and scientifically robust documentation.

Webinar Overview
This session will explore the fundamentals of eCTD Module 2 documentation and provide actionable guidance for enhancing writing quality within Modules 2.4 (Nonclinical Overview) and 2.5 (Clinical Overview).

Key Discussion Topics

Overview of eCTD and Modules 2.4 & 2.5
Key Principles of High-Quality Writing in Modules 2.4 & 2.5/span>
Best Practices for Writing Nonclinical Overview (Module 2.4)
Best Practices for Writing Clinical Overview (Module 2.5)
Common Pitfalls and How to Avoid Them
Quality Control and Review Processes
Q&A

Fill in the form and register for this exciting webinar. Learn practical approaches to developing compliant, reviewer-friendly eCTD overviews and summaries that improve submission quality and support successful regulatory outcomes.