CLINI INDIA hosted a comprehensive workshop on the Electronic Common Technical Document (eCTD) to support professionals in mastering one of the most critical aspects of pharmaceutical regulatory submissions. This workshop designed to empower participants with essential knowledge and practical skills required for preparing, submitting, and managing eCTD applications.
Why is eCTD Important?
In today’s pharmaceutical landscape, managing regulatory submissions in a standardized and efficient manner is crucial. eCTD provides a harmonized method for submissions, reducing administrative burdens and ensuring faster communication between regulatory bodies and industry players. By adopting eCTD, organizations benefit from:
What is eCTD?
The eCTD is an advanced system for the electronic submission of information to regulatory agencies. It is the standard format for submitting applications, amendments, and reports for medicinal product registrations across regions like the U.S., Europe, Japan, and Canada. The system streamlines and simplifies the submission process, enabling pharmaceutical companies to meet global regulatory requirements efficiently.
Objectives of the Workshop
The eCTD workshop hosted by CLINI INDIA was designed to cover both fundamental and advanced aspects of eCTD preparation and submission. Key objectives include:
- Understanding the Structure of eCTD: A detailed look at how modules are organized, from administrative documents to clinical study reports.
- Regulatory Guidelines: Insights into region-specific requirements and global harmonization efforts.
- eCTD Lifecycle Management: Learning how to manage product updates, amendments, and submission tracking.
- Hands-On Training: Practical exercises in compiling eCTD submissions, navigating software platforms, and understanding the technical complexities of dossier preparation.
