Objective: The workshop aims to provide participants with a comprehensive understanding of the Electronic Common Technical Document (eCTD) format and its role in regulatory submissions for pharmaceutical products.
Agenda:
- Introduction to eCTD
- Overview of the eCTD format and its benefits
- Importance of eCTD in regulatory submissions
- Key Components of eCTD
- Structure of the eCTD dossier: Modules and sections
- Common technical documents included in the eCTD
- Requirements for electronic submission publishing
- Regulatory Requirements
- Regulatory authorities accepting eCTD submissions (e.g., FDA, EMA)
- Guidance documents and technical specifications for eCTD submissions
- GxP compliance considerations for eCTD preparation
- Creating and Compiling eCTD Submissions
- Software tools for eCTD compilation and validation
- Best practices for document formatting and naming conventions
- Strategies for efficient eCTD dossier assembly
- Submission Lifecycle Management
- eCTD lifecycle stages: Creation, submission, review, and archiving
- Managing changes and updates to eCTD submissions
- Regulatory agency interactions and communication during the submission process
- Hands-On Training
- Practical exercises demonstrating eCTD submission preparation
- Interactive sessions using eCTD publishing software
- Tips and tricks for troubleshooting common eCTD submission issues
- Case Studies and Examples
- Real-world examples of successful eCTD submissions
- Challenges encountered and lessons learned
- Case studies illustrating the benefits of eCTD in regulatory approval processes
- Future Trends and Considerations
- Emerging technologies and trends in eCTD submission
- Impact of global harmonization efforts on eCTD adoption
- Anticipated changes and updates to eCTD standards and regulations
- Q&A and Discussion
