Global eCTD v3.2.2 and eCTD v4.0 Operations: Managing FDA and EU Submissions Complexity Across the Product Lifecycle

CDER and CBER have been accepting new regulatory applications in eCTD v4.0 format as of September 16, 2024.  The international ICH had previously developed a list of requirements for input into the Regulated Product Submissions (RPS) Project. ICH  assumed responsibility for the continued development of the  versions of the eCTD used globally for electronic regulatory submissions. CTD is an international term for Common Technical Documents, a standardized, organized  format by ICH for pharmaceutical submissions required in the US, EU, Japan and some other countries.  It's being replaced by its electronic equivalent - eCTD.  The CTD/eCTD consists of 5 modules,

1) Region-specific administrative and prescribing Information

2) an Executive Summary of the entire submission

3) Quality - Chemistry, manufacturing,  and controls for drug consistency and safety

4) Non-clinical animal and lab safety study reports

5) Human clinical trial study reports - drug safety and effectiveness.

This consistency in submission format streamlines the submission and review process, speeding up new product approvals. There have been several versions of eCTD released.

| AREAS COVERED

• ICH CTD Structure and 5-Module Organization
• FDA and EU Regional Submission considerations
• Versions of the eCTD - differences and similarities
• Global eCTD v3.2.2 and eCTD v4.0 Operations
• Version transition timeline for 4.0 change-over
• Lifecycle Management and submission updates

| WHO SHOULD ATTEND

• Quality Assurance Departments 
• Regulatory Affairs Departments 
• Research and Development Departments 
• Engineering Departments 
• Production Departments 
• Operations Departments 
• Marketing Departments

Course Director: John E. Lincoln

John E. Lincoln has over 40 years experience in U.S. FDA-regulated industries, 30 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan.  He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files.  He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).  In addition, John has prior experience in military, government, electronics, and aerospace.  He is a peer reviewed, author, teacher and speaker.   John is a graduate of UCLA.