The Common Technical Document: CTD and eCTD (ICH M4 and M8)

A scientifically perfect dossier in the wrong format never reaches a reviewer. One broken hyperlink or one checksum mismatch stops it at the technical gate before the science is read. The Common Technical Document (CTD), agreed by ICH in 2000 and mandatory in its electronic eCTD form at the FDA and the EMA, organises every quality, safety and efficacy record into five modules shared by the United States, the EU and Japan. Fixing an error at your desk costs minutes. A rejected submission costs weeks. This two-hour online training makes your people confident dossier builders: structure, publish, validate.

Across ten lessons, this certified course covers all five CTD modules and the full eCTD lifecycle with real regulatory cases, from the ICH pyramid to eCTD v4.0 and IDMP. Its traceable certificate gives you audit-ready proof that you, or your team, are ready to apply the CTD and eCTD in regulated submissions.

Why teams choose this course

• Built with regulatory affairs and CMC experts, what reviewers look for in every lesson
• Real cases: thalidomide, the valsartan nitrosamine recall, TGN1412, Semler Research, the 2017 FDA eCTD mandate
• Covers the whole dossier life, not just the first filing: sequences, baselines, variations, gateways
• Module 1 for the US, the EU and Japan, so one core dossier serves three regions
• One-year access per learner and a CPD/CEU certificate your QA can verify online

What you’ll learn

• Place every quality, safety and efficacy document in the right module the first time
• Tailor Module 1 to the US, the EU and Japan without touching the shared core
• Write overviews that argue and summaries that inform, the way reviewers expect
• Navigate Module 3 CMC content, from drug substance to drug product and stability
• Build, sequence and update an eCTD with the XML backbone and four lifecycle operations
• Pass technical validation so your new drug application is never refused at the gate

Who should enroll

• Regulatory affairs associates, officers and submission publishing teams
• CMC, nonclinical and clinical specialists who feed the dossier
• Project managers and regulatory strategists planning a global filing
• Quality and compliance teams maintaining a dossier after approval. No prior experience needed.

Upon successful completion, each learner receives a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

Curriculum

Lesson: A Brief History of the CTD

Lesson 1: The CTD Framework, ICH and the Pyramid

Lesson 2: Module 1, Regional Administrative and Prescribing Information

Lesson 3: Module 2, Summaries and Overviews

Lesson 4: Module 3 Quality, Part 1, the Drug Substance

Lesson 5: Module 3 Quality, Part 2, Drug Product, Appendices and Regional

Lesson 6: Module 4, Nonclinical Study Reports

Lesson 7: Module 5, Clinical Study Reports

Lesson 8: From CTD to eCTD, the Electronic Format

Lesson 9: Lifecycle Management and Sequences

Lesson 10: Building, Validating and Submitting the Dossier

Conclusion

Glossary

Final Assessment