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The Common Technical Document Course & Certification
Intermediate
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The Common Technical Document
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About
The Common Technical Document (CTD) training provides comprehensive knowledge of preparing, organising and managing regulatory submissions using the ICH CTD framework. The course covers the five-module structure, regional requirements, Module 2 summaries and overviews, Quality, Nonclinical and Clinical documentation, document granularity, content placement, references, and submission consistency.
This Common Technical Document Training Course provides practical understanding of applying CTD principles across pharmaceutical and biotechnology regulatory submissions, including dossier planning, document organisation, lifecycle management, and interpretation of current regulatory requirements. The course supports professionals in preparing structured, consistent and submission-ready CTD dossiers.
Who Should Enrol?
- Regulatory Affairs Professionals
- Regulatory Operations and Publishing Teams
- Regulatory Intelligence Professionals
- Clinical and Nonclinical Professionals
- Quality Assurance and Quality Professionals
- Medical Writers and Technical Authors
- Anyone involved in preparing, reviewing or managing CTD regulatory submissions
What you will learn
Understand the fundamentals of the Common Technical Document (CTD), including its purpose, five-module structure, ICH framework, and role in regulatory submissions.
Learn how CTD requirements apply across Modules 1 to 5, including regional requirements, Module 2 summaries and overviews, and Quality, Nonclinical and Clinical documentation.
Gain practical knowledge of document organisation, content placement, document granularity, tabulated listings, expert declarations, references, and consistency across the dossier.
Understand how to plan, prepare, review and maintain CTD submissions, including regulatory updates, regional implementation differences, lifecycle considerations, and practical dossier management.
Course Syllabus
- An argument, not an archive
- Four guidelines, four dates, one of them moving
- The region, the portable asset, and the leak between them
- A document is a file, and you decide where it ends
- One document, or three: the asymmetry between the modules
- Content against format, and where this course stops
- Cross-referencing, reconciliation and the plan that records it
- What Module 2 is for, and who reads it
- An Overview argues. A Summary presents
- 2.3, the Quality Overall Summary
- The pairing the numbering hides
- The page expectations, and why none of them is a cap
- What the EMA keeps rejecting in 2.4 and 2.5
- The MHRA invites you to draft the assessor's factual sections
- Two quality guidelines, and only one of them is in force
- 3.2.S: the drug substance, taught as an argument
- 3.2.P: the drug product, and the block everyone under-writes
- 3.2.A and 3.3: the appendices and the literature
- The reconciliation: what has to agree with what
- 3.2.R: the regional seam inside the harmonised module
- The M4Q(R2) draft, in full - and it is still a draft
- What Module 4 is, and what M4S(R2) actually governs
- Thirteen safety guidelines, and not one mentions the CTD
- One study, three documents: 4.2, 2.6 and 2.4
- Written, then tabulated - and the study that fits no template
- GLP asserted three times, by three people, at three levels
- Placements that catch people out, and absences to explain
- NCS-2026-04, constructed: five corrections and the time for them
- The guideline, and what Module 5 is actually for
- 5.2: a listing of all studies, and a reconciliation
- Placing a study report at 5.3
- ICH E3 and the report Module 5 is built out of
- Literature: 5.4, 2.7.5, and the habit that files both in one place
- From the synopsis to the Summary: 2.7 and what feeds it
- 2.5.6: where the whole application lands
- Restated at the close: what this course argued
- The dated positions this course rests on
- A granularity choice that binds for as long as the product lives
- Overviews written as short summaries, and figures printed as caps
- Module 2.3 built to a draft that is not in force
- Tabulated summaries treated as an appendix, and two dropped
- Only the studies relied on, and 2.5.6 assembled last
- The decisions in order, before a word of Module 2 is written
- One set of Modules 2 to 5, filed to the MHRA and to the EMA
- What this course did not claim, and why it did not
- The six items most likely to have moved since verification
- Five Things to Take From This Course
- 📘 Bonus: The Common Technical Document eBook (Free with purchase)
Course Benefits
Free eBook
Get our exclusive eBook with every purchase - a complete companion guide to the course, yours to keep forever
CPD Points
Gain Continuing Professional Development (CPD) Points, accredited by The Faculty of Pharmaceutical Medicine of the Royal College of Physicians of the United Kingdom. These can be used to count towards the distance learning element of any scheme that comes under the umbrella of The Academy of Medical Royal Colleges or any other scheme for which there is mutual recognition.
Certification
Receive a personal certificate to show your subject knowledge on course completion.
Affordable
You get excellent value through our cost-effective prices. We can also offer you group discounts on larger purchases.
Flexibility
The course saves you time through the convenience of online availability. This lets you complete the interactive course at your own comfort.
Keep Up to Date
You will stay up to date with changes to ICH CTD guidelines, regional regulatory requirements and submission practices, as our training courses are constantly monitored, reviewed and updated.
Practical and Risk-Based
The course reflects current CTD regulatory practice, so learners can apply structured, practical approaches to preparing, reviewing and managing CTD-based regulatory submissions.
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