Map the five modules of the Common Technical Document to the data each regulatory function must supply.
Healthcare & Pharmaceutical Management
Regulatory Dossier Preparation Using the Common Technical Document Format
Build the skills to compile, structure and quality-check a full CTD regulatory dossier for submission to health authorities across major pharmaceutical markets.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
Every marketing authorisation application depends on a dossier that health authorities can navigate quickly and trust completely, yet many regulatory teams still struggle to assemble a Common Technical Document that is consistent across its five modules and ready for first-cycle approval. This course works through the CTD architecture module by module: the administrative and labelling content of Module 1, the summaries of Module 2, the chemistry, manufacturing and controls data of Module 3, the nonclinical study reports of Module 4 and the clinical study reports of Module 5. Participants compile a mock dossier section, draft a quality overall summary and a clinical overview, and check cross-referencing and consistency between modules using the checklists regulatory reviewers apply. The course also covers eCTD publishing conventions, lifecycle sequencing for variations and renewals, and how to structure responses to health authority questions. By the end, participants can plan, assemble and quality-review a submission-ready dossier for FDA, EMA or other ICH-aligned markets.
Expected Learning Outcomes
Compile a Module 3 quality summary that presents drug substance and drug product data consistently.
Draft a clinical overview and quality overall summary that meet ICH M4 expectations for clarity and completeness.
Apply eCTD publishing conventions to sequence submissions, amendments and lifecycle variations correctly.
Identify gaps between available study data and dossier requirements before a submission deadline is set.
Structure responses to health authority information requests within the existing dossier framework.
Coordinate contributions from quality, nonclinical, clinical and regulatory teams into one submission timeline.
Who Should Attend
Regulatory affairs officers preparing marketing authorisation submissions.
CMC and quality professionals contributing Module 3 documentation.
Clinical and medical writers drafting overviews and summaries for a dossier.
Regulatory operations staff responsible for eCTD publishing and submission tracking.
Project managers coordinating cross-functional dossier compilation timelines.
Pharmaceutical company staff moving into regulatory affairs from another function.
Course Modules
Select any module to see its sessions and points.
01CTD Structure and Regulatory Submission Fundamentals
2 sessions · 8 points
Session 1Mapping the Five-Module CTD Architecture
- Examine the purpose of each CTD module and the type of evidence it is designed to present to reviewers.
- Compare the regional Module 1 requirements set by the FDA, the EMA and other ICH-aligned authorities.
- Build a document tracking matrix that links each dossier section to its source data and owner.
- Assess a sample dossier against the ICH M4 organisation of the Common Technical Document.
Session 2Regional Requirements Across FDA, EMA and ICH Markets
- Distinguish the administrative, labelling and prescribing information each region requires in Module 1.
- Plan a submission calendar that accounts for differing regional review timelines and procedures.
- Identify where national language and formatting requirements affect an otherwise harmonised dossier.
- Draft a regional variation log that records where content departs from the core CTD dossier.
02CTD Quality Documentation and CMC Data Compilation
2 sessions · 8 points
Session 1Drug Substance and Drug Product Quality Data
- Compile drug substance data covering manufacture, characterisation and control of the active ingredient.
- Assemble drug product development data that justifies the chosen formulation and manufacturing process.
- Check specifications and analytical methods for consistency between drug substance and drug product sections.
- Cross-reference Module 3 content against the quality overall summary for factual consistency.
Session 2Stability, Specifications and Manufacturing Process Description
- Organise stability data into the format reviewers expect for shelf-life and storage-condition claims.
- Write a manufacturing process description that matches the validated process and batch records.
- Set specification acceptance criteria that align with pharmacopoeial and ICH quality guidelines.
- Prepare a Drug Master File cross-reference letter for an externally sourced active ingredient.
03Nonclinical and Clinical Summary Development
2 sessions · 8 points
Session 1Writing the Quality Overall Summary and Clinical Overview
- Draft a quality overall summary that synthesises Module 3 data into a concise regulatory narrative.
- Write a clinical overview that presents efficacy and safety findings in the sequence reviewers expect.
- Align overview conclusions with the underlying study reports to avoid inconsistencies reviewers flag.
- Practise editing an overview for a reviewer who has not seen the underlying study data before.
Session 2Structuring Nonclinical and Clinical Study Reports
- Organise nonclinical study reports into pharmacology, pharmacokinetics and toxicology summaries.
- Structure a clinical study report synopsis that highlights design, endpoints and key results clearly.
- Build a tabulated summary of clinical studies that supports the integrated summary of safety.
- Check that literature references cited in overviews are indexed correctly within the dossier.
04eCTD Publishing and Submission Lifecycle Management
2 sessions · 8 points
Session 1eCTD Publishing Tools and Submission Sequencing
- Apply eCTD granularity and file-naming conventions when assembling a publishing-ready submission.
- Sequence an initial submission, amendments and supplements within a single eCTD lifecycle.
- Run technical validation checks on an eCTD package before it is transmitted to a health authority.
- Build a submission content plan that flags which sections change across a product's lifecycle.
Session 2Responding to Queries, Variations and Renewals
- Draft a structured response to health authority questions that references the affected dossier sections.
- Plan a variation submission that updates manufacturing, labelling or quality information correctly.
- Prepare a renewal dossier that consolidates post-approval changes since the original authorisation.
- Track commitments made to health authorities through to closure across submission cycles.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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