Introduction
Features
Core Learning Areas
Related Courses
Who should attend
Royed Training delivers a 1 Week Competency Development Program in eCTD Submission Management, enabling participants to develop practical regulatory submission competencies with a strong focus on eCTD v4.0.
This intensive program provides practical and strategic understanding of electronic Common Technical Document (eCTD) lifecycle management, covering planning, publishing, validation, submission, lifecycle operations, and regulatory agency expectations. Participants will gain real-world exposure to eCTD v3.2.2 and transition readiness for eCTD v4.0, including structure changes, message-based submissions, controlled vocabularies, and future-ready regulatory compliance.
The program is designed using real-life job simulations, case studies, and hands-on exercises, enabling participants to understand how submission management teams actually work within regulatory affairs departments. By the end of the week, learners will be confident in managing global regulatory submissions in compliance with FDA, EMA, PMDA, Health Canada, and other major agencies, with a future-proof understanding of eCTD v4.0 implementation.
As a result, participants develop dual expertise:
- A strong foundation in global regulatory document publishing and eCTD submissions.
- The ability to understand AI tools used in eCTD publishing.
Course Snapshots:
- Course Code: RYD-142
- Title of the course: Competency Development Program in eCTD Submission Management
- Duration: 1 Week
- Nature of the course: Online learning course. So the course can be accessed online anywhere 24×7.
- Eligibility : Graduation in any discipline. Even final year graduation students can apply.
- Course Certificate: Certificate will be provided at the end of the successful completion of the course.
Features of the Course:
- 1-Week Intensive Competency Program – Fast-track skill development
- Major Focus on eCTD v4.0 – Structure, concepts, and transition readiness
- Hands-on Submission Management Training
- Real-Life Regulatory Submission Simulations
- Lifecycle Management & Change Control Training
- eCTD Publishing & Validation Concepts (Tool-Agnostic)
- Global Regulatory Agency Expectations Covered
- Online / Live Instructor-Led / Blended Delivery Options
- Course Completion Certificate from Royed Training
Foundations of eCTD
- Regulatory submission landscape and evolution from paper → CTD → eCTD
- Overview of CTD modules (Module 1–5) and regional requirements
- Roles and responsibilities in submission management teams
eCTD Structure & Lifecycle Management
- eCTD backbone files, XML, leaf elements, metadata
- Lifecycle operations: new, replace, append, delete
- Submission sequencing and version control
- Regulatory query handling and response submissions
eCTD Publishing & Validation
- Submission readiness checks and technical quality review
- Validation criteria and common errors
- Agency-specific technical requirements (FDA, EMA, PMDA, HC)
- Best practices for submission quality and compliance
Major Focus: eCTD v4.0
- Why eCTD v4.0? Regulatory vision and global roadmap
- Key differences: eCTD v3.2.2 vs eCTD v4.0
- Message-based submission concept
- Controlled vocabularies and structured data elements
- Benefits of v4.0 for lifecycle management and review efficiency
- Transition strategy from v3.2.2 to v4.0
- Organizational and system readiness for eCTD v4.0
Global Submission Strategy
- US FDA, EMA, PMDA, Health Canada submission expectations
- Regional Module 1 considerations
- Submission planning and coordination across regions
Case Studies & Practical Simulation
- End-to-end mock eCTD submission workflow
- Lifecycle change scenario simulations
- Deficiency handling and regulatory communication scenarios
Some related courses
Regulatory Submission training content is also part of the International Drug Regulatory Affairs (EPGIDRA) and Drug Biologic Medical Device Regulatory Affairs (PGDBMRA) course. Therefore, a separate course is not required if you already taking EPGIDRA or PGDBMRA course.
- Regulatory Document Publishing Training
- CMC Writing one month certification Course
- Drugs, Biologics, Medical Devices Regulatory Affairs Course
- International Drug Regulatory Affairs
- Pharmaceutical International Business Management
- Drug Regulatory Affairs Course
- ANDA filing
- Stability Study
- Drug Dossier Preparation
This program is ideal for professionals who want to advance their careers in regulatory affairs and CMC documentation while mastering AI-powered tools:
- Regulatory Affairs Professionals – seeking to enhance their dossier preparation and submission skills.
- CMC Writers & Technical Authors – aiming to improve their expertise in Module 3 authoring and QOS preparation.
- Pharma & Biopharma R&D Professionals – who need to understand regulatory documentation requirements.
- Quality Assurance & Compliance Managers – focusing on data integrity, lifecycle management, and regulatory expectations.
- AI & Digital Transformation Enthusiasts – interested in applying AI/ML, NLP, and automation tools in regulatory processes.
- Graduates & Postgraduates in Life Sciences/Pharmacy – aspiring to build a career in global regulatory affairs.
Section 1Introduction to regulatory document publishing, NeSS and eCTD
Lecture 1Introduction to Regulatory Publishing | eCTD | NeSS | Regulatory Submission Workflow | Key Competencies Required for Regulatory Publishing Professionals
Lecture 2Overview of Global Regulatory Agencies and how their expectations impact regulatory publishing and submission workflows
Lecture 3Types of Regulatory Documents | Implications from regulatory publishing point of view
Lecture 4Regulatory vs Cross-Functional Documents | Document Ownership Mapping | Document Workflow: From Authoring to Submission
Lecture 5Core Characteristics of Regulatory Documents | Clarity and Readability | Formatting Compliance | Navigability (Bookmarks, Hyperlinks) | File-Naming Standards | Version Control & Document Finalization | Metadata | Lifecycle Operator | Granularity | OCR | Annotations, Comments & Markups
Lecture 6Characteristics of Module-Specific Documents | How Publishing Ensures Document Integrity | Common Document Errors & How Publishing Detects Them
Lecture 7Cross Functional Review Mechanism
Lecture 8Best Practices CFD Review
Lecture 9Regulatory Publishing Collaboration Workflow
Lecture 10Framework and ICH Guidelines | M4 | M8 | XML backbone structure | Metadata attributes | File placement rules | Life cycle operations (new, replace, delete) | Technical validation criteria | Granularity and Placement Principles
Section 2Compiling Dossier Preparation
Lecture 11Introduction to Common Technical Document (CTD)
Lecture 12CMC Dossier & Compliance Management
Lecture 13Key Consideration for Drug Master File Preparation and Submission
Lecture 14Practical Understanding on Drug Master File Preparation and Submission
Lecture 15Associated Learning: Site Master File - Detailed Understanding
Lecture 16Drug Master File - Global Perspective [Across Different Regions]
Lecture 17Electronic Common Technical Document (ECTD)
Lecture 18Regional Dossier Differences | US | EU | China | Japan | India | ASEAN | GCC / Middle East | LATAM | eCTD requirements
Lecture 19Regionwise dossier comparison charts | Module 1 | Submission Format - eCTD | XML Backbone | Metadata requirements | Granularity | Language requirements
Lecture 20Regulatory Publishing scenario-based assessment on CTA, IND, NDA, BLA, MAA, Annual Reports, and Variations
Section 3eCTD v4.0 and Publishing Advanced Training
Lecture 21eCTDV4.0 Fundamental Understanding | Structures | Key Features
Lecture 22eCTDV4.0 Structure | Lifecycle Management
Lecture 23eCTD Validation | Managing Validation | Tool Types | Types of Error | Validation Error Management
Lecture 24eCTD Validation Tools
Lecture 25eCTD Publishing Cycle
Lecture 26HL7 - Structure and Understanding in the context of eCTD V4.0
Lecture 27Tips and Submission Readiness Checklist
Lecture 28eCTD Submission Checklist Format
Lecture 29Regulatory Publishing Document Control Challenges
Lecture 30Document Control Checklist
Lecture 31Leaf Structure Analysis | Common Error in Leaf Structuring
Lecture 32Formatting Rules Templated and Agency Specification
Lecture 33Versioning for Regulatory Publishing
Lecture 34File Naming Standard
Lecture 35Text Recognition and Optical Character Recognition (OCR)
Lecture 36Versioning File Naming OCR - How they work together
Lecture 37Final Document Assembly
Lecture 38Visual Diagram : eCTD Structure and XML Hierarchy
Lecture 39TOC and CI Management
Lecture 40Initial Submission & Maintenance Submission
Lecture 41Managing Lifecycle Operators - NEW REPLACE DELETE APPEND
Lecture 42eCTD Dossier Lifecycle - Multi Sequence View
Lecture 4310 Year eCTD Lifecycle : Sequence Evolution Diagram - Sequence Management Simulation
Lecture 44Global Decision Tree - Classifying Post Approval Changes
Lecture 45eCTD Technical Validation | Typical issues | Resolutions
Lecture 46eCTD Validation Readiness Checklist
Lecture 47QC Checklist Design and Pre Submission Review
Lecture 48Submission Gateway | FDA ESG • EMA CESP • Health Canada Portal • PMDA Gateway
Lecture 49Regulatory Publishing Simulation
Lecture 50Pre-Gateway Submission Review Checklist | Post Submission Confirmation
Section 4CCDS - Labelling and Artwork Management
Lecture 51CCDS Management
Lecture 52CCDS Management Tools - Native, AI Plus | Key Functionalities
Lecture 53AI Augmented Labelling Compliance System
Lecture 54Label Drift in CCDS Management | Simulation Case Study | AI Based Workflow in Label Drift detection and management
Lecture 55AI Review of Labels, PI and SMPC with help of the Case Based Simulation | 4 Case Simulations
Lecture 56CCDS Management Case Study | Pregnancy Warning Upgrade Case Study
Lecture 57CCDS Management Case Study | Dosage Section Conflict | Case Based Analysis
Lecture 58Centralized Artwork Operation | Mechanism | Operation Step Planning
Lecture 59Case Study on Centralized Artwork Operation [Recall Management]
Lecture 60Artwork Management Terms | Key Understanding on Terminologies | Usage in Artwork Cases
Section 5Course Certification
