Advanced Electronic Submission Management (eCTD) Training Course

Advanced Electronic Submission Management (eCTD) Training Course

Introduction

The pharmaceutical and life sciences industries are undergoing a digital transformation in their regulatory affairs processes. The Electronic Common Technical Document (eCTD) has become the global standard for submitting applications to health authorities like the FDA and EMA. Advanced Electronic Submission Management (eCTD) Training Course is designed to equip professionals with the essential skills and practical knowledge to navigate the complexities of eCTD submissions. We'll delve into the core principles of eCTD publishing, lifecycle management, and global regulatory compliance. This course will empower you to streamline your submission workflows, reduce errors, and accelerate the drug approval process.

This program goes beyond theory, focusing on hands-on application and real-world case studies. Participants will learn to create, validate, and manage eCTD dossiers efficiently using industry-standard software. Our expert-led curriculum is updated to reflect the latest eCTD 4.0 standards and regional specificities, ensuring you stay at the forefront of regulatory operations. By mastering advanced electronic submission management, you will enhance your career prospects and drive significant organizational benefits, including faster time-to-market and improved compliance.

Course Duration

10 days

Course Objectives

1. Master eCTD publishing and dossier management for global regulatory submissions.
2. Navigate the eCTD lifecycle management from initial submission to post-approval changes.
3. Implement ICH eCTD guidelines and regional requirements for the US, EU, and Canada.
4. Conduct technical validation and quality control checks to ensure submission integrity.
5. Understand the core concepts of structured data and eCTD 4.0 transition.
6. Utilize regulatory information management (RIM) systems for seamless integration.
7. Optimize submission processes for accelerated approvals and faster time-to-market.
8. Resolve common eCTD errors and troubleshoot technical issues in real-time.
9. Apply best practices for document authoring and PDF publishing to meet eCTD standards.
10. Explore regulatory intelligence and global submission strategies.
11. Manage the complexities of variations, renewals, and amendments in eCTD format.
12. Ensure data integrity and audit trail compliance throughout the submission lifecycle.
13. Leverage automation and AI in regulatory affairs to enhance efficiency.

Organizational Benefits

• By mastering eCTD best practices, organizations can submit high-quality, technically valid dossiers, leading to fewer rejections and faster regulatory review times.
• Electronic submissions eliminate the need for paper-based processes, reducing printing, shipping, and manual labor costs.
• A well-structured eCTD process ensures all documents are compliant with global standards, reducing the risk of regulatory penalties. The system provides a robust audit trail, enhancing transparency and traceability.
• Automated tools and standardized workflows allow regulatory teams to manage submissions more efficiently, freeing up time to focus on strategic initiatives.
• Training on regional differences and global strategies enables companies to prepare a single core dossier for multiple markets, streamlining international expansion efforts.

Target Audience

1. Regulatory Affairs Professionals.
2. Regulatory Operations Specialists.
3. Dossier Publishers and Document Managers.
4. Pharmacovigilance and Clinical Trial Managers.
5. Quality Assurance (QA) and Quality Control (QC) Personnel.
6. IT and R&D Teams.
7. CRO (Contract Research Organization) Professionals
8. New Graduates and Career Changers.

Course Outline

Module 1: Introduction to eCTD and the Regulatory Landscape

• Understanding the eCTD Framework: This module defines the eCTD, its history, and its role as a global standard for regulatory submissions.
• ICH Guidelines: A deep dive into the International Council for Harmonisation (ICH) and its eCTD specifications.
• Regulatory Authorities: An overview of key health agencies (FDA, EMA, Health Canada, PMDA) and their eCTD requirements.
• The Paradigm Shift: Transitioning from paper-based submissions to a fully electronic, digital-first approach.
• Case Study: The First eCTD Submission A historical look at a company's transition from paper to eCTD, highlighting the initial challenges and long-term benefits.

Module 2: eCTD Structure and Module Organization

• The 5-Module Hierarchy: A detailed breakdown of the five modules of the eCTD
• Module 1 Regional Variations: A comparison of Module 1 requirements for the US (FDA), EU (EMA), and other key regions.
• Document Placement and Granularity: Best practices for organizing documents within the eCTD tree.
• XML Backbone and Technical Foundation: Understanding the technical infrastructure that supports the eCTD.
• Case Study: Building a New Drug Application (NDA) Dossier A step-by-step exercise in structuring a new drug submission, from Module 1 through 5.

Module 3: Lifecycle Management in eCTD

• Sequence Management: Understanding the concept of sequences and how they are used to manage updates and changes.
• Adding, Replacing, and Deleting Documents: Practical application of eCTD lifecycle operations.
• The Importance of the DTD (Document Type Definition): How the DTD governs document validation.
• Major vs. Minor Variations: Differentiating between types of post-approval changes and their eCTD implications.
• Case Study: Managing a Labeling Update A hands-on simulation of submitting a revised patient leaflet and a summary of product characteristics.

Module 4: Practical eCTD Publishing and Validation

• eCTD Publishing Software: An introduction to leading eCTD software tools and their functionalities.
• Technical Validation and QA Checks: Performing validation checks to ensure compliance with regulatory standards.
• Hyperlinking and Bookmarking: Creating internal and external links within the dossier for easy navigation.
• PDF Preparation for Submission: Best practices for optimizing PDF documents to be eCTD compliant.
• Case Study: Troubleshooting a Validation Failure A practical exercise in identifying and correcting common technical errors in a submission.

Module 5: Regional Specifics: FDA eCTD Submissions

• FDA eCTD Gateway: How to use the FDA's Electronic Submissions Gateway
• FDA Module 1 Requirements: A detailed look at the administrative and application forms required by the FDA.
• eCTD for INDs, NDAs, ANDAs, and BLAs: Specific requirements for different types of submissions.
• FDA Technical Conformance Guide: Navigating and applying the official FDA guidance.
• Case Study: An Abbreviated New Drug Application (ANDA) Submission A walkthrough of preparing and submitting an ANDA dossier to the FDA, focusing on bioequivalence data.

Module 6: Regional Specifics: EMA eCTD Submissions

• EMA eCTD Submission Portal: Understanding the EU's portal and submission process.
• EMA Module 1 Requirements: Key differences in the EU's administrative section.
• Centralized, Decentralized, and Mutual Recognition Procedures: Applying eCTD to different European regulatory pathways.
• Product Lifecycle Management (PLM): Specifics of managing variations and renewals in the EU.
• Case Study: A Marketing Authorization Application (MAA) A comprehensive example of preparing an MAA for submission via the centralized procedure.

Module 7: Introduction to eCTD 4.0

• The Future of Submissions: An overview of the eCTD 4.0 standard and its key enhancements.
• Structured Data and Information Models: The shift from a document-centric to a data-driven submission.
• Bi-directional Communication: The concept of two-way communication between sponsors and health authorities.
• Planning the Transition: Strategies for migrating from eCTD 3.2.2 to eCTD 4.0.
• Case Study: A Mock eCTD 4.0 Submission A look at a prototype submission using the new 4.0 standard to highlight key changes.

Module 8: Advanced Document Authoring for eCTD

• Source Document Requirements: Ensuring all source documents are submission-ready.
• PDF Optimization: Techniques for creating clean, searchable, and compliant PDF files.
• Hyperlink and Bookmark Best Practices: Advanced strategies for creating effective navigation within large dossiers.
• File Naming Conventions: The importance of consistent file naming and its impact on validation.
• Case Study: Preparing a Clinical Study Report (CSR) A hands-on session on formatting a complex CSR for eCTD compliance.

Module 9: Regulatory Information Management (RIM) Systems

• RIM System Overview: Understanding what RIM systems are and their role in modern regulatory operations.
• Integration with eCTD: How RIM systems automate and streamline the eCTD publishing process.
• Data Management and Tracking: Using RIM for real-time tracking of submissions and approvals.
• Vendor and Software Selection: Criteria for choosing the right RIM and eCTD tools.
• Case Study: Implementing a RIM System A project-based example of a company integrating a new RIM system to manage its global submissions.

Module 10: Submission Strategy and Planning

• Global Submission Strategy: Developing a cohesive plan for submitting to multiple regions simultaneously.
• Gantt Charts and Timelines: Project management tools for eCTD submissions.
• Team Roles and Responsibilities: Defining roles for regulatory, publishing, QA, and IT teams.
• Risk Mitigation: Identifying and addressing potential issues and delays in the submission process.
• Case Study: A Global Phase 3 Submission A simulated project plan for a large-scale, multi-region clinical trial dossier submission.

Module 11: Special Submission Types

• Investigational New Drug (IND) Applications: The specific eCTD requirements for INDs.
• Orphan Drug Submissions: Unique considerations for rare disease products.
• Drug-Device Combination Products: How to handle the eCTD for these complex products.
• Clinical Trial Submissions: The role of eCTD in submitting clinical trial applications and updates.
• Case Study: Submitting a Breakthrough Therapy Designation A detailed analysis of a submission for a new drug with an expedited review pathway.

Module 12: Compliance and Quality Control

• Regulatory Inspections: What to expect during a health authority inspection of your electronic submissions.
• Audit Trails and eCTD: Ensuring a complete and accurate history of all submission activities.
• Internal QA/QC Processes: Establishing robust internal procedures for reviewing and validating dossiers.
• Best Practices for Regulatory Archives: Long-term storage and management of eCTD submissions.
• Case Study: Responding to a Regulatory Query A hands-on exercise in preparing a response to a formal query from a health authority.

Module 13: Advanced Tools and Automation

• AI and Machine Learning: Exploring the use of AI for automating document classification and quality control.
• XML Authoring: Creating and managing the core XML backbone of the eCTD.
• Robotic Process Automation (RPA): How RPA can be used to streamline repetitive eCTD tasks.
• Data-Driven Submissions: A forward-looking module on the use of structured data in submissions.
• Case Study: Automating a Deficiency Letter Response A simulated example of using automation to expedite a response to a regulatory deficiency.

Module 14: eCTD for Generics and Biosimilars

• ANDA (Abbreviated New Drug Application) eCTD: Specific requirements for generic drug submissions.
• Bioequivalence Studies: How to submit bioequivalence data in eCTD format.
• Biosimilar Submissions: The unique challenges of submitting biosimilar dossiers.
• Bridging Studies and Data: Managing the data and documentation from bridging studies.
• Case Study: An ANDA Submission with Bioequivalence Data A step-by-step walkthrough of compiling an ANDA dossier.

Module 15: Final Capstone Project and Certification

• Capstone Project: A comprehensive, real-world project to build a complete eCTD dossier from a set of provided documents.
• Peer Review: Collaborative review of capstone projects to provide constructive feedback.
• Final Exam and Certification: A final assessment to demonstrate mastery of all course concepts.
• Career Pathways: A discussion on career opportunities and certifications in the regulatory affairs and eCTD field.
• Case Study: Post-Market Surveillance and Submission A final case study on how eCTD is used for post-market safety updates and renewals.

Training Methodology

• Interactive Lectures.
• Hands-on Workshops.
• Real-World Case Studies.
• Group Discussions and Q&A.
• Simulated Submission Environment.
• Mentorship and Peer Review.

Register as a group from 3 participants for a Discount

Send us an email: [email protected] or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.