CTD/eCTD REGULATORY AFFAIRS

This course covers the fundamentals of Regulatory Affairs (RA), ICH guidelines, dossier compilation, eCTD structure, and electronic submission requirements for regulatory agencies such as USFDA, EMA, and other global authorities. Participants will gain expertise in organizing regulatory dossiers, structuring technical documents, and using eCTD submission tools to ensure compliance with evolving industry standards.

Key Learning Modules:

1. Introduction to Regulatory Affairs (RA) Profession

✔ Role and Importance of Regulatory Affairs – Understanding its impact on drug approval

✔ Overview of Worldwide Regulatory Agencies – USFDA, EMA, MHRA, TGA, PMDA, and others

✔ Pharmaceutical Industry Overview – Functions of R&D, Production, RA, QA, Project Management, and Supply Chain 2. ICH and Common Technical Document (CTD)

✔ Overview of ICH (International Council for Harmonisation) – Global regulatory alignment

✔ Introduction to CTD – Structure, purpose, and regulatory significance 3. Organization of CTD (Dossier Compilation & Structure)

✔ Module 1: Administrative & Prescribing Information (Region-specific)

✔ Module 2: Common Technical Document Summaries (Overall drug submission summary)

✔ Module 3: Quality (CMC Section) – Chemistry, Manufacturing & Controls

✔ Module 4: Nonclinical Study Reports – Preclinical data organization

✔ Module 5: Clinical Study Reports – Structuring clinical trial data 4. Introduction to eCTD (Electronic Common Technical Document)

✔ Need for Harmonization – Transition from paper-based submissions to eCTD

✔ Evolution of CTD & eCTD Modules – Understanding submission lifecycle

✔ Document Granularity & Structure – Organizing and managing submission documents

✔ Advantages of eCTD – Efficiency, consistency, and regulatory compliance 5. Technical Aspects of eCTD Submission

✔ Understanding eCTD Builder Software – Need and application in regulatory submissions

✔ DTD (Document Type Definition) & Index.xml File – Structuring eCTD submissions

✔ Regional xml Files & USFDA Submission Requirements – Regulatory expectations and best practices

✔ File Formats Supported in eCTD for USFDA – Compliance with regulatory specifications

✔ PDF Specifications for USFDA – Formatting rules for document submissions

✔ Folder Structure & Study Tagging File (STF) – Proper organization of study-related data

✔ RSN (Regulatory Submission Number) Concept – Numbering and tracking of submissions

✔ Final Submission Preparation & Best Practices – Ensuring a successful eCTD submission

✔ Key Considerations for eCTD Submission – Common challenges and solutions

Who Should Attend?

✅ Regulatory Affairs Professionals & Aspiring RA Specialists

✅ Pharmaceutical & Biotech Industry Professionals involved in dossier submissions

✅ Medical Writers & Quality Assurance Personnel working on compliance documentation

✅ Clinical Research Professionals & Project Managers handling submission-related

data

✅ Life Science Graduates & Professionals looking to build a career in Regulatory Affairs