Advanced Regulatory Writing for CTD/eCTDC Training Course

Advanced Regulatory Writing for CTD/eCTDC Training Course

Introduction

Navigating the complex landscape of global regulatory affairs requires a specialized skill set. Advanced Regulatory Writing for CTD/eCTDC Training Course is meticulously designed to transform your understanding of regulatory writing and electronic submissions, focusing on the Common Technical Document (CTD) and its electronic counterpart, the eCTD. We'll delve into the strategic preparation, compilation, and lifecycle management of these critical dossiers, ensuring they meet the stringent requirements of major health authorities like the FDA, EMA, and others. Through a blend of theoretical knowledge and practical application, you will master the art of crafting precise, compliant, and submission-ready documents that accelerate drug and medical device approvals.

In an era of increasing digital transformation and global regulatory harmonization, mastering eCTD publishing and lifecycle management is more crucial than ever. This program moves beyond basic concepts to address advanced topics such as AI integration in regulatory writing, handling complex Module 3 (Quality) data, and navigating regional variations in Module 1 (Administrative Information). By the end of this training, you will be equipped to lead regulatory submissions with confidence, minimize technical validation errors, and ensure your organization's products reach the market efficiently and in full compliance.

Course Duration

10 days

Course Objectives

1. Master the ICH CTD/eCTD structure and its application for global regulatory submissions.
2. Develop advanced regulatory writing skills to create clear, compliant, and persuasive documents.
3. Learn to effectively compile and publish eCTD dossiers using modern software and tools.
4. Understand the nuances of eCTD lifecycle management for submissions, updates, and variations.
5. Interpret and apply specific regional requirements for Module 1 in major markets (US, EU, Canada).
6. Navigate the intricacies of Module 3 (Quality) documentation, including CMC data and stability studies.
7. Identify and avoid common eCTD technical validation errors that lead to rejections.
8. Explore the role of AI in regulatory writing and its future impact on the industry.
9. Apply best practices for regulatory intelligence to stay ahead of evolving guidelines.
10. Analyze and respond to regulatory deficiency letters and review comments.
11. Conduct a regulatory gap analysis of existing dossiers to ensure compliance.
12. Manage a regulatory project from initial planning to final submission.
13. Create a strategic regulatory submission plan for a new drug application (NDA) or marketing authorization application (MAA).

Organizational Benefits

• Expedite product approvals by reducing submission rejections and review cycles.
• Mitigate regulatory risk and avoid costly fines or delays due to non-compliant documentation.
• Streamline internal processes for document preparation, review, and electronic publishing.
• Prepare dossiers that are harmonized and adaptable for submission to multiple international health authorities.
• Elevate the expertise of regulatory and medical writing teams, creating an internal center of excellence.
• Reduce the need for external consultants and rework by improving the quality of in-house submissions.

Target Audience

1. Regulatory Affairs Professionals.
2. Medical Writers.
3. Quality Assurance (QA) Managers.
4. Clinical Development Professionals.
5. Project Managers.
6. Scientists & Researchers.
7. Pharmacovigilance Specialists
8. Recent Graduates.

Course Modules

Module 1: Foundations of Regulatory Writing & CTD

• Introduction to ICH, CTD, and eCTD frameworks.
• Key principles of clear, concise, and compliant writing.
• Regulatory document types and their purpose.
• Understanding the role of the regulatory writer in the drug development lifecycle.
• Case Study: Analyzing the structure of a successful NDA submission to the FDA.

Module 2: Mastering eCTD Module 1

• Overview of regional differences (US, EU, Canada, Japan).
• Preparing administrative information and prescribing information.
• Navigating different types of applications (NDA, MAA, BLA, ANDA).
• Best practices for creating a compliant Module 1.
• Case Study: A rejected EU MAA due to an incomplete Module 1, and how to fix it.

Module 3: Module 2 - CTD Summaries & Overviews

• Writing the Quality Overall Summary (QOS).
• Crafting the Nonclinical Overview and Summary.
• Preparing the Clinical Overview and Summary.
• Ensuring consistency and cross-referencing between modules.
• Case Study: A complex biological product submission where the Clinical Overview was flagged for inconsistencies, and the steps taken to resolve them.

Module 4: Module 3 - Quality (CMC) Documentation

• Structuring and writing the Chemistry, Manufacturing, and Controls (CMC) section.
• Managing stability data and analytical procedures.
• Documenting process validation and manufacturing details.
• Handling post-approval changes and variations.
• Case Study: A submission with a Module 3 deficiency letter from the FDA concerning impurity data.

Module 5: Module 4 - Nonclinical Documentation

• Compiling pharmacology, pharmacokinetics, and toxicology reports.
• Writing the Nonclinical Study Reports.
• Ensuring data integrity and compliance with Good Laboratory Practice (GLP).
• Strategic use of literature references.
• Case Study: A submission where nonclinical study reports lacked sufficient detail, leading to a request for further information from a health authority.

Module 6: Module 5 - Clinical Documentation

• Writing and formatting Clinical Study Reports (CSRs).
• Preparing clinical efficacy and safety summaries.
• Incorporating pharmacovigilance data and PSURs.
• Managing a clinical trial master file (TMF) for regulatory purposes.
• Case Study: A submission that received a serious adverse event (SAE) reporting query and the necessary documentation provided in response.

Module 7: Advanced Regulatory Writing Techniques

• Using AI-powered tools for drafting and data extraction.
• Strategies for writing a clear and persuasive regulatory strategy document.
• Editing and quality control of regulatory documents.
• Techniques for responding to health authority questions.
• Case Study: The use of an AI tool to rapidly summarize thousands of pages of clinical data for a Module 2 summary.

Module 8: eCTD Publishing & Technical Validation

• Introduction to eCTD publishing software and its functionality.
• Creating a validation checklist to prevent technical errors.
• Managing eCTD lifecycle operators (new, replace, append, delete).
• Submitting through regional portals (FDA ESG, EMA Gateway).
• Case Study: A rejected eCTD submission due to a corrupted XML backbone file.

Module 9: Regulatory Lifecycle Management

• Understanding the eCTD sequence and its importance.
• Submitting annual reports and routine updates.
• Managing post-approval changes and variations.
• Strategies for effective lifecycle management across multiple markets.
• Case Study: Maintaining a global dossier for a product with variations approved in the US and EU at different times.

Module 10: FDA Regulatory Submissions

• NDA, ANDA, BLA submission requirements.
• Navigating the FDA PDUFA process.
• Responding to Complete Response Letters (CRLs).
• Participating in pre-submission meetings.
• Case Study: A company receives a CRL and prepares a new submission addressing the deficiencies.

Module 11: EMA & EU Regulatory Submissions

• Centralized, Decentralized, and Mutual Recognition Procedures.
• Preparing for EMA scientific advice meetings.
• Understanding the role of the Rapporteur/Co-Rapporteur.
• Navigating the CTIS portal for clinical trials.
• Case Study: A successful centralized procedure MAA submission and the challenges overcome during the review.

Module 12: Advanced Global Dossier Strategy

• Harmonizing content for a global dossier.
• Managing country-specific variations in Module 1.
• ACTD (ASEAN CTD) vs. CTD format.
• Strategic planning for simultaneous global submissions.
• Case Study: A biotech company plans a multi-country submission strategy for a new oncology drug.

Module 13: Audits & Regulatory Inspections

• Preparing the regulatory dossier for an inspection.
• Roles and responsibilities during a regulatory audit.
• Responding to and remediating audit findings.
• Ensuring GxP compliance across all documentation.
• Case Study: An audit finding related to a submission's source documentation and the corrective actions taken.

Module 14: Medical Devices Regulatory Writing

• Medical Device regulatory frameworks (EU MDR/IVDR, FDA PMA/510(k)).
• Preparing Instructions for Use (IFU) and labeling.
• Writing a Clinical Evaluation Report (CER).
• Compliance with Unique Device Identification (UDI).
• Case Study: The submission of a new implantable medical device, detailing the CER and technical file compilation.

Module 15: The Future of Regulatory Writing

• Regulatory trends for 2025 and beyond.
• The impact of AI, blockchain, and automation.
• eCTD v4.0 and its new features.
• Skills for the next-generation regulatory professional.
• Case Study: A new startup utilizing AI-enhanced eCTD tools to automate dossier updates and streamline the submission process.

Training Methodology

Our training methodology combines a hybrid approach of theoretical instruction, hands-on workshops, and interactive case studies.

• Live Instructor-Led Sessions: Engaging lectures and Q&A with industry experts.
• Hands-On Workshops.
• Real-World Case Studies.
• Collaborative Group Projects: Working in teams to compile a mock CTD dossier.
• Personalized Feedback.

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.