Regulated Science Institute

Syllabus

Regulatory Operations and eCTD Submissions Certificate Program

37 lessons, about 12 hours. Online and self-paced, with a certificate when you finish.

Regulatory Operations Foundations

Establish the responsibilities, regulatory requirements, application categories, and authoritative technical standards governing entry-level pharmaceutical submission operations.

  1. 1Regulatory Operations Workflows and Accountability
  2. 2FDA Application Types and eCTD Coverage
  3. 3Submission Authority and Supported Standards
  4. 4Health Authority and Regional Checklists

CTD Document Classification

Develop accurate placement skills across all five CTD modules through document-purpose analysis, regulatory references, and controlled classification exercises.

  1. 5FDA Module 1 Document Placement
  2. 6Module 2 Regulatory Summaries
  3. 7Module 3 Quality Documentation
  4. 8Nonclinical and Clinical Study Reports
  5. 9CTD Placement Decision Framework
  6. 10Application Content Readiness Crosswalk
  7. 11CTD Document Inventory Practice

Submission Document Preparation

Teach controlled source-document handoffs, FDA-aligned PDF preparation, technical file conformity, and independent release verification.

  1. 12Source Document Control and Handoffs
  2. 13FDA PDF Preparation and Inspection
  3. 14File Formats and Metadata Quality
  4. 15Submission Inventory and Release Reconciliation

eCTD v3.2.2 Lifecycle

Develop operational competency in legacy eCTD package architecture, sequence metadata, document lifecycle operations, and subsequent submission planning.

  1. 16eCTD v3.2.2 Dossier Architecture
  2. 17Sequence Numbering and Metadata Reconciliation
  3. 18Document Lifecycle Operations and Current View
  4. 19Amendment Supplement and Reporting Schedules

eCTD v4.0 Transition

Teach modern eCTD message architecture, context-based lifecycle management, FDA forward compatibility, and region-specific implementation decisions.

  1. 20eCTD v4.0 Message Architecture
  2. 21Context Lifecycle and Document Reuse
  3. 22FDA v4.0 Acceptance and Standards
  4. 23Forward Compatibility Conversion Exercise
  5. 24Global eCTD Version Selection

Validation and FDA Dispatch

Build technical rejection-prevention skills through FDA validation criteria, defect correction, ESG NextGen transmission, and submission outcome reconciliation.

  1. 25FDA Validation Criteria and Severity
  2. 26Technical Rejection Troubleshooting Practice
  3. 27ESG NextGen Transmission and Acknowledgments
  4. 28January 2027 Validation Enforcement
  5. 29Submission Failure Investigation and Reconciliation

RIM and Records Governance

Apply vendor-neutral regulatory information management, submission planning, electronic record controls, archival reconciliation, and operational performance monitoring.

  1. 30Regulatory Information Management Data Models
  2. 31RIM Submission Planning Exercise
  3. 32Part 11 Electronic Records Controls
  4. 33Submission Archives and Operational Metrics

Practical Capstone and Career

Integrate CTD placement, multi-sequence lifecycle planning, technical rejection prevention, submission tracking, and RIM records into an interview-ready work sample and completion assessment.

  1. 34CTD Document Placement Capstone
  2. 35Multi Sequence Lifecycle Capstone
  3. 36Validation and RIM Reconciliation Capstone
  4. 37Career Portfolio and Final Assessment
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Regulatory Affairs 5
Clinical Operations 4
Quality & Compliance 5
Drug Safety & Pharmacovigilance 2
Market Access & HEOR 2
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