Masterstudiengang „Drug Regulatory Affairs"


Modul 06 (WS 2022 / SS 2023)

Informationsmanagement, e-CTD

Präsenzzeit Studienarbeiten Prüfungsform Leistungspunkte
ca. 20 Stunden ca. 20 Stunden praktische Übungen 3


  • Wolfgang Witzel


Information- and Data Exchange in Regulatory Affairs
  • History of Regulatory Submission
  • Emerging Trends
  • Dynamic Submission Management
  • Solutions and Characteristics
Regulated Information Systems - Agency Perspective
  • Value of Electronic Information Systems
  • IDMP and SPOR
  • Pharmacovigilance Systems
  • Clinical Trials
Information Systems of the BfArM
  • Information Systems and their legal basis
  • PharmNet.Bund Portal - Purpose and User Groups
  • PharmNet.Bund Portal Use Cases
Document-Management for Regulatory Affairs
  • Paper vs. Electronic Documentation
  • Use Cases in Regulatory Affairs
  • Implementation of a DMS System
  • Organization, Training, Standardization
  • Vendor solution examples
  • Selection criteria and purpose of use
Artificial Intelligence in Drug Regulatory Affairs
  • History and Status
  • Ein Use Cases in Regulatory Affairs
  • Different concepts and methods
  • AI and Big Data – Data Mining
  • Business Process Automation
  • Europa und AI-Projects, ChatGPT
Planning and Management of Projects in Regulatory Affairs
  • Project and Data Management
  • Managing Regulatory Information
  • DRA Lifecycle Management
  • Important projects and respective data in Regulatory Affairs
  • Analysis of Data and Reporting
  • Project Management
Management of Documentation
  • Documents and Documentation
  • Medical Writing
  • Standard Operating Procedures
  • Implementation of a Content Management-System
  • (Goals, Process, Teams, Schedules)
Electronic Submission at Agencies
  • Process of Electronic Submission at the BfArM
  • EU Electronic Application Forms
  • Common European Submission Platform (CESP)
  • Online Regulations and relevant Laws
  • National Procedures
Scientific Databases
  • Introduction in Search and Research of Literature
  • What are the basics of relevant Databases?
  • Process and use cases (e.g. PubMed)
  • Requirements in Regulatory Affairs
Process of eCTD Compilation and Publishing
  • Documents and preparation
  • eCTD Table of Content
  • Step by Step Process of building an Electronic Submission
  • Publishing to Global Agency Portals
  • Review Process at Agencies
Process of eCTD Intake and Review at an Agency
  • eCTD Processing for EU-Regulators (CESP)
  • eCTD for different use cases (Common Repository and PSUR)
  • Technical Validation
  • Process of Assessments
Management Data for Electronic Application - Industry Perspective
  • PharmacoVigilance Legislation
  • EudraVigilance Database Management
  • The xEVMPD/SPOR Mandate Art57 Database
  • CTIS Clinical Trial Database


Teil 1:

Freitag   24. Februar 2023 von 8.30 – 18.00 Uhr
Samstag   25. Februar 2023 von 8.30 – 18.00 Uhr
Ort:   Online-Kurs

Teil 2:

Freitag   03. März 2023 von 8.30 – 18.30 Uhr
Samstag   04. März 2023 von 8.30 – 14.00 Uhr
Ort:   Pharmazeutisches Institut, Bonn-Endenich

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