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  • Home
  • DGRA
    • Aktuelles
    • Vorstellung
    • Geschäftsstelle
    • Vorstand
    • Mitgliederentwicklung
    • Förderung
        Walter-Cyran-Medaille DGRA-Förderpreis DGRA-Studienpreis Promotionsstipendium
    • Informationsmaterial
    • Satzung
    • Historie
  • Mitgliedschaft
    • Antrag Mitgliedschaft Firmenmitglied
    • Antrag Mitgliedschaft Privatperson
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    • Jahreskongresse
    • Workshops
    • Lunch & Learn
    • Schools
    • AGB
  • Degree programme
    • News
    • Offered courses
        Master's degree programme Certificate course Single modules Application Student advisory service Examination board
    • In your studies
        Study plan (MDRA-26) Study modules (MDRA-26) Study modules (MDRA-25) Internship Master's thesis Lecturer Literature
    • Testimonials
    • Career perspectives
    • Press and media
    • FAQ
    • Downloads from A-Z
  • Karriere
    • Stellenangebote
    • Praktikumsangebote
  • Kontakt
  • English
    • DGRA
        Business Office Board of Directors Articles of Association
    • Awards and Scholarship
        Walter Cyran Award DGRA Award DGRA Study Award DGRA Doctoral Scholarship
    • Membership
        Application membership companies Application membership private individuals
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Studienmodule

MDRA-25 (WS 2023/2024 und SS 2024)

Modul 6 Informationsmanagement, e-CTD

Von der Literaturrecherche über die Verarbeitung von Dokumenten und Daten bis zur Informationsbewertung und elektron. Einreichung

  • Overview
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Teaching time Study time Type of examination Credit points
ca. 20 hours ca. 20 hours Project work 3
Module leader
Wolfgang Witzel

Module contents

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

  • xEVMPD/IDMP/SPOR
  • PharmacoVigilance Legislation
  • EudraVigilance Database Management
  • The xEVMPD/SPOR Mandate Art57 Database
  • CTIS Clinical Trial Database


Study plan

Part 1
Friday 23.02.2024 von 08:30 - 18:00 Uhr Online
Saturday 24.02.2024 von 08:30 - 18:00 Uhr Online
Part 2
Friday 01.03.2024 von 08:30 - 18:30 Uhr
Saturday 02.03.2024 von 08:30 - 14:00 Uhr
Submission of study paper Sunday, 26.05.2024  

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Documents

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