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        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
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    • Downloads from A-Z
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    • DGRA
        Business Office Board of Directors Articles of Association
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        Walter Cyran Award DGRA Award DGRA Study Award DGRA Doctoral Scholarship
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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 1 Definition and Scope of Drug Regulatory Affairs and Good Regulatory Practice

  • Overview
  • 1
  • 2
  • 3
  • 4
  • 5
  • 6
  • 7
  • 8
  • 9
  • 10
  • 11
  • 12
Teaching time Study time Type of examination Credit points
ca. 30 hours ca. 30 hours Study paper 5
Module leader
Dr. Jan Heun

Module contents

Overview and statistics on marketing authorization procedures and drug regulations in the EU / US

Basic classification of medicines with definitions

Explanation of common regulatory terms

The registration dossier

  • Purpose
  • Structure
  • Preparation
  • Electronic submission
Product Variations in the EU / US

  • Statistics
  • Classification

The competent authorities in the EU and US

  • Organization
  • Responsibilities and duties
  • International cooperation between authorities

Meetings with authorities

  • Categories of meetings
  • Preparation of meetings
  • Scientific advice

Drug Regulatory Affairs in the pharmaceutical industry

  • Goals
  • Qualification and responsibilities of personel
  • Organizational aspects
  • Interactions with other departments within the company

Good Regulatory Practices

  • Definition
  • GRP at the authorities
  • GRP in the pharmaceutical industry
  • Best Practice Guides
  • Quality assurance in the pharmaceutical industry

Sources of regulatory information

Study plan

Part 1
Friday 13.09.2024 von 08:30 - 18:30 Uhr Universitätsclub Bonn e.V.
Saturday 14.09.2024 von 08:00 - 16:00 Uhr Universitätsclub Bonn e.V.
Part 2
Friday 27.09.2024 von 08:30 - 18:30 Uhr Universitätsclub Bonn e.V.
Saturday 28.09.2024 von 08:00 - 16:30 Uhr Universitätsclub Bonn e.V.
Submission of study paper Monday, 28.10.2024  

Lecturer

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Documents

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DGRA e.V.

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E-Mail: info@dgra.de

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