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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules 

MDRA-26 (academic year 2024/2025)

Module 7 Quality Management / Medical Devices

Good practice rules, international standards, quality assurance systems and control, medical device law

  • 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
Prof. Dr. Werner Knöss, Dr. Angela Graf

Module contents

Quality management / Quality assurance

  • Quality and its importance in the pharmaceutical industry
  • Quality management (QM), quality assurance (QA), quality control (QC): importance for the pharmaceutical industry
    - Overview of QM systems and models
    - Differentiation from QA, overview of QA in the pharmaceutical industry (the PQA)
  • GMP, GCP, GLP, GxP ...
    - Differences and similarities

European legal framework and national implementation for GMP and GDP

  • Overview of GMP regulations
    - GMP and GDP requirements in laws and guidelines in the EU and Germany
  • National implementation of EU directives and guidelines on GMP and GDP
    - Ordinance on the Manufacture of Active Pharmaceutical Ingredients (AMWHV)
    - Pharmaceutical Trade Regulation

The system approach to quality assurance/QA systems

  • Definition of the responsibilities of authorised representatives and qualified persons (QP)
  • Introduction to the most important Q systems such as change control, documentation/archiving
  • Validation, Qualification, Deviation Management, Quality Risk Management and others

International implementation of the guidelines for monitoring in the area of GMP and GDP

  • Structure of German monitoring
  • Implementation of the AMGVwV

Quality assurance in public authorities

  • Implementation of QA systems in administrative management
  • Example of the application of Quality Risk Management in a public authority
  • Development in the EU, tasks of the Quality Assurance Working Party of the Heads of Medicine Agency (HMA)

Organisation and structure of the EU GMP guidelines including the annexes

Drug monitoring in the USA

  • Code of Federal Regulations
  • Food and Drug Administration, division into CBER and CDER

International organisations

  • European Directorate for the Quality of Medicines & HealthCare (EDQM)
  • Position and tasks of the organisation
  • Significance for the production of medicinal products
  • The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
  • Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)
  • World Health Organisation (WHO)

Measures against counterfeit medicines

  • Counterfeit medicines in the legal and illegal distribution chain
  • Concepts to combat counterfeiting/ WHO and IM-PACT
  • Measures in the EU: Identification mark and tamper-proof closure
  • Control of the supply chain (incl. parallel trade and internet pharmacies)
  • ACurrent requirements of relevant export markets
  • Role of regulatory intelligence in the implementation of measures
  • Regulatory aspects of voluntary originality labelling

Quality assurance in development

  • GMP in sterile production - hygiene, especially for biological products
  • Example application of quality risk management in the pharmaceutical industry

Medical devices

  • What are medical devices, differentiation from other product groups
  • Systematics of medical device law (new concept)
  • Implementation status and implementation difficulties of Regulation (EU) 2017/745 (MDR)
  • Role of economic operators under the MDR
  • Requirements for placing on the market (essential requirements, classification, conformity assessment, technical documentation, CE marking)
  • Quality management system for medical devices (EN ISO 13485)
  • The role of notified bodies
  • Medical device/medicinal product combinations
  • Clinical testing / clinical evaluation
  • European and national medical device vigilance system
  • Regulatory surveillance
  • Overview of the legal situation under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVD)

Study plan

Part 1
Friday 28.03.2025 von 08:30 - 18:30 Uhr Online
Quality Management
Saturday 29.03.2025 von 08:00 - 16:00 Uhr Online
Medical Devices
Part 2
Friday 04.04.2025 von 08:30 - 18:30 Uhr Online
Medical Devices
Saturday 05.04.2025 von 08:00 - 16:00 Uhr Online
Quality Management
Submission of study paper Monday, 05.05.2025  

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