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In your studies 'Drug Regulator Affairs'

©Frank Luerweg / Universität Bonn

Study modules

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

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

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

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

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

Quality assurance in development

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)

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