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
| Teaching time | Study time | Type of examination | Credit points |
|---|---|---|---|
| ca. 30 hours | ca. 30 hours | Study paper | 5 |
Module leader
Dr. Jan Heun
Dr. Jan Heun
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
- 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
| 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 | |
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