In your studies 'Drug Regulator Affairs'
©Frank Luerweg / Universität Bonn
Studienmodule
MDRA-25 (WS 2023/2024 und SS 2024)
Modul 1
| 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
* Unterrichtssprache Deutsch
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 | 08.09.2023 von 08:30 - 18:30 Uhr | Universitätsclub Bonn e.V. |
| Saturday | 09.09.2023 von 08:00 - 16:00 Uhr | Universitätsclub Bonn e.V. |
| Part 2 | ||
|---|---|---|
| Friday | 15.09.2023 von 08:30 - 18:30 Uhr | Universitätsclub Bonn e.V. |
| Saturday | 16.09.2023 von 08:00 - 16:30 Uhr | Universitätsclub Bonn e.V. |
| Submission of study paper | Sunday, 26.05.2024 | |
This information is only visible to members.
This information is only visible to members.