Masterstudiengang „Drug Regulatory Affairs"
Studienmodule
Modul 01 (WS 2022 / SS 2023)
Definition und Aufgabenbeschreibung von Drug Regulatory Affairs, Good Regulatory Practices
| Präsenzzeit |
Studienarbeiten |
Prüfungsform |
Leistungspunkte |
| ca. 30 Stunden |
ca. 30 Stunden |
Studienarbeit |
5 |
Modulleiter/in
Themen
| 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 |
Studienplan
Teil 1:
|
|
|
| Freitag |
|
02. September 2022 von 8.30 – 18.30 Uhr |
| Samstag |
|
03. September 2022 von 8.00 – 16.00 Uhr |
| Ort: |
|
Uniclub |
Teil 2:
|
|
|
| Freitag |
|
16. September 2022 von 8.30 – 18.30 Uhr |
| Samstag |
|
17. September 2022 von 8.00 – 16.30 Uhr |
| Ort: |
|
Uniclub |
| |
|
|
| |
|
Abgabe Studienarbeit: 17.10.2022 |
UnterlagenNur für Mitglieder
