Masterstudiengang „Drug Regulatory Affairs"
Studienmodule
Modul 10 (WS 2024 / SS 2025)
Klinische Dokumentation
| Präsenzzeit |
Studienarbeiten |
Prüfungsform |
Leistungspunkte |
| ca. 30 Stunden |
ca. 30 Stunden |
Studienarbeit und Klausur |
6 |
Modulleiter/in
Themen
1 Basics of Clinical Trials
- Definition der Klinischen Prüfung
- Phasen der Arzneimittelprüfung
- Anwendungsbeobachtungen
|
2 Good Clinical Practice
- Terminology
- Essential documents
- Archiving
- Audit
|
3 GCP Inspections
|
4 Ethics in Clinical Research
- Declaration of Helsinki
- Ethics approval process
- Informed consent
|
5 Investigational Medicinal Products Documentation
|
6 Relevant Items in Clinical Trials
|
7 Clinical Pharmacology
- Phase I studies - background
- Pharmacokinetics, ADME
- Bioavailability
- Populationkinetics
- Pharmacogenetics
- Pharmacodynamics
- PK/PD-Correlation
|
8 Biometry in Clinical Research
- Statistische Auswertung
- Studiendesigns
- Multiples Testen
- Fallzahlbestimmung
- Datenmanagement
- Metaanalyse
- Subgruppenauswertung
- Interimsanalyse
- Epidemiologie
|
9 Clinical Trial Guidelines 1
- Women
- Elderly
- Children
- Vulnerable subjects
|
10 Regulatory Process in Clinical Development
- Paragraphen im AMG
- Vorlegung
- Überwachung, Audits, Inspektionen
- Europäische Besonderheiten
|
11 Clinical Trial Directive 2001/20/EC
- Chiral active substances
- Fixed combination medical products
|
12 Clinical Trials Guideline 2
- Vaccines
- Immunoglobulines
- Plasma-derived factors
- Recombinant factors
|
13 Clinical Development of Vaccines
- Background
- European public assessment reports
|
14 Clinical Development of Blood Products
- Background
- European public assessment reports
|
15 Clinical Trials Guidelines 3
- Drug Interactions
- QT-Interval prolongation
- Control group
- Modified release dosage forms
|
16 Safety in Clinical Trials
- Definitionen
- Causality assessment
- Anzeigepflicht, Meldungen
- Guidelines
- Stufenplan
|
17 Clinical Trial Guidelines 4
|
18 Clinical Section of Application Dossier
- Directive 75/318/EEC
- Notice to applicants
- Common technical document
|
| 19 Clinical Trial Performance
|
Studienplan
Teil 1:
|
|
|
| Freitag |
|
27. Juni 2025 von 8.30 – 18.30 Uhr |
| Samstag |
|
28. Juni 2025 von 8.00 – 16.00 Uhr |
| Ort: |
|
Online |
Teil 2:
|
|
|
| Freitag |
|
11. Juli 2025 von 8.30 – 18.30 Uhr |
| Samstag |
|
12. Juli 2025 von 8.00 – 16.00 Uhr |
| Ort: |
|
Uniclub |
| |
|
|
| |
|
Abgabe Studienarbeit: 11.08.2025 |
UnterlagenNur für Mitglieder
