| Detailed information |
| Original study plan |
Master's programme Medical Engineering 2022W |
| Objectives |
The participants should get an overview about historic development, the legal basis, the structure or composition and tasks of an ethics committee. The participants should also be trained on the essential key points regarding the submission of a clinical study to an EC.
|
| Subject |
- Historic developement
- Lega Basics
- Structure and composition of an EC
- Tasks of an EC
- Essential key points of the submission process
- Practical example
|
| Criteria for evaluation |
Compulsory participation in the first LVA or alternatively the submission of the written homework (practical example)
|
| Methods |
Lecture with practical example as homework
|
| Language |
German |
| Study material |
- Austrian Drug Law (AMG 2022)
- Medical Device Law (MPG 2021)
- Clinical Trial Regulation (EU-VO 536/2014)
- Medical Device Regulation (EU-VO 745/2017)
- Oö. Krankenanstaltengesetz (OöKAG)
- Declaration of Helsinki, 2013
- ICH-GCP E6 (R2)
- DIN EN ISO 14155
|
| Changing subject? |
No |
