541-0006-00L Module 6: Regulatory Affairs
| Semester | Spring Semester 2021 |
| Lecturers | R. Furegati Hafner, R. Schibli |
| Periodicity | two-yearly recurring course |
| Language of instruction | English |
| Comment | Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. |
Courses
| Number | Title | Hours | Lecturers | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 541-0006-00 G | Module 6: Regulatory Affairs Block course (5 days) | 40s hrs |
| R. Furegati Hafner, R. Schibli |
Catalogue data
| Abstract | Students learn about the regulatory aspects of drug development, about the Swiss, European and FDA regulations, regulatory information and strategies, personalizing healthcare and the role of companion diagnostics, about special regulations for biosimilars, medical devices, generics, orphan drugs, GMOs and advanced therapeutics incl. gene therapy and pharmacovigilance. |
| Learning objective | • European regulations for medicinal products • Clinical trial directives and application procedures • Marketing authorization procedures in the EU • FDA regulations • Swiss authorities and regulations • Helvetisation of regulatory documents • Variations and change control • Pharmacovigilance • Regulatory aspects of packaging • Electronic submissions • Health economics and outcomes research • Special regulations: Biologics, Orphan drugs, Biosimilars, Pediatrics, Generics • How to search the web for regulatory information |
Performance assessment
| Performance assessment information (valid until the course unit is held again) | |
Performance assessment as a semester course | |
| ECTS credits | 2.5 credits |
| Examiners | R. Furegati Hafner, R. Schibli |
| Type | ungraded semester performance |
| Language of examination | English |
| Repetition | Repetition possible without re-enrolling for the course unit. |
Learning materials
| No public learning materials available. | |
| Only public learning materials are listed. |
Groups
| No information on groups available. |
Restrictions
| There are no additional restrictions for the registration. |
Offered in
| Programme | Section | Type | |
|---|---|---|---|
| CAS in Pharmaceuticals - From Research to Market | Modules | W |  |