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. |
| 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 |