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541-0006-00L 2.5 Credits WBZ D-CHAB
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Module 6: Regulatory Affairs

Lecturers: Prof. Dr. Roger Schibli
Examiners: Prof. Dr. Roger Schibli, Regula Furegati Hafner
Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration.
VVZ CR n/a

Last Updated: 2026-02-05 16:37:50

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.

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

General Information

Language
English
Levels
WBZ
Frequency
Every two years

Examination

Type
ungraded semester performance

Course Components

Type Title Time & Place Hours
lecture with exercise Module 6: Regulatory Affairs
Does not take place this semester. Block course (5 days)
No time listed 40 h semesterly

Offered In