Regula Furegati Hafner: Katalogdaten im Frühjahrssemester 2019 |
| Name | Frau Regula Furegati Hafner |
| Adresse | Inst. f. Pharmazeutische Wiss. ETH Zürich, HCI H 417 Vladimir-Prelog-Weg 1-5/10 8093 Zürich SWITZERLAND |
| Telefon | +41 44 633 74 05 |
| Fax | +41 44 633 13 65 |
| regula.furegati@pharma.ethz.ch | |
| URL | http://www.postgraduate.pharma.ethz.ch |
| Departement | Chemie und Angewandte Biowissenschaften |
| Beziehung | Dozentin |
| Nummer | Titel | ECTS | Umfang | Dozierende | |
|---|---|---|---|---|---|
| 541-0005-00L | Module 5: Pharmaceutical Development and Production Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 KP | 3G | R. Furegati Hafner, R. Schibli | |
| Kurzbeschreibung | Students learn about the pharmaceutical drug development process from the analytical characterisation of drug product both for small molecules and biotechnological drug substandes. The learnings include: formulation of clinical and market form, scale-up, 2D/3D printing technology for drugs, clinical trial supply, commercial packaging, supply chain management and continuous manufacturing. | ||||
| Lernziel | • Analytical characterization of the active pharmaceutical ingredient (API) • Drug formulation: clinical form and market form • Analytical characterization of formulations • Scale-up of manufacturing processes • Clinical trial supply • Commercial packaging • Technical project management • Supply chain management • Leading pharmaceutical operational excellence • Research trends in drug formulation and delivery Continuing Manufacturing | ||||
| 541-0006-00L | Module 6: Regulatory Affairs Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 KP | 3G | R. Furegati Hafner, R. Schibli | |
| Kurzbeschreibung | 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. | ||||
| Lernziel | • 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 | ||||
| 541-1000-00L | Essay Nur für CAS in Pharmaceuticals. Einschreibung nur über das Sekretariat des CAS in Pharmaceuticals. | 1 KP | 2D | R. Furegati Hafner, R. Schibli | |
| Kurzbeschreibung | The essay is an essential part of the CAS program „Pharmaceuticals – From Research to Market“ (CAS Pharm) and serves as final performance assessment. | ||||
| Lernziel | The essay documents the student’s competence development during the program as well as the transfer of acquired knowledge to professional practice/activities. | ||||