Regula Furegati Hafner: Katalogdaten im Frühjahrssemester 2021

NameFrau Regula Furegati Hafner
Inst. f. Pharmazeutische Wiss.
ETH Zürich, HCI H 417
Vladimir-Prelog-Weg 1-5/10
8093 Zürich
Telefon+41 44 633 74 05
Fax+41 44 633 13 65
DepartementChemie und Angewandte Biowissenschaften

541-0005-00LModule 5: Pharmaceutical Development and Production
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 KP3GR. Furegati Hafner, R. Schibli
KurzbeschreibungStudents 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
541-0006-00LModule 6: Regulatory Affairs
Only for CAS in Pharmaceuticals.

The enrolment is done by the CAS in Pharmaceuticals study administration.
2.5 KP3GR. Furegati Hafner, R. Schibli
KurzbeschreibungStudents 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
Nur für CAS in Pharmaceuticals.

Einschreibung nur über das Sekretariat des CAS in Pharmaceuticals.
1 KP2DR. Furegati Hafner, R. Schibli
KurzbeschreibungThe essay is an essential part of the CAS program „Pharmaceuticals – From Research to Market“ (CAS Pharm) and serves as final performance assessment.
LernzielThe essay documents the student’s competence development during the program as well as the transfer of acquired knowledge to professional practice/activities.
542-0003-00LModule III: Radiopharmacology and Clinical Radiopharmacy
Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy.

The enrolment is done by the CAS study administration.
4 KP6GR. Schibli, R. Furegati Hafner
KurzbeschreibungParticipants will understand concepts of Pharmacology, Toxicology and Fundamentals of Nuclear Medicine
Lernziel• Pharmakokinetics and kinetic-modelling
• Statistics and practical session
• Radiotracers in biochemistry and molecular pharmacology
• Selective modification of peptides and proteins to target GPCRs
• Demonstration of experimental set up: Peptide and protein modification, radioactive assays in biochemistry
• Visit ABX Radeberg
• Nuclear medicine: basics and therapy
• Immunology
• Drug interventions/interactions/adverse reactions
• Pharmacology basics, special aspects, clinical studies
• Toxicology
• Testsystems in toxicology and targeted therapeutics and cucleic acids
• Nuclear medicine: clinical diagnostic applications in neurology
• Nuclear medicine: visit to SPECT facility and radiopharmaceutical GMP lag (Tc, Ga, therapy)
• Radiological imaging modalities- technology and applications
• Nuclear medicine: clinical diagnostic applications in oncology
• Radiopharmaceutical monographs in the European pharmacopoeia
• Practical session, visit: cyclotron, GMP PET production and quality control, PET and PET/CT, therapy unit
• Radioligand-binding-assays/autoradiography
• In house tours in groups: radioligand-binding-assays, autoradiography, metabolite analytics with LC-MS, cyclotron and radiochemistry, highlights in Leipzig
• Biological effects of radiation
• Radiotracer transport and blood brain barrier
• Radiotracers for neuroimaging
Voraussetzungen / BesonderesTakes place from 15.03.2021 to 26.03.2021.