Roger Schibli: Katalogdaten im Frühjahrssemester 2023 |
| Name | Herr Prof. Dr. Roger Schibli |
| Lehrgebiet | Radiopharmazie |
| Sprechstunde | Nach Vereinbarung |
| Adresse | Inst. f. Pharmazeutische Wiss. ETH Zürich, HCI H 431 Vladimir-Prelog-Weg 1-5/10 8093 Zürich SWITZERLAND |
| Telefon | +41 44 633 74 64 |
| roger.schibli@pharma.ethz.ch | |
| Departement | Chemie und Angewandte Biowissenschaften |
| Beziehung | Ordentlicher Professor |
| Nummer | Titel | ECTS | Umfang | Dozierende | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 227-0383-00L | Medizinische Bildgebung I  | 3 KP | 3G | S. Kozerke, R. Schibli, M. P. Wolf | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kurzbeschreibung | Der Kurs führt in die Grundlagen der nichtinvasiven Bildgebung ein, einschliesslich Röntgenbildgebung, Computertomographie, Magnetresonanztomographie, Einzelphotonen- und Positronenemissionstomographie, Ultraschall und optische Bildgebung. Neben der physikalischen und technischen Methodik wird auch die Bewertung der Bildgebungsleistung behandelt, um relative Vorteile und Grenzen zu erkennen. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lernziel | Der Kurs befähigt die Studierenden: * die physikalischen und technischen Grundlagen der medizinischen Bildgebung zu erklären * die Leistung der Bildgebung zu charakterisieren * Bildinhalte zu interpretieren und zu analysieren * eine fundierte Auswahl von Modalitäten für klinische Fragestellungen zu treffen | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 535-0900-00L | Seminars on Drug Discovery and Development | 1 KP | 1K | R. Schibli, C. Halin Winter, J. Hall, J.‑C. Leroux, U. Quitterer, G. Schneider, H. U. Zeilhofer | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kurzbeschreibung | Vermittlung neuer Erkenntnisse im Bereich Arzneimittelfindung und -entwicklung anhand von Expertenvorträgen aus dem Hochschul- und Industriebereich. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lernziel | Einblick in aktuelle Forschungsgebiete im Gesamtbereich der Pharmazie. Vermittlung neuer Erkenntnisse im Bereich Arzneimittelfindung und -entwicklung. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Inhalt | Seminarreihe des Instituts für Pharmazeutische Wissenschaften. Expertinnen und Experten aus Akademia und Industrie berichten über neue Erkenntnisse. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 541-0001-00L | Module 1: Health System, Pharmabusiness and Marketing Findet dieses Semester nicht statt. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 KP | 3G | R. Schibli | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kurzbeschreibung | Students learn about the different health systems, primarily about the European and the Swiss specialities, then also in comparison with the US system. A short introduction is made about Marketing with focus on Pharma, the legislation and patents/licencing are discussed and pharmacooeconomic aspects and business development are explained and intensified through workshops. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lernziel | Pharmabusiness and Corporate Governance; Pharmamarketing with workshop; Healthcare systems in Switzerland and in the EU; Pharmacoeconomics with workshop; Data integrity for supply chain powered by blockchain; Opinion Leader Management, Workshop; Legislation; Patents and licences; Building Pharma 4.0 – Future Directions; Market Access, Pricing and Reimbursement; Business Development: Connected Health; | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Skript | Course documents in print and a link to the electronic version are distributed during the module. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Kompetenzen |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 541-0003-00L | Module 3: Quality and GxP Findet dieses Semester nicht statt. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 KP | 3G | R. Schibli | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kurzbeschreibung | Students learn about pharmaceutical regulations in Switzerland, EU and US, various quality systems and CAPA, quality risk management, life cycle management, quality assurance of biotechnological processis, process validation, quality by design, statistical tools in QA, computerized systems validation, quality aspects of packaging and the role of the qualified person. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lernziel | • Quality Risk Management • Quality Systems and CAPA • Pharmaceutical Regulations, Swissmedic and ICH Basics • GMP and its Legal Basis • US Regulations and Enforcement Systems • GxP Requirements with Focus on Distribution • Change Mangement, Life Cycle Mangement • Case Studies for Analytics and Production • QA of Biotechnological Processes • Quality Aspects of Therapeutic Antibodies • Workshop: How to write an effective SOP • Process Validation with Examples • Quality by Design • Statistical Tools in QA • Challenges and Trends in QA • Computerized Systems Validation • Quality Aspects of Packaging • The Role of the Qualified Person | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kompetenzen |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kompetenzen |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kompetenzen |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kompetenzen |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 542-0002-00L | Module II: Radiopharmaceutical Chemistry Findet dieses Semester nicht statt. Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy. The enrolment is done by the CAS study administration. | 4 KP | 6G | R. Schibli | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kurzbeschreibung | Knowledge about the fundamentals of radionuclide production and generator systems, design and in vitro-& in vivo-characterization of radiolabelled peptides and antibodies., chemistry of Tc, Re and other radiometals, including the usage of kits as well as of chemistry of 11C and 18F and of other radiohalogens. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Lernziel | • Introduction to radiopharmacy and physics • Radionuclide production • Generator systems • In vitro- and in vivo-characterization of radiolabelled peptides and antibodies • The chemistry of Tc and Re • Kits and pitfalls • Radiopharmaceutical chemistry with halogen isotopes • 18F- and 11C-radiolabelled pharmaceuticals • Chemistry of radiometals other than Tc and Re • Animal and in vitro models • Practical sessions: • Radiolabelling and quality control of antibodies • Mo/Tc-generator and use of kits including quality control and preclinical application • Ge/Ga-generator and 68Ga-radiolabelling of peptides including quality control/video cell labelling • Insight into the routine manufacturing of clinical PET radiopharmaceuticals • 11C- and 18F- radiolabelling for research • In vitro/preclinical characterization of PET radiopharmaceuticals | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Kompetenzen |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||