Roger Schibli: Catalogue data in Spring Semester 2022 |
| Name | Prof. Dr. Roger Schibli |
| Field | Radiopharmacy |
| Consultation hours | By appointment |
| Address | Inst. f. Pharmazeutische Wiss. ETH Zürich, HCI H 431 Vladimir-Prelog-Weg 1-5/10 8093 Zürich SWITZERLAND |
| Telephone | +41 44 633 74 64 |
| roger.schibli@pharma.ethz.ch | |
| Department | Chemistry and Applied Biosciences |
| Relationship | Full Professor |
| Number | Title | ECTS | Hours | Lecturers | |
|---|---|---|---|---|---|
| 227-0383-00L | Medical Imaging I  Only for Human Medicine BSc | 3 credits | 3G | S. Kozerke, R. Schibli, M. P. Wolf | |
| Abstract | The course introduces the foundations of noninvasive imaging including X-ray imaging, Computed Tomography, Magnetic Resonance Imaging, Single Photon and Positron Emission Tomography, Ultrasound and Optical Imaging. Besides the physical and technical methodology, the assessment of imaging performance is covered to enable students to identify relative advantages and limitations. | ||||
| Learning objective | The course enables students to: * explain physical and technical foundations of medical imaging * characterise imaging performance * interpret and analyse image content * make an informed choice of modalities for clinical question | ||||
| Content | Introduction + example cases of: * X-ray and Computed Tomography * Magnetic Resonance Imaging * Nuclear Imaging * Ultrasound Imaging * Optical Imaging * Hybrid Imaging | ||||
| 535-0900-00L | Seminars on Drug Discovery and Development | 1 credit | 1K | R. Schibli, K.‑H. Altmann, C. Halin Winter, J. Hall, J.‑C. Leroux, U. Quitterer, G. Schneider, H. U. Zeilhofer | |
| Abstract | State-of-the-art information on drug discovery and development by experts from academia and industry. | ||||
| Learning objective | State-of-the-art information on drug discovery and development. | ||||
| Content | Seminar series of the Institute of Pharmaceutical Sciences. Experts from academia and industry report on relevant topics. | ||||
| 541-0001-00L | Module 1: Health System, Pharmabusiness and Marketing Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 credits | 3G | R. Furegati Hafner, R. Schibli | |
| Abstract | 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. | ||||
| Learning objective | 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; | ||||
| Lecture notes | Course documents in print and a link to the electronic version are distributed during the module. | ||||
| 541-0003-00L | Module 3: Quality and GMP Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 credits | 3G | R. Furegati Hafner, R. Schibli | |
| Abstract | 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. | ||||
| Learning objective | • 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 | ||||
| 541-0005-00L | Module 5: Pharmaceutical Development and Production Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 credits | 3G | R. Schibli | |
| Abstract | 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. | ||||
| Learning objective | • 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 Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 2.5 credits | 3G | R. Schibli | |
| 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 | ||||
| 541-1000-00L | Essay Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | 1 credit | 2D | R. Furegati Hafner, R. Schibli | |
| Abstract | The essay is an essential part of the CAS program „Pharmaceuticals – From Research to Market“ (CAS Pharm) and serves as final performance assessment. | ||||
| Learning objective | The essay documents the student’s competence development during the program as well as the transfer of acquired knowledge to professional practice/activities. | ||||
| 542-0002-00L | Module II: Radiopharmaceutical Chemistry Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy. The enrolment is done by the CAS study administration. | 4 credits | 6G | R. Furegati Hafner, R. Schibli | |
| Abstract | 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. | ||||
| Learning objective | • 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 | ||||