Regula Furegati Hafner: Catalogue data in Autumn Semester 2019 |
| Name | Ms Regula Furegati Hafner |
| Address | Inst. f. Pharmazeutische Wiss. ETH Zürich, HCI H 417 Vladimir-Prelog-Weg 1-5/10 8093 Zürich SWITZERLAND |
| Telephone | +41 44 633 74 05 |
| Fax | +41 44 633 13 65 |
| regula.furegati@pharma.ethz.ch | |
| URL | http://www.postgraduate.pharma.ethz.ch |
| Department | Chemistry and Applied Biosciences |
| Relationship | Lecturer |
| Number | Title | ECTS | Hours | Lecturers | |
|---|---|---|---|---|---|
| 541-0007-00L | Module 7: Clinical Development 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 | Module 7 gives an overview about the several steps that have to be followed during the process of clinical development. | ||||
| Learning objective | • Preclinical bridge to clinical development • Strategy for clinical development • Regulatory aspects of clinical development • Good clinical practice (GCP) and quality assurance • First in human studies (Phase I), Proof of concept studies (Phase II), Registration studies (Phase III), Post-registration studies (Phase IV) • Monitoring • Organizational and financial aspects of clinical development • Portfolio and life cycle management • Data management and simulation of a clinical study • Personalized medicine | ||||
| 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. | ||||
| Literature | www.postgraduate.pharma.ethz.ch documents: essay | ||||
| 542-0001-00L | Module I: Pharmacy and Legislation Only for CAS in Radiopharmazeutischer Chemie, Radiopharmacy. The enrolment is done by the CAS study administration. | 4 credits | 6G | R. Schibli, R. Furegati Hafner | |
| Abstract | Module I: Knowledge of the fundamentals of development, preparation, testing and stability of sterile radiopharmaceutical preparations. Acquirement of basic information on European legislation in Radiopharmacy including GMP and Pharmacopoeia. Understanding basics of gene engineering and pharmacokinetics | ||||
| Learning objective | • Good manufacturing practice (GMP) of classical radiopharmaceuticals • GMP: industrial point of view • Molecular and cellular aspects of radiobiology • Pharmacopoeia • Pharmacopoeia – how to use it • Design of dosage forms for pharmaceuticals • Pharmaceutical packaging • Methods of preparation of sterile products • Aseptic preparation • The role of excipients in parenteral radiopharmaceutical preparations • Sterility testing and endotoxin determination • Particulate contamination • Principles of medicinal chemistry • An overview of modern pharmaceutical analysis • Genetic engineering • Stability and shelf-life of pharmaceuticals • (in)stability of radiopharmaceuticals • Legislation in radiopharmacy • European directives – GMP • Specific radiopharmaceutical legislation • Clinical trials directive and related documents • The small scale, non-commercial preparation of radiopharmaceuticals • GMP of PET radiopharmaceuticals • Quality assurance and preparation of SOP • Water for pharmaceutical use • Practicals: visit to hospital radiopharmacy • Basic concepts of pharmacokinetics • Drug regulatory affairs • Microbiology in Pharmacy • Visit to pharmaceutical company | ||||