Search result: Catalogue data in Autumn Semester 2021

Pharmaceutical Sciences Master Information
Core Courses I
NumberTitleTypeECTSHoursLecturers
535-0030-00LTherapeutic ProteinsO3 credits3GC. Halin Winter, D. Neri
AbstractIn this course, various topics related to the development, GMP production and application of therapeutic proteins will be discussed. Furthermore, students will expand their training in pharmaceutical immunology and will be introduced to the basic concepts of pharmaceutical product quality management.
Learning objectiveStudents know and understand:
- basic mechanisms and regulation of the immune response
- the pathogenic mechanisms of the most important immune-mediated disorders
- the most frequently used expression systems for the production of therapeutic proteins
- the use of protein engineering tools for modifying different features of therapeutic proteins
- the mechanism of action of selected therapeutic proteins and their application
- basic concepts in the GMP production of therapeutic proteins
ContentThe course consists of two parts:
In a first part, students will complete their training of pharmaceutical immunology (Chapter 13 - 16 Immunobiology VIII textbook). This part particularly focuses on the pathogenic mechanisms of immune-mediated diseases. Deepened knowledge of immunology will be relevant for understanding the mechanism of action of many therapeutic proteins, as well as for understanding one major concern related to the use of protein-based drugs, namely, immunogenicity.
The second part focuses on topics related to the development and application of therapeutic proteins, such as protein expression, protein engineering, reducing immunogenicity, and GMP production of therapeutic proteins. Furthermore, selected examples of approved therapeutic proteins will be discussed.
Lecture notesHandouts to the lectures will be available for downloading under http://www.pharma.ethz.ch/scripts/index
Literature- Janeway's ImmunoBiology, by Kenneth Murphy (9th Edition), Chapters 12-16
- Lecture Handouts
- Paper References provided in the Scripts
- EMEA Dossier for Humira
535-0041-00LPharmacology and Toxicology IIIO2 credits2GM. Detmar, U. Quitterer
AbstractThe course is divided into two parts. The first part provides a detailed understanding of drugs and pharmacotherapy of infectious diseases and cancer. The second part gives an overview of the field of pharmacogenomics with a special focus on the role of genetic polymorphisms in disease susceptibility, drug response and adverse effects.
Learning objectiveThe course advances basic knowledge in pharmacology and toxicology. Special emphasis is placed on the interrelationship between pharmacological, pathophysiological and clinical aspects of drug therapy in the fields of infectious diseases and cancer. The course also provides an overview of the field of pharmacogenomics, with a special focus on the role of genetic polymorphisms in disease susceptibility, drug response and adverse effects.
ContentTopics include the pharmacology and pharmacotherapy of infectious diseases and cancer. In the field of pharmacogenomics, the course is focused on genetics, genome-wide association studies, genetic disease predisposition, examples of genetic variability of drug metabolism and drug responses, identification of new drug targets, relevance of pharmacogenomics for clinical drug development, and toxicogenomics.
Lecture notesA script is provided for each lecture course. The scripts define important and exam-relevant contents of lectures. Scripts do not replace the lecture.
LiteratureRecommended reading:
The classic textbook in Pharmacology:
Goodman and Gliman`s The Pharmacological Basis of Therapeutics
Laurence Brunton, Bjorn Knollman, Randa Hilal-Dandan.
13th edition (2017)
ISBN-10: 1259584739
ISBN-13: 978-1259584732

or

Klaus Aktories, Ulrich Förstermann, Franz Hofmann, Klaus Starke.
Allgemeine und spezielle Pharmakologie und Toxikologie.
12th edition (2017)
Urban & Fischer (Elsevier, München)
ISBN-13: 978-3-437-42527-7
535-0050-00LPharmacoepidemiology and Drug Safety Information O3 credits2GA. Burden, S. Russmann
AbstractIntroduction to the principles, methods and applications of pharmacoepidemiology and drug safety. Drug safety in the pharmaceutical industry and regulatory authorities, but also for hospital and office pharmacists. Another focus is the evaluation and interpretation of pharmacoepidemiological drug safety studies in the medical literature and the evaluation of benefits vs. risks.
Learning objectiveObjectives:
- To familiarize participants with the principle methods and applications of pharmacoepidemiology and drug safety that is relevant for industry, regulatory affairs, but also for clinical pharmacists in hospitals and office pharmacies.
- Perform independently a causality assessment of suspected adverse drug reactions in patients
- Study designs and biostatistics used for the quantitative evaluation of drug safety
- Setup of programs that can effectively reduce medication errors and improve drug safety in clinical practice, particularly in hospitals
Content- Historical landmarks of drug safety
- Pharmacovigilance and causality assessment
- Drug safety in premarketing clinical trials
- Descriptive, cohort and case-control drug safety study designs; Data analysis and control of confounding
- Pharmacoepidemiology and regulatory decision making in drug safety; Risk management plans (RMPs)
- Medication errors, clinical pharmacology / clinical pharmacy
- Clinical Decision Support Systems, Interventional Pharmacoepidemiology
- Pharmacoepidemiological databases, 'Big Data'
- Interactive discussion of many real-life examples for each topic
Lecture notesThis course will be a combination of formal lectures, group discussions and self-directed studies. Course material will be taught through seminars, case studies in small groups.
Reading material and scripts will be provided for each week.
LiteratureRecommended literature
- Rothman: Introduction to Epidemiology
- Strom, Kimmel, Hennessy: Textbook of Pharmacoepidemiology
- Gigerenzer: Risk Savvy - How to Make Good Decisions
535-0546-00LPatentsO1 credit1VA. Koepf, P. Pliska
AbstractKnowledge in the field of intellectual property, especially of patents and trademarks, with particular emphasis on pharmaceutics.
Introduction into intellectual property; prosecution of patent applications; patent information; exploitation and enforcement of patents; peculiarities in pharmaceutics and medicine; social, political and ethical aspects; Trademarks.
Learning objectiveBasic knowledge in the field of industrial property, especially of patents and trademarks, with particular emphasis on the chemical, pharmaceutical and biotech field.
Content1. Introduction into industrial property (patents, trademarks, industrial designs);
2. Prosecution of patent applications (patentability);
3. Patent information (patent publications, databases, searches);
4. Exploitation and enforcement of patents (possibilities of exploitation, licenses, parallel imports, scope of protection, patent infringement);
5. Peculiarities in pharmaceutics and medicine (supplementary protection certificates, experimental use exemption, therapy and diagnosis, medical indication);
6. Social, political and ethical aspects (patents and prices for medicinal products, traditional knowledge and ethnomedicine, bioprospecting and biopiracy, human DNA inventions);
7. Trademarks, types of trademarks, grounds for refusal, peculiarities of pharma-trademarks.
Lecture notesA script is provided in electronic form during the lecture.
Literature- Swiss Patents Act: https://www.admin.ch/opc/en/classified-compilation/19540108/index.html
- Swiss Trademarks Act: https://www.admin.ch/opc/en/classified-compilation/19920213/index.html
- Swiss Industrial-Designs Act: https://www.admin.ch/opc/en/classified-compilation/20000457/index.html
- European Patent Convention: http://www.epo.org/law-practice/legal-texts/html/epc/2010/e/ma1.html
- Patent Cooperation Treaty: http://www.wipo.int/pct/en/texts/articles/atoc.htm
- Swiss Federal Institute of Intellectual Property: https://www.ige.ch/en.html
- European Patent Office: http://www.epo.org/index.html
- World Intellectual Property Organization: http://www.wipo.int/portal/index.html.en
Prerequisites / NoticeNone
CompetenciesCompetencies
Subject-specific CompetenciesConcepts and Theoriesassessed
Techniques and Technologiesassessed
Method-specific CompetenciesAnalytical Competenciesassessed
Decision-makingfostered
Media and Digital Technologiesfostered
Problem-solvingassessed
Project Managementfostered
Social CompetenciesCommunicationfostered
Cooperation and Teamworkfostered
Customer Orientationfostered
Leadership and Responsibilityfostered
Self-presentation and Social Influence fostered
Sensitivity to Diversityfostered
Negotiationfostered
Personal CompetenciesAdaptability and Flexibilityfostered
Creative Thinkingfostered
Critical Thinkingfostered
Integrity and Work Ethicsfostered
Self-awareness and Self-reflection fostered
Self-direction and Self-management fostered
511-0000-00LDrug Discovery and Development Restricted registration - show details
Only for MSc Pharmaceutical Sciences.
O2 credits1G + 1SJ. Hall, U. Thibaut, K.‑H. Altmann, M. Arand, J. Scheuermann, R. Schibli, H. U. Zeilhofer
AbstractThis course provides an overview over the concepts and processes employed in today's drug discovery and development. It has an introductory character but will also provide more detailed insights employing real life examples. The course combines lectures and interactive elements with active participation of the students.
Learning objectiveStudents
- Understand the drug discovery process and can explain major approaches and relevant technical terms (for details see lecture notes).
- Understand and appreciate the content and timing of drug development process steps, development phases and decision criteria.
- Understand the concepts underlying drug product development through all the phases from preclinical and clinical development to regulatory submission, approval and market launch.
- Can differentiate between small molecule drug development and biological drug development.
- Understand the most important differences between legal and regulatory requirements for drug development and approval for the major markets EU and USA.
ContentCourse unit comprises weekly lectures covering the early phases of target and drug discovery (535-0901-01 S "From A to Z in Drug Discovery and Development I") with group work in the area of Drug Development (511-0000-00 G). Group work is 2 full days (Days 1 and 2) and comprises: introduction to the entire suite of drug product development processes in the pharmaceutical industry, covering: preclinical research and development, clinical development, regulatory processes and market launch.
R&D support processes such as project management, quality management, pharmacovigilance and pharmacoeconomics will be covered as well as organizational and governance aspects of the pharmaceutical industry. In addition, important success factors for a later career in the pharmaceutical industry will be discussed and highlighted at the end of the course.
Lecture notesWill be published on "mystudies"
LiteratureG. Nahler (Hrsg.) Dictionary of pharmaceutical medicine, Springer, Wien, 2013 (3rd edition)
Further readings will be listed in the lecture notes.
Prerequisites / NoticeThis course provides the essential basic knowledge required for the industry-specific modules of the spring semester.

Safety conceptt: https://chab.ethz.ch/studium/bachelor1.html
511-0007-00LScientific Writing and Presenting Restricted registration - show details
Only for Pharmaceutical Sciences MSc.
O2 credits2GJ. A. Hiss, A. Burden, J. Dolenc, J.‑C. Leroux, O. Renn, C. Steuer
AbstractThis introductory class provides an overview of the basic scientific writing techniques and a guideline to presenting scientific data, together with guided exercises and hands-on training. It is devised to accompany the research projects within the curriculum of the MSc in Pharmaceutical Sciences.
Learning objectiveThe class enables the participants to prepare their own scientific texts and oral presentations, and critically assess the quality of the presentation of scientific data.
ContentThe participants receive an introduction to basic formal aspects of scientific writing and the design of graphical elements. Lectures and topical seminars alternate with practical task for the participants, which will be evaluated in a peer-to-peer setting. Performance feedback is provided by both the teachers and the peers.
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