Search result: Catalogue data in Spring Semester 2021
CAS in Pharmaceuticals - From Research to Market  | ||||||
 Modules | ||||||
| Number | Title | Type | ECTS | Hours | Lecturers | |
|---|---|---|---|---|---|---|
| 541-0001-00L | Module 1: Health System, Pharmabusiness and Marketing Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | W | 2.5 credits | 3G | 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 Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | W | 2.5 credits | 3G | R. Schibli | |
| Abstract | ||||||
| Learning objective | ||||||
| 541-0004-00L | Module 4: Health Communication Does not take place this semester. Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | W | 2.5 credits | 3G | R. Schibli | |
| Abstract | Health Communication Negotiation Presentation Power | |||||
| Learning objective | Basics of Health Communication Knowledge Management Internal and external communication Publich Relations (PR) Intercultural communication Crisis Management Communication with Health Authorities Social media | |||||
| 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. | W | 2.5 credits | 3G | R. Furegati Hafner, 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 Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. | W | 2.5 credits | 3G | R. Furegati Hafner, 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 | |||||
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