Search result: Catalogue data in Autumn Semester 2019
CAS in Pharmaceuticals - From Research to Market | ||||||
Modules | ||||||
Number | Title | Type | ECTS | Hours | Lecturers | |
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541-0002-00L | Module 2: Project Management in the Pharmaceutical Industry 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 | Pharma Project Management and Communication | |||||
Learning objective | Project Management Basics: -About projects, project management and the project environment -How to define and plan my project, how to deal with stakeholders and how to manage project risks -Managing my project team, developing the project plan and launching the project -Managing my project team, developing the project plan and launching the project -Monitoring and reporting, project close-out and project leadership -Project evaluation and portfolio management -Budget and resource management Workshop: -Development of a generic drug product in cross-functional project teams Communication: -Intercultural communication -Negotiation skills -Presentation power | |||||
541-0007-00L | Module 7: Clinical Development 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 | 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 |
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