541-0007-00L Module 7: Clinical Development
Semester | Autumn Semester 2019 |
Lecturers | R. Furegati Hafner, R. Schibli |
Periodicity | two-yearly recurring course |
Language of instruction | English |
Comment | Only for CAS in Pharmaceuticals. The enrolment is done by the CAS in Pharmaceuticals study administration. |
Courses
Number | Title | Hours | Lecturers | ||||||||||||||||
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541-0007-00 G | Module 7: Clinical Development Block course 03.09 .- 05.09.2019 10.09. - 11.09.2019 | 40s hrs |
| R. Furegati Hafner, R. Schibli |
Catalogue data
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 |
Performance assessment
Performance assessment information (valid until the course unit is held again) | |
Performance assessment as a semester course | |
ECTS credits | 2.5 credits |
Examiners | R. Schibli, R. Furegati Hafner |
Type | ungraded semester performance |
Language of examination | English |
Repetition | Repetition possible without re-enrolling for the course unit. |
Learning materials
No public learning materials available. | |
Only public learning materials are listed. |
Groups
No information on groups available. |
Restrictions
There are no additional restrictions for the registration. |
Offered in
Programme | Section | Type | |
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CAS in Pharmaceuticals - From Research to Market | Modules | W |