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 | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |
|---|---|---|---|
| CAS in Pharmaceuticals - From Research to Market | Modules | W |  |