395-0205-00L Development Process: Clinical
| Semester | Spring Semester 2024 |
| Lecturers | J. Goldhahn, M. Kalousek, I. Schauwecker |
| Periodicity | yearly recurring course |
| Language of instruction | English |
Courses
| Number | Title | Hours | Lecturers | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 395-0205-00 G | Development Process: Clinical | 17.6s hrs |
| J. Goldhahn, M. Kalousek, I. Schauwecker |
Catalogue data
| Abstract | Participants will be introduced into clinical development of medicinal products including diagnostics, medical devices, and drugs. They will learn how to develop a clinical strategy based on key characteristics of the product under development. Key considerations for supporting studies, endpoint development, and safety strategy will be discussed and applied. |
| Learning objective | Participants - understand the challenges to define a clinical development strategy - know the main elements of a clinical development plan - identify the necessary steps and stakeholders - generate a clinical development plan based on various cases |
| Content | • clinical strategies • GCP aspects in clinical studies • Patients as partners in development • Clinical development plan and Ph I-IV • Exploratory studies to support product development • preparation of a clinical development plan • Symposium Clinical strategy |
Performance assessment
| Performance assessment information (valid until the course unit is held again) | |
Performance assessment as a semester course | |
| ECTS credits | 3 credits |
| Examiners | J. Goldhahn, M. Kalousek, I. Schauwecker |
| 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
| Priority | Registration for the course unit is only possible for the primary target group |
| Primary target group | CAS ETH in Regulatory Thinking (391000)
MAS ETH in digital Clinical Research (395000) |
Offered in
| Programme | Section | Type | |
|---|---|---|---|
| CAS in Regulatory Thinking | Modules | O |  |
| MAS in Digital Clinical Research | Module Regulatory Thinking | W | |