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 |
| 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 |