395-0205-00L Development Process: Clinical
| Semester | Frühjahrssemester 2024 |
| Dozierende | J. Goldhahn, M. Kalousek, I. Schauwecker |
| Periodizität | jährlich wiederkehrende Veranstaltung |
| Lehrsprache | Englisch |
| Kurzbeschreibung | 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. |
| Lernziel | 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 |
| Inhalt | • 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 |