Safety Data Reporting
| Authors | |
|---|---|
| Year of publication | 2024 |
| Type | Workshop |
| MU Faculty or unit | |
| Citation | |
| Description | The course focuses on safety data reporting in paediatric clinical trials, following Good Clinical Practice and Good Pharmacovigilance Practice guidelines. The reading material will introduce you to the topic and lead to the animated video lessons. The video lessons aim to capture the lively discussion that takes place among all interested parties, paediatric participants, their caregivers, and investigators but also sponsors, drug agency and Ethics Committee representatives, and patient advocates during the evaluation of a paediatric clinical trial. During the 4th week, a webinar will be held with all students to explore the topic more deeply. In addition, an online discussion forum will be available throughout the course to allow students interact with the teachers and among themselves easily. Programme: Week 1: Study of background material provided by the teachers; Week 2 and 3: interactive animated video-lessons; Week 4: webinar on the c4c VLE Platform – Tuesday, November 12th at 2:00 pm Week 5: final exam and certification. |
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