At this BASG meeting, we will inform you about current and future developments in the field of clinical trials of medical devices and performance studies of in-vitro diagnostics.
Contents
- Studies according to the Medicinal Products and Medical Devices Act ("combination studies")
- Studies with "combination products"
- National aspects of the application process
- Update on the EUDAMED module for clinical trials/performance studies
- Information from the European working groups
- Exchange of experience and discussion
Target group
- Employees of regulatory affairs departments of manufacturers of medical devices or in-vitro diagnostics
- Employees of contract research organisations (CRO) and self-employed persons
- Employees of coordination centres for clinical trials (KKS)
- Academic researchers
Language
German
Registration information
Please register by 10.09.2024 at the latest.
This event will be held as an online-only event .
Technical management and lecturers
Dr Stefan Strasser
Clinical Trials Department, Institute for Surveillance
stefan.strasser@ages.at
Medical Market Surveillance Business Unit, AGES GmbH