Jointly organised by BBMRI-ERIC, EJP Rare Diseases, EASI-Genomics, BBMRI.at, CBmed GmbH and QIAGEN GmbH
Hosted by the Medical University of Graz, Austria
This workshop is aimed at biomedical researchers, medical professionals, representatives from patient organisations and biobank managers who want to organise biomedical research projects on human biological samples.
In two modules we will use several use-cases to address the key issues in biomedical research involving human subjects, human biological samples and associated medical data: ethics, legal issues, privacy and data protection, data standardisation and the implementation of sample workflows in a clinical context that are compatible with the In Vitro Diagnostic Regulation.
In the first module, we will show participants how to obtain ethical, legal and regulatory counsel for their projects since regulations vary widely between European countries. In addition, we will provide practical guidelines on how to manage genetic data from human samples. The goal is to arrive at a logically organised checklist that prevents overlooking important issues that may be particularly challenging, e.g. in transnational collaboration. The second module will deal with procurement of samples and data in a workflow in a clinical context aligned with current CEN/ISO standards for pre-analytical procedures.