Early phase trials are different! Although classified as clinical trials in healthy subjects or patients that are principally conducted under GCP-standards, due to the experimental setting also GLP aspects need to be considered for this kind of trials and their quality management requirements – a challenging demand for investigators and study nurses but also for sponsors and auditors as well as inspectors, not least because of the responsibility for subjects’ safety.
In the meantime, this often applies not only to first-in-human, bioequivalence and PK-studies but also to phase-II-proof-of-concept trials.
Join our 2-days-workshop on Quality Management in Early Phase Clinical Pharmacology Units to learn about the principles of Quality Management Systems (QMS) to be established by CROs and university research institutions. These QMS principles are illuminated from the perspectives of experienced QM-managers from CPUs, sponsors and by inspectors from the European Union.
Consequently, our workshop addresses professionals working in the field of clinical trials at Sponsor-CPUs, CROs, and university hospitals as well as sponsors selecting CPUs and representatives of authorities.
The first day shall serve as training workshop to improve your knowledge about Quality Management Systems including quality assurance activities, training, standardisation of processes as well as error management and continuous improvement procedures in early clinical trials. Furthermore, site selection criteria to ensure data quality and integrity as well as subjects’ safety and vendor management in consideration of early phase trial characteristics will be discussed.
The second day shall focus on findings from audit and inspection activities to improve awareness for the necessity of a thoughtful Quality Management System. And – very important – the knowledge about difficulties and findings is very helpful to develop solutions and implement adequate Quality Management Systems at sponsor’s and CPU´s sites that could help to prevent not only errors and fatal mistakes but also systematic misconduct and even fraud.
