Sr Consultant & CRO Service lead Qserve Group B.V., Netherlands
Getting more clinical data has been talked about in Europe for a decade now, since the talks started on the ‘recast’, ultimately culminating in the MDR that is rapidly getting into full force. One of the core reasons behind the legislative update was to reinforce the rules on clinical evidence and strengthening of post market surveillance requirements for manufacturers. After having ignored the issue for a few years, many manufacturers moved to schedule large clinical trials, only to get to a realization that this could turn out to be unaffordable, and products would have to be removed from the EU market. In recent years the search has focused on the middle ground: finding cost effective ways and tools to create clinical data, and alternatively to just collect clinical data and turn them into clinical evidence. This workshop will guide you trough the benefit and pitfalls encountered in this middle road to clinical safety.
PMCF: Understanding its aim under MDR and options for doing PMCF with their related value
IIS/IIT were common under MDD. Pros and cons and the valuable under MDR
ISO14155 GCP. The role and value of GCP. GCP compliance in practice. Consequences of incompliance
Strategy and planning not to be underestimated. Focus is often too early on operational parts without good considerations
Sites and site relationships to be build and maintained