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we can give you an overview of the eu clinical trials regulation and there will be some highlights here and karim and kelly will go into a lot more detail in a few slides time okay next slide please so what is it whats new this is the key point really sort of the number of take-home messages here weve got a single entry point based on article 80. theres a new scope were looking at not only interventional but also low interventional clinical trials as well there are a number of new documents and new data types to be submitted there from lay summaries the interim results statements inspection reports from a third party and obviously copies of advertising materials statements on data protection more importantly there are new templates for existing documents which are going to require a number of changes theres new timings and theres new data that needs to be submitted from the first date of recruitment to end of recruitment to bdocHubes all of that theres also new timing for the tri
