Esas deliverable ps 1123 customer survey on code generations in safety critical applications by ewen denney and johann schumann get pdf 7 mb abstract automated code generators acg are tools that convert a higher level model of a software sub system into executable code without the necessity for a developer to actually implement the code although both commercially supported and . O safety issues published in the scientific and medical literature o safety issues arising from the signal detection activities see module ix 2 esi emerging safety issues examples 2 2 examples include contd o signals of a possible teratogenic effect o safety issues related to the use within or outside the terms of the marketing authorisation o safety issues due to . All relevant clinical and non clinical safety data should cover only the period of the report interval data with the exception of regulatory status information on authorisation applications and renewals as well as data on serious unlisted adrs see below 145 which should be cumulative
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