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Optimizing product development to ensure commercial success. Briefing Book or briefing materials Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation to a proposed drug development pathway. Document containing information and results generated in conducting an evaluation of the clinical safety and performance of a medical device. The effect that something is likely to have on the treatment of a particular group of people, or on the results of treating that group. Create clinical and regulatory documents to support all stages of your drug and device development. A core reimbursement dossier is submitted during the late stage of development of a product, in order to be considered for reimbursement. In order for health authorities to monitor the safety of investigational drugs, sponsors of clinical trials are required to submit safety reports of certain adverse events that occur during their clinical trials. The observed discrepancy between effects of a health intervention in routine clinical practice as compared with the effects demonstrated in randomised controlled clinical trials. It should contain company questions, justifications or company positions, and appropriate summary information.

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