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well thank you for letting me discuss a key part of pharmacovigilance with you the risk management plan I will give you a short introduction then I will focus on the risk management plan of the new legislation and I will end my presentation with some points to consider so the end of the clinical trial period is a good point for me to start the presentation and the picture already shows it to you what do we know at the end of the clinical trial period in the sense of the safety profile of a product well it's a tip of the iceberg and this has to do with the inclusion exclusion criteria in a clinical trial and the small population of this clinical trial so rare adverse events will not be picked up in the clinical trial period and also the population of the clinical trial will not reflect the population that will use the product after authorization so approval of a product is a critical juncture in which we will start the life cycle of the product and we will try to pursue and manage the e

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