不良事件、严重不良事件的报告和处理.ppt

* These criteria have been laid down by the Regulatory Agencies world-wide e.g. the International Conference on Harmonization; Medicines Control Agency (UK); Food and Drug Administration (US). ‘Other significant medical event’ includes any medical event that may jeopardize the patient or may require intervention to prevent one of the outcomes listed above e.g. drug interaction, abnormal laboratory findings which indicate serious vital organ dysfunction with or without clinical symptoms, which is moderate or severe in nature and which could require inclusion of a precautionary statement or cont