Pharmacovigilance Agreement Definition

The main objective of the pharmacovigilance agreement is to define a mechanism to ensure the flow of customer safety information to the relevant authorities via mah. In order to achieve this objective, it is the responsibility of the POC to assess trade agreements and determine whether the terms relating to counterparty PV obligations are sufficient to ensure the proper execution of activities. On the basis of this assessment, it is necessary, if necessary, to establish an autonomous agreement on the routes for which the duration of the last batch of the affected products put on the market should be very late. Nor should this period of effect be met at the end of the trade agreement concerned. Beyond death, each of these categories is subject to a certain interpretation. The risk of death, as used in the world of drug safety, is specifically related to an adverse event that exposes the patient to an immediate risk of death, such as cardiac or respiratory arrest. According to this definition, events such as myocardial infarction, which could endanger life-threatening conditions, would not be considered life-threatening if the patient is not in cardiac arrest after IMD. Although generally simple, hospitalization may occur, even if the events treated are not serious. Similarly, severe events can be treated without hospitalization, as treatment of anaphylaxis can be performed successfully with adrenaline. Significant disabilities and inability to work as a concept are also discussed. While a permanent disability after a stroke would undoubtedly be severe, would "total blindness for 30 seconds" be considered a "significant disability"? In cases of birth defects, the severity of the event is generally not as controversial as the assignment of the event to the drug. Finally, "medically significant events" are a category that includes events that can always be serious or sometimes serious, but do not meet any of the other criteria. Events such as cancer can still be considered serious, while liver diseases, depending on their CTCAE (Common Terminology Criteria for Adverse Events), grade 1 or 2 are generally considered non-serious and of severe grade 3-5, cannot be considered serious.

[9] There may be situations in which an agreement is not necessary. B, for example, if the wholesaler does not have a contractual relationship with the MAH and is not considered a potential source of safety information and therefore would not be part of the MAH`s pharmacovigilance system. Since this agreement is binding on all partners, the legal department should review and approve the document.

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