DRAP Guidelines on National Pharmacovigilance System: Indicators
The final article of the cycle provides additional details regarding specific indicators used in the context of a pharmacovigilance system.
The final article of the cycle provides additional details regarding specific indicators used in the context of a pharmacovigilance system.
The new article elaborates further on the existing types of surveillance, highlighting the key points associated thereto.
The new article provides an overview of the regulatory procedures associated with the changes to sponsorship in the context of medical devices intended to be marketed and used in Australia.
The new article describes the approach to be applied with respect to mandatory recalls initiated in order to avoid the customers’ exposure to healthcare products that could potentially be harmful when used for the intended purpose.
The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA
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