DRAP
The article provides a general overview of the pharmacovigilance system, highlighting the key points and aspects.
DRAP
The new article describes in detail the key aspects related to the Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
Australia
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.
Australia
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
