EDA
The new article provides further clarifications regarding the design of a clinical study, as well as the risk management approach to be followed.
EDA
The new article pays special attention to combination products as a separate category of medical devices, and also highlights the key points related to ethical considerations.
EDA
The new article explains in detail the approach to be followed with respect to safety reporting in the context of clinical investigations conducted in order to assess the safety and effectiveness of medical devices intended to be marketed and used in Egypt.
DRAP
The new article describes in detail the current structure of the pharmacovigilance programme implemented in Pakistan.
DRAP
The new article describes in detail the key aspects related to the Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
DRAP
The new article outlines the main stakeholders of the pharmacovigilance system and highlights the key points associated thereto.
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