
EDA Guidance on Preclinical Testing and Clinical Investigations: Clinical Investigation Explained
The new article explains the approach to be applied with respect to clinical investigations.
The new article explains the approach to be applied with respect to clinical investigations.
The new article provides further clarifications regarding the design of a clinical study, as well as the risk management approach to be followed.
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.
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.
The new article describes in detail the current structure of the pharmacovigilance programme implemented in Pakistan.