Organisation set-up and changes

For clients who conduct their own pharmacovigilance activities, DADA may function in an advisory role to review the pharmacovigilance system as described in the client’s PSMF. If DADA finds topics that may not be inspection-proof, DADA can assist the client with updating the pharmacovigilance system to match Competent Authorities’ expectations and legislation.

DADA may also be consulted for advice during the establishment of a pharmacovigilance department at the client, to assist in determining the necessary new communication channels and responsibilities of those departments that will need to interact with the pharmacovigilance department and provide organisational advice if needed.