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 DDPS/PSMF. If the advisor finds topics that may not be audit-proof, DADA can assist the client with updating the pharmacovigilance system to match competent authorities expectations and legislation.
DADA may also be consulted during the establishment of a pharmacovigilance department within 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.