Abstract
The purpose of this review is to increase readers' knowledge and raise awareness of pharmacovigilance licensing in international drug safety departments and in departments that deal with licensed products. In order to succeed, pharmaceutical companies must have a global presence and be large organizations. Constant growth can rarely be generated from a company's own product-pipeline; thus, licensing is necessary in order to fill the gap. Acquiring an internationally marketed product or merging with a company that has several products on the market has a significant impact on cost and resources within a pharmacovigilance department.
The activities of the international pharmacovigilance department are:
Initial safety assessment (due diligence) on the product(s) to be acquired, Exchange of information regarding drug safety business practices (data handling, standard operating procedures), Due diligence on the pharmacovigilance system, Support of information services during migration of the pharmacovigilance system, Establishment of a transient data exchange procedure, Transfer of reporting obligations on a country-by-country basis, and Transfer of source documents.
The transient data exchange procedure should be annexed to the main agreement. The type of data to be migrated and the ownership/archiving of drug safety data should also be clearly specified in the main agreement.
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