Pharmacovigilance Licensing: the Role of Drug Safety in Product Transfers
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667-671, 2002 the USA. All rights reserved.
Dm8 Iiifomliufi Journal, Vol. 36. pp.
Printed
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PHARMACOVIGILANCE LICENSING: THE ROLE OF DRUG SAFETY IN PRODUCT TRANSFERS MARTINKARLFRIEDRICH BECKER,MD, PHD Associate Director, Global Drug Safety and Surveillance, Solvay Pharmaceuticals. Hannover, Germany
The purpose of this review is to increase readers' knowledge and raise awareness of pharniacovigilance licensing in international drug safety departments and in departments that deal with licensed products. I n order to succeed. pharmaceutical companies must have a global presence arid be large organizations. Constant growth can rare1.v be generated from a company 's own product-pipeline; thus, licensing is necessciry 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 phurniacovigilance department. The activities of the international pharniacovigilance department are: Initial safety assessment (due diligence) on the product(s) to be acquired, Exchange of informrition 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 exchunge procedure, Transfer of reporting obligations on a country-by-country basis. arid Transfer of source documents. The transient data exchange procedure should be unnexed to the muin agreement. The type of data to be migrated and the on,nership/arclzivitig of drug safety dutci shoitld also be clearly specified in the m i n agreement. Kev Words: Pharrnacovigilance: Licensing: Drug safety
INTRODUCTION THE PHARMACOVIGILANCE department usually learns about a product acquisition after the product has been acquired or, when department staff members are lucky, within a month of the signing of the contract. Thus, the pharmacovigilance department must
Reprint address: Martin Karl Friedrich Becker. MD. PhD, Associate Director, Global Drug Safety and Surveillance, Solvay Pharmaceuticals, Hans Btxclilcr Allee 20. D-30173. Hannover. Gerniany (e-rnail: [email protected]).
work fast to make the necessary arrangements in time. These activities can be divided into four core areas:
1. Due diligence on the safety ofthe product: During due diligence, the pharmacovigilance department must rule out the possibility that the product produces severe adverse drug reactions. It is helpful to liaise with colleagues in the clinical and preclinical departments regarding early warnings. The pharmacovigilance department should complete an assessment report before the legal agreement is signed,
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Martin Karl Friedrich Becker
2 . A procedure for the exchange of safety information during the transition: This procedure should determine who is responsible for: the global pharmacovigilance database (incl
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