Journal of Pharmacovigilance

The pharmacovigilance outsourcing standard

9^th International Conference and Exhibition on Pharmacovigilance & Drug Safety

July 17-18, 2017 Munich, Germany

Bert P Van Leeuwen

Astellas Pharma, Netherlands

Posters & Accepted Abstracts: J Pharmacovigil

Abstract:

Outsourcing in pharmacovigilance has grown in the past decade. However, standards are lacking in this area, both for initiating as well as maintaining an outsource relationship. In this paper, the authors, from both pharma industry as well as service providers, propose that the sector can learn from other industries that have been outsourcing activities for a much longer time, such as the oil and gas industry. The safety case is put forward as a body of evidence that facilitates the continuous exchange of data, especially focused on risk management of the relationship between outsourcer and vendor. Currently, the authors are developing this standard for PV outsourcing through the Alliance for Clinical Research Excellence and Safety (ACRES) network.

Biography :

Email: bert.vanleeuwen@astellas.com