Safety Data Exchange Agreement (SDEA)

A Safety Data Exchange Agreement (SDEA) is a legal written contractual agreement between two or more parties that ensures that all necessary information on the safety of medicine reaches the marketing authorization holder (MAH) quickly and safely so that he can fulfill his legal obligations on time. It defines each party’s responsibilities in pharmacovigilance activities,…

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Insuvia opens a new office in Baku, Azerbaijan

Insuvia is delighted to announce the opening of our new office in Baku, Azerbaijan. The decision to open an office in Azerbaijan was based on the visible growth of the pharmaceutical market in the CIS region, changes in the legal framework and the willingness to assist prospective and existing life-science companies in this market by…

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Periodic safety update report (PSUR): overview for MAH

What is the Periodic Safety Update Report (PSUR)? The Periodic Safety Update Report (PSUR) is described as a pharmacovigilance document that is intended to provide an evaluation of the risk-benefit balance of medicinal products at defined time points after their authorization. The objective of the PSUR is to present a comprehensive and critical analysis of…

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Meet with us at DIA 2020 Virtual Global Annual Meeting

We are pleased to announce that Insuvia will participate in the DIA 2020 Virtual Global Annual Meeting. Despite the current situation around the world, we are glad to be able to meet you in a virtual way at the booth #132.   You can also schedule a meeting with us here.  Date: June 14-18th , 2020  About: For more than 50 years, DIA has provided the…

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