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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Local Person for Pharmacovigilance (LPPV) Strategy Considerations in the European Union

To ensure the safety of their products Marketing Authorization Holders (MAHs) must have well-developed pharmacovigilance (PV) system in place. The launch of the PV system in the European Union (EU) requires the designation of the EU-QPPV, a person responsible for establishing and maintaining the PV system. In addition to the EU-QPPV, part of the National Competent Authorities (NCAs) of the EU member states require MAHs to appoint a local contact person for PV issues at the national level (local…

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Requirements for nomination of a PV contact person at national level

Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders (MAH) must have an appropriate and qualified person responsible for pharmacovigilance (EU-QPPV) domiciled or located within the European Union. Also, the EU pharmacovigilance framework establishes the opportunity for the National Competent Authorities (NCA) of the EU to request the nomination of a contact person for pharmacovigilance (PV) issues at a national level.   Such individuals are typically…

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