Requirements for a Local Person for Pharmacovigilance (LPPV) in the Eurasian Economic Union (EAEU) and the rest of CIS countries

The pharma markets in the Eurasian region are among the fastest growing and most commercially attractive markets for pharmaceutical and life sciences companies. The extremely high interest of pharmaceutical companies in these markets can be explained by the large region population (which is over 290 million), in proportion to the growing annual GDP, and, as well as the free market economy of EAEU. However, pharmaceutical companies seeking to reap the region’s benefits need to…

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Regulatory Affairs Outsourcing: benefits, models, tasks and future perspectives

The pharmaceutical market is rapidly evolving and changing. Many pharmaceutical companies are facing cost pressures and workforce spin. Recent trends show that it is much more difficult to obtain new Marketing Authorisation approvals, maintain regulatory compliance, and ensure competitive staff operating costs. Furthermore, a major problem that many pharmaceutical companies identify, is the inability to address local regulatory issues and…

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Insuvia is opening a new office in London

We are pleased to announce the opening of our new office in London, United Kingdom, as a step to extending our reach and local presence as part of an ambitious long-term growth strategy.   The new office opening in the United Kingdom will further strengthen our presence in one of the largest and most important…

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BREXIT – Key changes in the pharmacovigilance system

      The United Kingdom (UK) has left the European Union (EU), and the transition period after Brexit will come to an end on 31 December 2020. By the end of this transitional period, the legal framework will change, affecting all involved parties. To address this, during November 2020, the MHRA provided several documents that serve as guidelines to help affected parties, especially Marketing Authorization Holders (MAH) in the whole UK,…

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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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