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…
DetailsMeet us at the World Drug Safety Congress Americas 2020 virtual event. Despite the current situation around the world, we hope you’ll join us in the digital realm of this meeting. You can also schedule a meeting with us here. Date: September 1st – 2nd, 2020 About: the World Drug Safety Congress Americas 2020 is the…
DetailsInsuvia is looking for a Senior Pharmacovigilance (PV) Specialist to join our team in Lithuania. As part of the Senior PV Specialist role, the person would act as the European Union Qualified Person for Pharmacovigilance (EU-QPPV) for some of our PV clients. Main Tasks and Responsibilities Act as EU-QPPV or Deputy EU-QPPV within assigned…
DetailsInsuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services. Currently, we are looking for a Quality Assurance Specialist to join our rapidly growing team in Lithuania. Main Tasks and Responsibilities Promote quality achievement and performance…
DetailsUntil December 31, 2025, the Eurasian Economic Union (EAEU) which consists of Russia, Belarus, Kazakhstan, Kyrgyzstan, and Armenia shall form a single market for medicines. One of the most important milestones in the process of formation of a single pharmaceutical market of the Eurasian Economic Union (EAEU) is the deadline for bringing the Dossiers into…
DetailsWhat 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…
DetailsIn this article we will be discussing requirements for nomination of a local QPPV in the Nordics (Denmark, Finland, Iceland, Norway and Sweden). Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders (MAHs) must have an appropriate and qualified person responsible for pharmacovigilance (EU-QPPV) domiciled or located within the European Union. Also, the EU pharmacovigilance…
DetailsMeet us at DIA Europe 2020 virtual conference. We hope you’ll join us in the digital realm of this meeting. Despite the current situation around the world, we are glad to be able to meet you in a virtual way at booth #C5. You can also schedule a meeting with us here. Date: June 30…
DetailsWe 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…
DetailsTo 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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