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…
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…
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…
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…
DetailsUnder 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…
DetailsAs confirmed by Senior Inspector, Kiernan Trevett, at the MHRA GPvP Symposium, the MAHs must appoint a UK QPPV within 21 months of the end of the Brexit transition period..
DetailsThe World Drug Safety Congress Americas is the most senior-level, industry focused event for the pharmacovigilance community globally. With over 30 countries represented..
DetailsStarting from July 2019, “Insuvia”, UAB began implementing a project called “Insuvia Export Development”, partially financed by the European Union. The aim of the project is to increase the export of services to existing and new markets.
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