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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We are looking for QA specialist

Insuvia 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…

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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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