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…
DetailsThe 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,…
DetailsMeet us at the World Orphan Drug Congress Europe 2020. Despite the current situation around the world, we hope you’ll join us in the virtual platform created for this meeting. You can also schedule a meeting with us here. Date: November 2 – 5th. About: The World Orphan Drug Congress Europe 2020 is an award-winning event…
DetailsA 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,…
DetailsMeet us at the World Drug Safety Congress Europe 2020 virtual event. 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. You can also schedule a meeting with us here. Date: October…
DetailsMeet us at the CPhI Festival of Pharma 2020 virtual gathering. 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: October 5 –16th, 2020 About: CPhI Festival of Pharma is a virtual gathering launched to…
DetailsInsuvia 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…
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…
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