Meet us at the BIO Europe Spring Digital 2021

Meet us at the BIO Europe Spring Digital 2021 You can schedule a meeting with us here. Date: March 22-25, 2021 About: BIO-Europe Spring is the premier springtime partnering conference bringing together a “whoʼs who” from biotech, pharma and finance in the most innovative biopharma clusters in Europe for high-level networking, pre-scheduled partnering meetings, strategic…

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We are attending the DIA Europe 2021

Meet us at the DIA Europe 2021 virtual conference. You can schedule a meeting with us here. Date: March 15 -19th, 2021 About: DIA Europe is the event for all life-science professionals working in drug development, from discovery to marketed use. It gives an opportunity to open new collaborations by bringing together representatives from the…

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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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