Pharmacovigilance is the process of detecting, tracking, analyzing, and preventing negative side effects of drugs. Pharmacovigilance allows manufacturers and regulators to continue studying drugs and their effects after the drugs are released. With the global pharmaceutical market worth over $1 trillion and growing at a projected cumulative annual growth rate (CAGR) of 6% from 2014 to 2020, added to the increasing…

In November 2017, the European Commission published a set of new guidelines on Good Manufacturing Practices (GMP) specific to advanced therapy medicinal products (ATMPs).  Below, seQure Life Sciences created a summary about the new New Guidelines on Good Manufacturing pratices for advanced therapies: To download our infographic, click here. seQure is a niche services provider operating in the Life Sciences…

As of April 2017, the EU adopted the new Medical Device Regulation (MDR 2017/745), replacing the two existing directives, the Medical Devices Directive and the Active Implantable Medical Devices Directive: Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002…

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