Computer system validation (CSV) is a documented process for assuring that a computer system does what it is designed to do. Not performing certain computer system validations in accordance with Best Practices could be against the law. Both the EMA and FDA have rules and regulations in effect for GMP (Good  Manufacturing Practices), GLP (Good Laboratory Practices), GVP (Good Pharmacovigilance Practices) and GCP (Good Clinical Practices). seQure…

Starting on the 22nd of November 2017, new improvements and changes will affect users of the EudraVigilance system, such as National Competent Authorities, Marketing Authorisation Holders and Sponsors of clinical trials. The European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance with enhanced functionalities for reporting and analysing suspected adverse reactions….

Milan appears to be a top prospect to host the new EMA agency in Europe as the UK prepares to leave the EU. But what could this mean for the pharma industry? How could this influence their outsourcing strategies? At this time, we don’t have all the answers, but meanwhile, we can try to better understand…

seQure Life Sciences takes a look at the eventual relocation of UK-based EMA Agencies. The EBA and the EMA are two of the most powerful EU regulatory bodies. In April 2017, the European Union looked set to decide in October where to relocate the European Medicines Agency and the European Banking Authority, now based in…

Patients worldwide constantly expect new, effective and safe therapies. Access to modern drugs would not be possible without clinical trials – a significant element of the drug marketing authorization process. Clinical trial and post-market trials are the foundation of contemporary medical science and “pivotal” in the drug development process. They are a pre-condition of patients’…

With the new ICH GCP E6(R2) addendum in effect from June 14, 2017, seQure Life Sciences would like to highlight: “The importance of a quality management system managed through a risk-based approach”.  The new addendum is the largest revision of the ICH GCP Guidelines over the past twenty years and it is fully supported by the…

seQure takes a look at the challenges that have occurred in the field of pharmacovigilance following new ICH Guideline. Pharmacovigilance always provides new challenges. The recent change is the new E2B (R3). Further more, the exchange of security information has moved from paper to electronic format as a result of European regulation. Electronic submission is…

The FDA recently finalized guidance on safety data collection for late-phase and post-approval trials. With this announcement, the FDA has coined the term “Selective Safety Data Collection” and aims to provide guidance on when selective safety data collection is appropriate without undermining the importance of collecting sufficient data. The FDA has specified that “selective safety…

In order to ensure patient safety and comply with pharmacovigilance regulations, massive amounts of safety data must be collected and analyzed. SEQURE explains how automating pharmacovigilance systems can improve the identification of adverse events with real time results. Updates on Pharmacovigilance Legislation Regulatory authorities and governing bodies have been taking steps to improve patient safety. The…

seQure Life Sciences presents the current pharmacovigilance legislation in Europe:

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