Many sponsors and  CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in a regulatory mock inspection demonstrates a serious commitment to patient safety, data integrity, and regulatory compliance. The primary goal of a mock inspection is to identify gaps prior to an actual inspection. Below, some tips to proceed in the right direction: 1) Put…

At the end of 2017, as required by Italian Law No. 232/2016, AIFA approved new criteria for the classification of a drug as innovative, the assessment procedures and the criteria to maintain the qualification of “innovative”. The criteria identified by AIFA are: 1) Therapeutic need: to be considered “innovative”, the therapeutic need can be classified…

To commercialize and take a drug to market, pharmaceutical companies are subject to stringent regulations that aim to protect the patients. This puts pressure on Sponsors to respect complex rules and regulate the entire “life cycle” of a drug – from development to authorization and post-market surveillance.During the last years, a lot of drug regulations came into effect in…

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…

The new ICH GCP E6(R2) addendum came into effect from June 14, 2017. The new addendum is the largest revision of the ICH GCP Guidelines over the past twenty years and it is fully supported by the European Medicines Agency (EMA). Previously, these guidelines were optional and the addendum now makes mandatory some activities related to Quality Management. With…

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A Quality Management System helps to coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis. Implementing a quality management system affects every…

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…

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