The GDPR – General Data Protection Regulation entered into force in May 2018. This regulation supplants the previous Data Protection Directive 95/46/EC, a formal set of guidelines concerning data privacy. The premise of the new regulation was to bring into line data privacy laws throughout Europe, while safeguarding the rights of EU citizens. GDPR also establishes both general…

Pharmacovigilance activities have long been fundamental to companies seeking market approval in both the drug and device development process. For this reason, many companies decide to outsource some of the their tasks in order to improve efficiency in managing their Pharmacovigilance Systems. However, once you know what functions and expertise you want to keep in-house…

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…

Pharmacovigilance Market size is expected to exceed USD 8 billion by 2024; according to a new research report by Global Market Insights, Inc. Growing number of adverse drug reactions (ADRs) coupled with increasing prevalence of chronic diseases will drive global pharmacovigilance market size. Below a snapshot from today to 2024: To download our infographic, click here. Continue…

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…

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’…

seQure Life Sciences presents the current pharmacovigilance legislation in Europe:

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