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…

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…

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…

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…

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…

The new Clinical Trials Regulation n° 536/2014 was adopted in 2014. Due to technical difficulties in the development of computer systems, the “go live” date of the Portal was postponed and the EMA Board of Directors will identify a new date once the provider confirms the resolution of the issues. Therefore, the EU Clinical Trials…

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…

The new GDPR (EU General Data Protection Regulation) supplants the previous Data Protection Directive 95/46/EC, a formal set of guidelines concerning data privacy. The premise of the new regulation is to bring into line data privacy laws throughout Europe, while safeguarding the rights of EU citizens. Crucially, the GDPR aims to alter the way organizations handle and…

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