Pharmacovigilance and Digital Transformation: Growing Role of Technology Digital Transformation and Industry 4.0 – these are the topics regularly featured in titles of Life Sciences events and publications recently. While we talk a lot about technologies that disrupt drug development, clinical trials, and pre-clinical stage processes, it is difficult to come across materials dedicated to…

We always aim at staying in close contact with the industry stakeholders and partners, so this October we traveled to Bologna, Italy for the Meet in Italy for Life Sciences conference, the leading national matchmaking and update event on Life Sciences. The Life Sciences sector in Italy is a crucial growth industry in Italy: the…

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…

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…

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…

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