In pharmacovigilance, case processing is a fundamental activity. It provides data for the analysis of…

We are excited to announce that due to the high demand we will be repeating…

Pharmacovigilance is a vital part of the development of the new medicinal products. It makes…

Request the white paper “Outsourcing in Pharmacovigilance: Why and How?” With the development of new…

Join us for 2020 RQA International QA Conference on 10th-12th November! This year’s theme is ’20/20…

In pharmacovigilance, case processing is the fundamental activity that provides data for the analysis of…

An amendment to the Regulation (EU) 2017/745 (also known as MDR) was adopted on 24…

COVID-19 pandemic forced companies to explore how to survive while ensuring business continuity and protecting…

This is the new blog in our ‘Career Insights’ series and we spoke to Andrea…

On the 22nd of November 2017, the European Medicines Agency (EMA) launched a new version…

This is the third blog in a new ‘Career Insights’ series and we spoke to…

This is the second blog in a new ‘Career Insights’ series and we talk to…

This is the first blog in a new ‘Career Insights’ series and we talk to…

Leadership in the Workplace: Angela Weston International Women’s Day takes place on March 8th and is…

Verona, Italy (25 February 2020) – In response to the news from the Italian Authorities,…

Post-authorization studies (PAS): European & American approach Randomized trials are the gold standard in evaluating…

On the 10th of October the top industry professionals gathered in Madrid, Spain, for Regulatory…

Verona, Italy (11 September 2019) – PM Holding, a group of diverse service providers in…

Event titled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” will…

What is GCP GCP stands for Good Clinical Practice, a set of standards for designing,…

CROS NT, seQure and Arithmos have become a corporate partner and members of the women’s…

Digital Transformation and Industry 4.0 – these are the topics regularly featured in titles of…

We always aim at staying in close contact with the industry stakeholders and partners, so…

Many sponsors and  CROs conduct mock inspections to determine organizational inspection and audit readiness. Investing in…

The GDPR – General Data Protection Regulation entered into force in May 2018. This regulation supplants the…

At the end of 2017, as required by Italian Law No. 232/2016, AIFA approved new…

To commercialize and take a drug to market, pharmaceutical companies are subject to stringent regulations that…

In November 2017, the European Commission published a set of new guidelines on Good Manufacturing Practices (GMP) specific…

Pharmacovigilance activities have long been fundamental to companies seeking market approval in both the drug…

The new Clinical Trials Regulation n° 536/2014 was adopted in 2014. Due to technical difficulties…

The new ICH GCP E6(R2) addendum came into effect from June 14, 2017. The new addendum is the largest…

A Quality Management System (QMS) is a formalized system that documents processes, procedures, and responsibilities…

The new GDPR (EU General Data Protection Regulation) supplants the previous Data Protection Directive 95/46/EC, a formal…

Pharmacovigilance Market size is expected to exceed USD 8 billion by 2024; according to a new…

As of April 2017, the EU adopted the new Medical Device Regulation (MDR 2017/745), replacing…

Pharmacovigilance activities has long been fundamental to the pharmaceutical companies. As a result, demand for robust…

Computer system validation (CSV) is a documented process for assuring that a computer system does what it is…

Milan appears to be a top prospect to host the new EMA agency in Europe…

seQure Life Sciences takes a look at the eventual relocation of UK-based EMA Agencies. The…

Patients worldwide constantly expect new, effective and safe therapies. Access to modern drugs would not…

With the new ICH GCP E6(R2) addendum in effect from June 14, 2017, seQure Life…

seQure takes a look at the challenges that have occurred in the field of pharmacovigilance…

The FDA recently finalized guidance on safety data collection for late-phase and post-approval trials. With…

In order to ensure patient safety and comply with pharmacovigilance regulations, massive amounts of safety…

seQure Life Sciences presents the current pharmacovigilance legislation in Europe:

SEQURE takes a look at the concept of adverse event and possible criteria established by…