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The Group plans to deliver a data quality framework by the end of 2022 and publish a public catalogue of European real-world data by 2025, among other actions.
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
The pilot will assess whether analysing raw clinical trial data is beneficial to regulatory decision making on marketing authorisation and post-authorisation applications.
Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need to ensure data integrity in life sciences. She explains how data integrity can reduce costs and increase patient safety across five key areas: reproducibility, IDMP, the microbiome, semantic enrichment, artificial intelligence and machine learning.
Cleanroom and laboratory managers need to collaborate to set their employees up for success. They must also be willing to review their procedures even when it seems an employee is responsible for an error.
Welcome to European Pharmaceutical Review’s Guide to Data Integrity. In this edition, Anca Ciobanu, Strategic Theme Lead at the Pistoia Alliance, discusses the need for data integrity in life sciences and how costs can be reduced but patient safety increased, and Charles River showcase their services and how they stand…
Here, Andrew Mitchell of IQVIA outlines the six stages of pharmacovigilance case automation, exploring how implementing intelligent automation such as AI and ML could benefit pharmaceutical companies.
Sanofi announces first Digital Accelerator to develop products and solutions that foster the use of digital, data and artificial intelligence.
The EU’s identification of medicinal products (IDMP) standards implementation was all set to go ahead, when the EMA suddenly announced a change of plan. The DADI user interface will now enable structured data submissions for the EMA PMS, at least for the near future. Drawing on recent dialogue with the…
A data collection study provides a product quality dataset that could form the basis of advanced analytical models to predict final product quality.
6 June 2022 | By Medable
Learn about the common misconceptions surrounding eConsent, as well as the benefits they can realise through a digitally-enabled approach.
Following a successful pilot in 2021, Sanofi and McLaren Racing have decided to extend their collaboration across multiple sites in seven countries, covering more than 100 production lines, across all technologies.
Targeting medicines against the genetic and molecular drivers of lung, breast and other tumours has helped transform cancer care for many patients, yet precision medicine for complex chronic diseases has lagged behind. Maria Orr, Adam Platt and Ben Challis, from BioPharmaceuticals R&D at AstraZeneca, explain why this is changing for…
Research suggests companies are often disappointed by new technologies because they have inflated expectations that do not match the tech's practical capabilities.
Four Big Pharma companies have shared previously unpublished hazard data for drug substances to enhance database-dependent computational tools and help reduce animal testing.
