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In this article, Dr Ronan Brown, IQVIA’s SVP and Head of Integrated Global Compliance, explores the long-term impact of COVID-19 on regulatory practices in three key areas: clinical trial study design, clinical trial study development and post-clinical trial regulatory submissions.
Global mergers and acquisitions (M&A) activity last year was expected to decline from 2019 levels, mainly due to the COVID-19 pandemic and resulting uncertainty around the global economy, trade tensions between the US and China, and the presidential election in the US. However, James Baillieu from Bird & Bird reveals…
GEA’s digitally-enabled process optimisation tools improve the customer experience and expedite the successful completion of pharmaceutical research, development and production projects. This comprehensive suite of process simulations, digital twins, augmented/virtual reality systems and remote support solutions represents a safe and effective environment in which to achieve operational excellence, expedite FATs,…
A new report suggests artificial intelligence (AI) will be the most disruptive technology in the pharmaceutical industry this year and beyond.
By digitalising manual workflows and leveraging machine-learning algorithms to monitor events and offer data-driven insights, automation and AI can make regulatory information management (RIM) more effective and less time-consuming.
In this article, William E Weiser discusses the advantages global pharmaceutical developers and manufacturers can gain from a laboratory information management system (LIMS) solution and highlights the key considerations to be made when integrating and standardising LIMS in their organisations.
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts.
Watch the webinar that analyses the most important points introduced by the newest USP Chapter 1085 on endotoxin testing guideline and their impact.
Regulatory operations are burdened by resource-draining document and data processing tasks, but is robotic process automation the definitive solution? If not, where does it have greatest application and appeal – and how can life sciences firms exploit the full benefits? Agnes Cwienczek scrutinises the technology’s potential.
AJ Ploszay, IQVIA’s Vice President of Digital Strategy, discusses how COVID-19 has accelerated digital transformation and driven the adoption of digital detailing.
Researchers have developed Metabolite Translator, a system that can predict what the in vivo metabolites of a drug could be in order to identify its potential toxicity.
Kiran Chinnalla and Julian Backhouse explain why automation for labelling in pharma can help the industry to remain compliant in the face of regulatory changes.
AUC was used to probe the effect of insulin concentration and the zinc chelating agent EDTA on monomer, dimer, and hexamer formation of USP Human Insulin Standard.
The rapid evolution of the COVID-19 situation has created significant barriers to normal operations, from locking down borders to the imposition of restrictions on trade and export – not to mention a surge in demand for many common medicines. Each of these events in isolation can affect production and supply,…
Andrew Dunbar outlines five digital technologies that can help pharma function to the best of its abilities over the course of the COVID-19 pandemic.
