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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.
Bristol Myers Squibb is collaborating with non-profit organisation Disability Solutions on an initiative to increase diversity in clinical trials.
Global regulators commit to collaborate on the integration of real-world data and real-world evidence (RWE) in regulatory decision-making.
At its July meeting, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) recommended 11 medicines for approval and extended the indication of six more, including Imvanex for the prevention of monkeypox.
The draft Regulation aims to enhance the protection of donors and recipients of substances of human origin (SoHO) therapies, while facilitating supply and innovation.
The market for counterfeit pharmaceutical products remains strong, with dishonest actors proving perennially tenacious. Here, Rich Quelch offers guidance on the technologies and practices that are helping to impede fraudsters.
In this article, Samantha Lane of the UK’s Drug Safety Research Unit discusses the development of an evidence-based medicine (EBM) methodology to assess the positive impact of withdrawing or revoking licences for medicines on public health. The approach leverages electronic health records to model the estimated number of adverse reactions…
Ex-MHRA inspector and NSF expert, Rachel Carmichael, takes a high-level look at why Data Integrity matters in this online introduction training.
Report by One Health Trust says acknowledging antimicrobial resistance in regulatory frameworks for accelerated drug approval could improve access to new antibiotics.
The pilot will assess whether analysing raw clinical trial data is beneficial to regulatory decision making on marketing authorisation and post-authorisation applications.
Cold chain shipping challenges & root causes of common reference product sourcing problems.
Here EPR summarises the key points of Jeanne Moldenhauer’s article on what can be learned from warning letters and regulatory inspection observation reports.
Here EPR summarises the salient points of a case study, presenting a strategy for identifying worst-case sampling locations on equipment for cleaning validation.
Many quality control professionals recognise that the need to modernise microbial detection methods is at an all-time high.
With the focus on environmental, social and governance (ESG) issues rising worldwide, in this article, Morgan, Lewis & Bockius LLP Partners, Lesli Ligorner and Louise Skinner discuss the evolving landscape, presenting the emerging regulations for reporting social factors across Asia and Europe.
