Progression in supporting development of precision medicine was noted as an achievement in a mid-term report on the EMA’s Regulatory Science Strategy to 2025.
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The European Medicines Agency (EMA)
With a growing number of therapies under development for rare diseases, ICON’s Dr William Maier discusses how real-world evidence (RWE) can be effectively used as a historical control (HC), overcoming challenges presented in clinical development.
In its latest meeting, the Committee for Medicinal Products for Human Use (CHMP) recommended 12 medicines for approval, including those for rare diseases, osteoporosis and cancer.
The latest workplan outlines how innovation in clinical research will be facilitated over the next four years, including modernising good clinical practice and issuing guidance on decentralised trials.
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 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…
The pilot will assess whether analysing raw clinical trial data is beneficial to regulatory decision making on marketing authorisation and post-authorisation applications.
With cardiovascular disease continuing to present a significant health concern, European Pharmaceutical Review’s Hannah Balfour reflects on recent development efforts and drug approvals in the space with comment from Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland.
Dave Elder looks at the guidelines drug manufacturers should follow to reduce nitrosamine impurities, following several recent withdrawals.