EU regulators have issued a new Q&A document on the key aspects that sponsors of complex trials should consider when making new submissions or moving ongoing studies to the Clinical Trials Information System.

The UK has finalized plans for delivering what it believes will be a stable and streamlined clinical trials framework following its departure from the EU. Transparency, patient involvement and diversity are high on the agenda.

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

The challenges posed by the implementation of the EU IVD Regulation are having a negative impact on medicine trials using diagnostics. Many of such studies are currently stalled and research-based drug companies are calling on all partners to engage in dialog to find an urgent solution.

The International Pharmaceutical Regulators Programme explains how manufacturers of cell and gene therapy products can assess and mitigate the potential risks associated with product raw materials.

An EU project for framing recommendations and best practices to improve cross-border access to clinical trials is gathering pace.