OPINION The recent updates from the IMDRF Working Group are a crucial step in the ongoing evolution of medical device regulation. As the healthcare landscape continues to change rapidly, it’s…
OPINION The recent voluntary withdrawal of the Global Harmonization Working Party (GHWP) from the International Medical Device Regulators Forum (IMDRF) raises significant questions about the future of global regulatory harmonization…
OPINION In an increasingly complex regulatory landscape, the importance of user-friendly training cannot be overstated. The upcoming PMS Product User Interface (PUI) training offers a timely opportunity for stakeholders to…
OPINION The increasing frequency of medicinal product shortages presents a significant challenge to healthcare systems globally. The upcoming meeting of the Executive Steering Group on Shortages and Safety of Medicinal…
OPINION The recent bilateral meeting between the European Medicines Agency (EMA) and the European Consumer Organisation (BEUC) underscores a pivotal shift in the pharmaceutical regulatory landscape. As consumer advocacy gains…
OPINION The role of non-clinical data in the regulatory landscape is often underestimated, particularly in the context of medical countermeasures. This upcoming workshop by the European Medicines Agency (EMA) highlights…
OPINION Medicine shortages pose a significant challenge to healthcare systems across Europe and beyond. The upcoming EMA public webinar represents a proactive step towards addressing this urgent issue by putting…
OPINION The upcoming workshop by the European Medicines Agency on the use of external controls for evidence generation highlights a pivotal shift in the regulatory landscape. Traditionally, regulatory decision-making has…
OPINION The upcoming HMA/EMA multi-stakeholder workshop on artificial intelligence represents a pivotal moment in the intersection of technology and regulatory frameworks within healthcare. As AI continues to evolve, it becomes…
OPINION The upcoming DARWIN EU Advisory Board meeting represents a significant opportunity for stakeholders in the pharmaceutical industry to engage with regulatory bodies. However, the efficacy of such meetings hinges…