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Biopharm International On Sept. 21, 2023, FDA released a new guidance on how the agency plans to utilize alternative tools to remotely evaluate drug manufacturing facilities identified in a marketing application. The application may be a new drug application, an abbreviated new drug application, a biologics license application, or a supplement to any of these […]

Applied Clinical Trials While many US-based biopharma start-ups are interested in conducting clinical trials in Europe, they are often unfamiliar with European legislation and regulations. Some of the biggest misconceptions are around start-up timelines. Typically, the time it takes to go from initial clinical trial application to delivering the first dose to a patient takes […]

International Biopharma As a result of centuries of carbon and other greenhouse gas (GHG) emissions from human industrial activity, the Earth is already about 1.2°C warmer than it was in the late 1800s. Worryingly, atmospheric CO2 levels continue to rise despite efforts over recent decades to address the issue. 1- To keep global warming under […]

19-20 February EUCROF24 will bring together pharma, biotech, medical device companies, CROs and other service providers, technology providers, regulators, patients, and academia, to discuss the current challenges, and future direction of Clinical Research across Europe. EUCROF24 is the 7th running of the EUCROF Clinical Research Conference that attracts a diverse range of speakers and attendees from functions including clinical operations, regulatory, data […]