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September 29, 2023

17-18 Oct 2023 Building on the success of its long-running US-based counterpart, the 6th Annual SCOPE Europe: Summit for Clinical Ops Executives is a two-day executive conference serving clinical innovation leaders, clin ops execs, digital leaders, functional heads, category managers, and those responsible for the planning and management of clinical trials in Europe and the […]

September 29, 2023

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 […]

September 29, 2023

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 […]