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6th Annual SCOPE Europe: Summit for Clinical Ops Executives

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 […]

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FDA Releases Guidance on Using Remote Oversight Tools for Drug Approval

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 […]

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The EU Regulations Catching US Pharma Companies Off Guard

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 […]

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How can the pharmaceutical industry overcome barriers to reducing its carbon footprint?

September 29, 2023

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 […]

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