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The most common and costly delays and failures in combination product development are due to misunderstood differences between drugs and devices. The two worlds have different cultures, paradigms, regulations, procedures, safety concerns, evidence requirements, timelines, budgets, and vocabularies. Companies too often move confidently forward, not knowing what they don’t know until it is too late. Higher costs and slower time to market can be disastrous.
This set of webinars convenes experts from drug, medical device, biologics, and diagnostics companies that have successfully developed and marketed combination products, and created systems to manage the process well. The programs cover those critical areas where errors and problems most often occur, and provide practical information on reconciling different requirements and procedures, and most efficiently managing the collaboration between the two business entities involved.
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