Sean Schofield

Sean Schofield is Senior Regulatory Affairs Specialist, PPD, Part of Thermo Fisher Scientific.

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    Controlled substances development – past, present, and future


    Controlled substances present unique challenges and extra regulations compared to their non-controlled counterparts. Over time in Europe and the US, governing bodies have continually increased the burden on sponsors to demonstrate safety and efficacy. This includes legislation specific to controlled substances; dictating how they can be stored, destroyed, labeled, administered, ...