Can your organization be one hundred percent compliant in one hundred percent of its business locations? That is a very high bar and one few companies can meet. Is attempting to do so feasible or even desirable? The challenges of simultaneous compliance with US, EU and other national regulations, the role of the EU ‘legal representative’, the differing roles of CROs, and the expectations of investigator sites in different jurisdictions and cost containment will be analyzed in the interactive discussion.
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