OVERVIEW Within the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) assesses the applicant’s quality, safety and efficacy data deciding on whether to recommend marketing authorization to the EMA. 31 members: One representative from each EU member nation (28 voting members), plus 3 non-voting members…

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In my last post, I discussed the role that contextual intelligence (CI) (understanding stakeholder emotions, behaviors, and beliefs) plays in the collaborative and transparent communication of a product’s value.

But how do pharmaceutical and device teams use CI to successfully communicate in an increasingly complex healthcare environment – one currently defined by a growing number of powerful, vocal, and sometimes competing stakeholders? In this post, I explore practical ways to leverage the information from CI to achieve consensus among conflicting stakeholder

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As someone who spent the last seven years working at the Center for Devices and Radiological Health (CDRH), I can tell you that the underlying relationship between your company and its review division really matters – from submission, through a potential Advisory Committee meeting and beyond to your medical device…

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