The withdrawal of several high-profile pharmaceuticals from the market and some well-publicized problems with a number of medical devices have greatly magnified public concerns about the safety and efficacy of therapeutic products. The new administration in Washington is pushing for government-funded comparative effectiveness studies. CMS and private payors are more reluctant than ever to offer reimbursement for “me-too” products. Non-inferiority isn’t good enough anymore.
The FDA has grown more cautious and, as drugs increasingly target intractable diseases and medical devices become more complex, clinical trials have lengthened, slowing all-important time-to-market. Consequently, post-release monitoring is increasing markedly, requiring companies to be able to respond to concerns more quickly.
In this demanding environment with the well-being of patients and hundreds of millions of dollars at stake, developing outstanding regulatory leaders has never been more important – or more difficult. With demand for capable, committed regulatory leaders now outstripping supply, companies face a new regulatory dilemma: finding and building the talent to lead one of their most critical functions.
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