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Quality Compliance & Regulatory
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17 Best Practices
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Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Health Care; Chemical; Biopharmaceutical; Clinical Research; Laboratories
Amylin; Astellas; AstraZeneca; Bayer; Boehringer Ingelheim; Cubist; Daiichi-Sankyo; GE Healthcare; Genentech; GlaxoSmithKline; IDEA Pharma; Integrated Diagnostics; Merck; Millenium; Novo Nordisk; ProStraken; Purdue; Sagent; Sanofi; Shionogi; Shire; Smith & Nephew
Federal Ecosystem Monitoring: A majority of participants monitor four agencies that are part of the U.S. healthcare ecosystem: CMS, AHRQ, FDA and NIH. Most of the LPS monitor two additional agencies: IoM and CDC. A majority of participating companies also monitor four key influencing groups: PCORI, MedPAC, NCQA and NQF.
CMS-FOCUSED FTEs: Study participants dedicate an average of 4 FTEs to monitoring CMS and/or groups that influence CMS; the LPS dedicates an average of 5.7 FTEs to this while Mid-Caps and Emerging firms dedicate about 2.7 FTEs.
Policy Leadership Location: A majority of companies (60%) identified their U.S. HQ as the primary location for Policy. The LPS heavily favor (83%) U.S. HQ as policy’s primary location. The Mid-Cap segment favored Washington D.C. (67%).