World Monitor Magazine April 2017 - Page 117

additional content the U.S. demand multiple submissions of drug approval applications to satisfy the rules in every region, and extensive documentation to meet clinical trial and pharmacovigilance standards. At the same time, regulators are taking steps to accelerate innovation and efficiently license medicines, diagnostics, and digital applications that demonstrate positive outcomes. By communicating with regulators proactively, pharma companies now have the opportunity to grant patients early access to new medications, particularly those that target unmet diagnostic and treatment needs. At the same time, regulators — as well as providers and payors — appreciate fast-cycle analytics on patient progress to support value-based healthcare solutions. By communicating with regulators proactively, pharma companies have the opportunity to grant patients early access to new medications. cohort of individuals and how to achieve the best patient outcomes. • Squeeze on healthcare budgets. Public and private payors are relying more on patient outcomes to make decisions that are aimed at managing scarce budgets and focusing on cost-effectiveness and comparative clinical effectiveness. • Rise of health technologies. Advances in mobile communications and the digitization of health diagnostics, treatment, equipment, and services are changing how care is delivered and how pharmaceutical companies conduct R&D. As new technologies emerge, new regulatory policies follow, adding complexity to the approval and reimbursement processes. • Empowered consumerism. Consumers are playing a more critical r H[]\YܙH[Z\ۈ\K[X[[[[YX\[ܛX][ۈ[][Z\ۙ][ۜ[X]Y[ܘ[\ˈH[H\[Y[[œ^[ܜY[]ܜ[X[XZ\˂\XX]]X[\[Y\\BYXY[HYH[Hق\X\ΈX[H\\وY^H][ ]\ۈ\X\[\Y[ [HH^H]\^H[]Y[\X[KH\ڛ[Y\[B\XX]]X[\[Y\\[Bܛۙ۝X[X[Y[]ܞBۜZ[ˈ[ܙX\[H\^[XY[]ܞHXY\[]\H[[ZY\۝^ ]Y[\H^Z[˜HY\H[HX[\H[[ZX[]\YܙK^H[ܙX\[B[H\\[]\Z[[Z\X[\H]YY\[Y\[HX\[[]ݚY\š[XZ[[ܛYYX\[ۜ˂[YX\[ۜ\H\[[ۂX\[[Y[H[[ۜ][ۜ›وY]Y\[YXXHB\XX]]X[\[Y\ˈ ܈B\^HوH^\[\\\]\XX]]X[\[Y\XKYB^X] KB[\]HHY[]ܞHX^B]\XX]]X[\[Y\›]\]Y]K]YI&\œ]YHۜ[[\[\[[^Y^[܈X\[ۜ[]Y NHY˜\ݙYHH]\X[YYX[\Y[H[HKˈ[Yœ\ܝYHUTАRŒLL