Quality systems need to be established and managed in a way that meets requirements and strengthens operations. background: #a1d4ed; .field-ivt-author-photo img, .field-ivt-article-photo img { ① EFFICIENCY. Stability and meeting production targets are no longer enough. .sf-menu.sf-style-default LI OL LI.sf-no-children, .sf-menu.sf-style-default LI UL LI.sf-no-children { border: 1px solid #e82a33; #footer #get-connected H3.title { white-space:nowrap; } } } /* ---- Header / Navigation Menus ---------------------------------------------------------------- */ background: linear-gradient(to right, #bbbfb2 0%,#ffffff 50%,#bbbfb2 100%); By clicking the button below, you confirm that you have read and accept our Privacy Policy. Digital challenges facing the life sciences industry: How Contentful and Coresecure addressed these issues with a mission-critical platform About For companies focused on developing new pharmaceutical therapies, innovation across all aspects of their business is vital to achieve their goal of transforming the lives of people living with medical conditions. #superfish-1 LI A > .sf-sub-indicator { #superfish-1 { /* Primary Site Navigation */ Clinical Analytics | Challenges Facing Pharma and Life Sciences Industry | Quantzig. width: 100%; /* Embedded Images */ border: 0 !important; #page .content .download.compendia A { } .vertical-tabs-nodewords > div:nth-of-type(26), .vertical-tabs-nodewords > div:nth-of-type(27), .vertical-tabs-nodewords > div:nth-of-type(28), #page ARTICLE TABLE TD:not(.gsib_a) { /* ---- Events Related ---------------------------------------------------------------- */ } .field-ivt-author-photo img, .field-ivt-article-photo img { .view-home-page-highlighted.membership H2::before { .cse .gsc-search-button-v2, .gsc-search-button-v2 { .sf-item-5 .sf-megamenu .sf-megamenu-wrapper { .staff IMG { body { white-space: nowrap; letter-spacing: -.005em; line-height: 22px; margin: 1.5em 0 -.25em 0; float: right; margin: 0; But what is needed to obtain this? Being part of a global network gives us access to a pool of specific expertise from around the world, enabling us to address the challenges of multinational pharmaceutical & life sciences organisations. Among the interesting information from the chart is in looking at perceived risk factors that have grown dramatically over the past few years. Panelists, John Lincoln, Valarie King-Bailey and Siegfried Schmitt share their thoughts and predictions on current matters and future possibillities in pharma and medical devices. background: linear-gradient(135deg, #808080 0%, #000 100%); #footer #get-connected { width:250px; } } } font-family: Arial, sans-serif; font-weight: 700; line-height: 20px; #page .content .download { } } background-image: -moz-linear-gradient(top, rgba(255,255,255,0) 0%, rgba(153,153,153,0) 40%, rgba(102,102,102,0) 60%, rgba(0,0,0,0.15) 100%); margin: -10px 0 30px 0; width: 100%; margin: .5em auto; padding: .4em 1.5em .5em 1.5em; text-decoration: none !important; } border-color: #999; .view-home-page-highlighted.membership H2 { h3, h4 { #bundle-pricing, .node-type-article #content .content { } } display: none !important; @import url(http://fonts.googleapis.com/css?family=Open+Sans:800,600); #footer { background: #000; border-top: 4px solid #898989; font-family: Open Sans, sans-serif; } You can continue shopping or proceed to checkout. text-shadow: 0 0 .03125em rgba(232,42,51,.5); } } #sidebar .subscribe, border-bottom: 4px solid #ccc; text-shadow: 0 0 .03125em rgba(0,0,0,.2); #header-inner.container .four.columns { } #edit-ivt-biweekly-newsletters-wrapper, .user-dashboard #add-products-link, #page ARTICLE TD OL, #page ARTICLE TD UL { padding-left: 20px; } font-family: Open Sans, sans-serif; font-size: 18px !important; margin: 1.4em 0; text-align: left; line-height: 18px; letter-spacing: 0; text-align: center; } Implementing change, however, is only half the battle. /* ---- Google CSE (Custom Search Engine) ---------------------------------------------------------------- */ font-family: Arial, sans-serif; background: rgba(255,255,255,.3); border: 1px solid #fff; box-sizing: content-box; color: #6d6e71; text-shadow: 0 0 .03125em rgba(109, 110, 113, .2); .gsc-orderby-container { } .gsc-results { } .gssb_a { font-size: 14px; font-weight: 700; background: #fff; border: 2px solid #e3debc; box-sizing: content-box; Whether driven by market dynamics, company strategy or by short-term targets, management requires greater flexibility in operations. color: #000; text-shadow: 0 0 .03125em rgba(0,0,0,.3); Medtech companies can no longer rely on previous business models to drive growth and should adapt by considering new business models in … } #sidebar .view-cbi-upcoming-conferences ul li, #sidebar .view-ivt-upcoming-conferences ul li { #edit-continue, /* #ivt-user-preferences > fieldset:last-of-type > p:last-of-type > span:first-of-type */ { Modernization, together with the digital transformation, is one of the most significant challenges … display: grid; } #page .content P, #page .content OL, #page .content UL { An agile approach is necessary to meet changes in production (such as product value, power and volumes), implement new technologies, increase delivery precision and reduce time to market. An integrated and flexible approach that brings people, processes and technology together is indispensable for success. Change is almost never a direct path from A to B. Value-oriented change requires a persistent and gradual journey along a winding path. .vertical-tabs-nodewords > div:nth-of-type(44), .vertical-tabs-nodewords > div:nth-of-type(45), .vertical-tabs-nodewords > div:nth-of-type(46), Our Belgium team is part of the PwC global pharmaceuticals and life sciences practice which is made up of over 2,800 dedicated specialists in the pharmaceutical and life sciences industry. color: #808080; border: 0; padding: 1em 0; .field-ivt-author-photo IMG { .ivt-article-highlighted .views-field-title a, .view-journal-article-list .views-field-title span a, .gsc-adBlock, .gcsc-more-maybe-branding-root, .gsc-above-wrapper-area, Web page addresses and e-mail addresses turn into links automatically. .hdr-search #gs_tti50 INPUT[type=text] { #page ARTICLE fieldset.two-column p.pricing-blurb { /* ---- Side Bar ---------------------------------------------------------------- */ #superfish-1 LI A, #superfish-1 LI.first A.sf-depth-1, #superfish-1 LI.last A.sf-depth-1, #superfish-1 LI A.sf-with-ul { margin: .375em auto; padding: .5em 0; position: relative; display: none; } } #header-inner.container .four.columns #cart { background: #fff; border: 0; box-sizing: border-box; font-size: 14px; font-weight: 600; letter-spacing: .005em; background: #cc2c34; color: #fff; text-shadow: 0 0 .03125em rgba(255,255,255,.3); font-size:16px; line-height:20px; display: none; #footer #get-connected #email-us { clear:both; margin-left:5px; padding-top:5px; } h2 { padding-top: .5em; Foley’s Life Sciences Industry Team is composed of corporate, health care, regulatory, and IP attorneys, whose 360º approach helps address your immediate, specific legal issues, while our deep industry knowledge enables us to work with your long-term objectives in mind. height:100px; margin:10px 0 45px 0; width:588px; h1 { .views-field-field-conference-dates-value-1 SPAN.field-content { display: inline-block; font-family: Bitter, Arial, sans-serif; font-size: 24px; font-weight: 700; background: -webkit-linear-gradient(left, #bbbfb2 0%,#ffffff 50%,#bbbfb2 100%); } .page-bundles .search-result-entry > p:first-of-type { } border: 2px solid #fff; border-radius: 100%; content: ""; display: inline-block; Emerging markets are defining themselves in this growth place; however, they have a unique challenge of addressing wide background: -webkit-linear-gradient(-45deg, #808080 0%, #000 100%); Ensuring that change delivers sustainable value is the main business challenge today. .view-home-page-highlighted .views-field-body A:focus IMG, background: #fff url('/sites/default/files/grid-noise.png') repeat; margin-bottom:-13px; min-height:130px; John E. Lincoln, principal consultant, J. E. Lincoln and Associates LLC, assists companies in the design and implementation of complete 21 CFR 111, 210, 211, 820 and ISO 13485 quality management systems, fully CGMP-... Dr. Siegfried Schmitt is Vice President, Regulatory and Access, at PAREXEL Consulting, where he has worked at developing and improving quality management systems; including Quality by Design and Control Strategies since...
Valarie King-Bailey is the CEO of CEO of OnShore Technology Group, an independent Chicago-based consultancy specializing in Independent Validation and Verification (IV&V) products... Best practices to manage the changes in today's tech landscape. } margin: 1.375em 0 2em auto; max-width: 80%; Because of ever-tightening regulatory compliance, the challenge with quality management in life sciences is magnified in comparison to many other industries. This week on Voices in Validation we are pleased to present a panel discussion on Life Science Industry Challenges, Opportunities, and Next Steps. .gsc-control-cse .gs-result .gs-title b, .gs-webResult div.gs-visibleUrl b, fieldset.two-column p.pricing-blurb { margin-left: 5px; margin-right: 5px; } margin: 0 !important; padding-top: 10px; border-color: #6d6e71; } grid-template-rows: min-content; These include target selection, drug discovery, clinical development, manufacturing, and supply chain planning. #ivt-user-non-member-newsletter-full-form #edit-ivt-biweekly-newsletter-wrapper { display: none !important; } content: " the Conference Compendium"; Blog posts from SoftExpert about Automotive Industry. .form-button-wrapper .link-button { } } color: #000; text-shadow: 0 0 .03125em rgba(0,0,0,.5); When it comes to marketing, the life science industry has always lagged a bit behind as compared to other verticals. } font-size: inherit; font-style: normal; font-weight: 400; color: #6d6e71; text-shadow: 0 0 .03125em rgba(109, 110, 113, .8); The basis of the microbiologist to develop strategy. .staff { margin-top: 1em !important; line-height: 1.375; margin: 1em 0 1.375em 0; #page .content blockquote P:nth-of-type(2) STRONG { font-style: normal; } font-family: Open Sans, Arial, sans-serif; #sidebar .view-content .views-field-title a:hover, p, .field-content, ol, ul { } h2, h3, h4, h5, h6 { } .user-dashboard #add-products-link { In the face of increasing global competition, there are four overriding challenges facing the Life Science industry today. .node-type-article #content ARTICLE HEADER { #page .content blockquote P:nth-of-type(2)::before { content: '–'; margin-right: .125em; } } border: 1px dashed #6d6e71; margin: 2em; padding: 1.25em 1em; It is a complex environment where patient safety is paramount. Success requires an integrated and pragmatic approach to risk management that strengthens operations and optimizes resource use. padding-bottom: 0; #page ARTICLE .content > DIV > P > IMG.embed, /* Buttons */ #page .content .download A { grid-template-columns: auto 300px; Medtech companies can no longer rely on previous business models to drive growth and should adapt by considering new business models in … background: -moz-linear-gradient(-45deg, rgba(232,42,51,0.1) 0%, rgba(232,42,51,0) 100%); } that is most relevant to you. /* custom FREE pdf */ The pharma and life sciences industry is facing unprecedented challenges across all aspects of their organizations. .menugrid A:active, .menugrid A:focus, .menugrid A:hover { background: rgb(0,0,0); background: #f26974; } } font-size: 20px; } /* ---- Products ---------------------------------------------------------------- */ max-width: 100%; } #sidebar .subscribe { #footer .advanstar-logo #advanstar-logo { /* Authors */ SoftExpert is a market leader in software for enterprise-wide business processes automation and improvement, compliance management and corporate governance, with more than 300,000 users from 2,000 organizations, operating in over 30 countries worldwide. .ivt-article-highlighted .views-field-field-gallery-photos-fid img, .ivt-article-highlighted .views-field-field-video-video-video-id img, #superfish-1 > LI { When it comes to technology in the Life Science sector today, many companies are investing in Enterprise Quality Management (EQM) software to enhance visibility and collaboration between functional areas that affect the product. } } Scientific laboratories and offices are a big revenue opportunity in the region, most panelists and attendees agreed at the Life Sciences 2018 … .vertical-tabs-nodewords > div:nth-of-type(20), .vertical-tabs-nodewords > div:nth-of-type(21), .vertical-tabs-nodewords > div:nth-of-type(22), display: grid; /* ---- Footer ---------------------------------------------------------------- */ Cohesive integration and clear communication across different company sectors make a big difference in the final result. font-size: 18px; /* ---- Signup Pages ---------------------------------------------------------------- */ background: #f2f4f5; border: 2px solid transparent; box-sizing: border-box; Brexit Bring Uncertainty. display: none !important; h3.comments { background: #E82A33; border-radius: 3px; a, a:active, a:hover, a:link, a:visited { } background: -webkit-linear-gradient(bottom, #f26974 0%,#cc2c34 100%); } #sidebar .views-field-field-conference-register-url-url A, #sidebar .views-field-field-conference-brochure-url-url A { } .vertical-tabs-nodewords > div:nth-of-type(40), .vertical-tabs-nodewords > div:nth-of-type(41), .vertical-tabs-nodewords > div:nth-of-type(42), color: #fff !important; text-shadow: 0 0 .03125em rgba(255,255,255,.3) !important; Behind these two driving forces is the complex world of the medication or medical device life cycle. } border: 2px solid #e3edbc; float: left; #content { By helping these providers meet tomorrow’s issues, you can ensure your own success today. text-align: center !important; width: auto !important; A number of drivers will continue to transform life sciences in 2020, with pharmaceutical companies, medtech organizations, and other stakeholders looking to create new value while tackling challenges in such areas as interoperability, patient experience, and the continued arrival of outside organizations into the health care space. border: 1px solid #fff; margin: .5em 0; padding: 1.25em .5em; filter: progid:DXImageTransform.Microsoft.gradient( startColorstr='#e8cc89', endColorstr='#e8cc89',GradientType=1 ); } .page-bundles .search-result-entry:nth-child(odd) { background: #f5f7f0; } letter-spacing: 0; margin: 1em 0; text-align: left; #header-inner.container .five.columns { } display: inline-block; margin: 5px 10px 5px 0; padding: 1px 1em 3px 1em; text-decoration: none !important; Organizations are under increasing pressure to simultaneously increase productivity and reduce waste. background: -webkit-linear-gradient(-45deg, #e8cc89 0%,#ffffff 50%,#e8cc89 100%); .sf-item-3 .sf-megamenu .sf-megamenu-wrapper { width:auto; } .cta:active, .cta:focus, .cta:hover { Addressing the business challenges of the Life Sciences Industry The transformation required by Life Sciences companies includes core shifts in business processes, strategic planning, regulatory frameworks, as well as technological solutions. } #sidebar .content P { margin:1em 10px; } display: none; .ivt-article-list .views-field-nothing, .ivt-article-list .views-field-nothing-1 { float: left; max-width: 397px; min-height: 160px; padding: 1em; .front h1.title { display: none; } .view-home-page-highlighted P, .view-home-page-highlighted .views-field-body P { letter-spacing: .01em; line-height: 1.125; margin: 2em 0 .75em 0;