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ISPOR - Real-World Data and Real-World Evidence in Support of Drug Development: Will China Soon be Leading the Way?

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0-1.277-.267-1.16-1.067h.464v-.067z"></path></g> </g> </g> </g> </svg></a></div> </div> </div> <div id="top-utility" class="flex-center"> <div id="Header_TBB0D3FF1011_Col01" class="sf_colsIn" data-sf-element="Top Utility" data-placeholder-label="Top Utility"> <div > <div class="sfContentBlock sf-Long-text" ><a class="button back" href="/conferences/upcoming-conferences/ispor-asia-pacific-2022">ISPOR Asia Pacific 2022 Home</a></div> </div> </div> <div class="js-element is-hidden mg-site-search"> <button type="button" class="search__close"> <span class="glyphicon glyphicon-remove"></span> </button> <input name="q" type="text" class="input search-input" placeholder="enter keyword"> </div> <button type="button" class="button toggle-search toggle-search--show"> <span class="glyphicon glyphicon-search is-size-4"> </span> </button> <button type="button" class="button toggle-search toggle-search--hide"> <span class="glyphicon glyphicon-search is-size-4"> </span> </button> <div 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section" data-sf-element="Row"> <div id="Main_T8B58AE33005_Col00" class="sf_colsIn section container" data-sf-element="Column 1" data-placeholder-label="Column 1"><div class="row" data-sf-element="Row"> <div id="Main_T53118E99023_Col00" class="sf_colsIn col-md-12" data-sf-element="Column 1" data-placeholder-label="Column 1"><div> <ul class="sf-breadscrumb breadcrumb"> <li><a href="/">Home </a></li> <li><a href="/conferences-education">Events </a></li> <li><a href="/conferences-education/conferences/past-conferences">Past Conferences </a></li> <li><a href="/conferences-education/conferences/past-conferences/ispor-asia-pacific-2022">ISPOR Asia Pacific 2022 </a></li> <li><a href="/conferences-education/conferences/past-conferences/ispor-asia-pacific-2022/program">Program </a></li> <li><a href="/conferences-education/conferences/past-conferences/ispor-asia-pacific-2022/program/program">Virtual Program </a></li> <li class="active">Session</li> </ul> </div><div class="row" data-sf-element="Row"> <div id="Main_C027_Col00" class="sf_colsIn col-md-8" data-sf-element="Column 1" data-placeholder-label="Column 1"> <div > <div class="sfContentBlock sf-Long-text" ><br /><h1>Virtual Program</h1></div> </div> </div> <div id="Main_C027_Col01" class="sf_colsIn col-md-4" data-sf-element="Column 2" data-placeholder-label="Column 2"> </div> </div> <div class="row" data-sf-element="Row"> <div id="Main_C021_Col00" class="sf_colsIn col-md-12" data-sf-element="Column 1" data-placeholder-label="Column 1"> <div > <div class="sfContentBlock sf-Long-text" ><p>Our 2-day virtual summit, to be held 20-21 September, features thought-provoking plenary sessions, topical presentations and discussions, educational symposia and speakers from a diverse array of backgrounds excited to share with you a wealth of ideas, experiences, and perspectives on the latest HEOR topics in Asia Pacific.&nbsp;</p><p>Special Bonus: Registration includes extended access to all session playback recordings through 21 October 2022.</p><p>Note: Times shown within the program are in Korean Standard Time (KST).&nbsp;The Summit will be presented in English without translation.</p></div> </div> </div> </div> <div class="confex-session-detail" > <h1 class="session-title">Real-World Data and Real-World Evidence in Support of Drug Development: Will China Soon be Leading the Way?</h1> <div class="session-section"> <h2>Speaker(s)</h2> <p class="m-0"><b>Moderator: </b>Amanda Pulfer, BA (Hons), Evidera, London, UK <br><b>Panelists: </b>Lu Ban, PhD, Evidera, Beijing, China; Haijun Cao, MD, PhD, Happy Life Technology, Shanghai, China; Sunil Garg, PhD, Astellas Pharma Singapore Pte. Ltd, SINGAPORE, 01, Singapore</p> </div> <div class="session-section"> <h2>Presentation Documents</h2> <ul class="list-separated"> <li><a href="https://www.ispor.org/docs/default-source/asia2022/ispor-asia-sunilg-astellas21-sep-2022.pdf?sfvrsn=3a23c78e_0">ISPOR Asia _SunilG Astellas_21 Sep 2022</a></li> <li><a href="https://www.ispor.org/docs/default-source/asia2022/ispor-asia-pacific-summit-presentationhaijun-cao.pdf?sfvrsn=589037e_0">ISPOR Asia Pacific Summit Presentation_Haijun Cao</a></li> <li><a href="https://www.ispor.org/docs/default-source/asia2022/ap22bangargcao-with-speakers.pdf?sfvrsn=1bcf4e6e_0">AP22_Ban_Garg_Cao with Speakers</a></li> </ul> </div> <div class="session-section session-abstract"> <div><p><b>ISSUE: </b>Similar to the US, China is exploring use of RWE in support of drug development and regulatory decisions. In parallel the data landscape is fast evolving with emerging local RWD sources providing rich data. This session focuses on recent developments in utilising RWE across the product lifecycle and potential challenges and opportunities of China RWD sources. Stakeholders from different organizations will share their perspective and experiences. Dr Lu Ban (Evidera) will provide an up-to-date overview of the regulatory context and the need for RWE generation (15 minutes). Dr Haijun Cao (HLT) will discuss opportunities and challenges of RWD in China and guidance for study success (15 minutes). Dr Sunil Garg (Astellas) will provide an industry perspective on the need and challenges in generating RWE in China and potential mitigation strategies (15 minutes).</p> <p><b>OVERVIEW: </b>RWE plays an increasingly significant role in life-cycle management of therapeutic interventions including regulatory and pricing and reimbursement decision making. The Centre for Drug Evaluation (CDE) encourages exploration of RWE to provide supporting evidence for label expansion and effectiveness and safety of products post launch in China. In addition, real-world studies are being undertaken to describe incidence and prevalence of disease, treatment pathway, healthcare resource utilization and clinical and economic burden. RWE is also used to inform payers on National Reimbursement Drug List (NRDL) listing, budget impact analysis, or new round negotiations to limit price cuts in NRDL. In parallel RWE research opportunities are driven by the expanding data landscape. However appropriate data collection, curation, standardization, and validation are required. Advanced analytic techniques including machine learning and AI technology play a crucial role in managing large unstructured data sets. Executing RWE studies requires understanding of unique study approval landscape in China <span>for efficiently delivery of RWE generation programs.</span></div> </div> <div class="session-section"> <h2>Code</h2> <p class="mt-0">IP16</p> </div> </div> </div> </div> </div> </div> <div > <div class="sfContentBlock sf-Long-text" ></div> </div> </main> <!--stopindex--> <footer class="section__footer py-8"> <div id="footer__links" class="container"> <div class="row"> <div class="col-md-5"> <div > <div class="sfContentBlock sf-Long-text" ><h5>Quick Links</h5><hr /></div> </div> <div> <ul class="footer-nav"> <li class=""> <a href="/about" target="_self">About</a> </li> <li class=""> <a href="/heor-resources/news-top/news/media-center" target="_self">Media Center</a> </li> <li class=""> <a href="/conferences-education/conferences/exhibits-sponsorships" target="_self">Exhibits &amp; Sponsorships</a> </li> <li class=""> <a href="/about/contact-us" target="_self">Contact Us</a> </li> </ul> </div> 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