[WORKING GROUPS] Mail FeedConfluence Syndication Feedhttps://advance.phuse.globalDigital Health Technologies (DHTs)Kerry Robsontag:advance.phuse.global,2009:page-11862071-822024-03-28T16:07:32Z2021-06-23T07:55:24Z<div class="feed"> <p>
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<div class="table-wrap"><table class="wrapped relative-table confluenceTable" style="width: 99.5789%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey" title="Background colour : "><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The project will introduce and identify the current state of topics relating to the usage of digital health technologies in clinical trials and regulatory submissions:</span></p><ul><li><span style="color: rgb(51,51,51);">The use of DHT in the clinical space</span></li><li><span style="color: rgb(51,51,51);">Continuous data flow from telemedicine and telehealth platforms, mobile health (mHealth), wearable/implantable devices, software as a medical device (SaMD)</span></li><li><span style="color: rgb(51,51,51);">Clinical and analytical validation of medical devices</span></li><li><span style="color: rgb(51,51,51);">Digital biomarkers, digital interventions and digital medicine</span></li></ul><p><span style="color: rgb(51,51,51);">The project will also provide a common platform to discuss regulatory guidance around DHT.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.7437%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th scope="col" class="confluenceTh"><span style="color: rgb(51,51,51);">Problem Statement </span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Digital biomarkers cannot be explained without providing context to the larger eco-system of digital health technology (DHT). Digital health technology has been growing rapidly in recent years, and this trend is expected to continue. The COVID-19 pandemic has also accelerated the adoption of digital health technologies as people have become more accustomed to receiving healthcare services remotely.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.7437%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh">Problem Impact </th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">We are requesting to change the Digital Biomarker Working Group project with Digital Health Technology. Navigating the regulatory landscape for digital health technologies can be challenging. Companies need to be proactive in understanding the regulatory requirements that apply to their products and work closely with regulators to ensure they are meeting these requirements in a timely and efficient manner.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.0399%;"><colgroup><col style="width: 45.6603%;"/><col style="width: 54.3247%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);"><strong>Project Leads</strong></span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);"><strong>Email</strong></span></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Vijay Pasapula, <em>Cerus</em></span></td><td class="confluenceTd"><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:VPasapula@cerus.com" rel="nofollow" style="color: rgb(51,102,255);">VPasapula@cerus.com</a></span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Unnat Patel, <em>AnalysisMate</em></span></td><td class="confluenceTd"><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:unnat.patel@analysismate.com" rel="nofollow" style="color: rgb(51,102,255);">unnat.patel@analysismate.com</a></span></td></tr><tr><td style="text-align: left;" class="confluenceTd"><span style="color: rgb(51,51,51);">Kerry Robson, <em>PHUSE Project Assistant</em></span></td><td style="text-align: left;" class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="wrapped relative-table confluenceTable" style="width: 99.3722%;"><colgroup><col style="width: 100.026%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><p>White paper on digital health technologies</p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.2614%;"><colgroup class=""><col class="" style="width: 45.6978%;"/><col class="" style="width: 54.3022%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Timelines</span></th></tr><tr class=""><td class="confluenceTd">Produce a poster / paper for US Connect</td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Q1 2024 </span></p></td></tr><tr class=""><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Produce a White Paper</span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Q3 2024 </span></p></td></tr><tr class=""><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Deliver a presentation at a PHUSE Single Day Event on DHTs</span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Q3 2023</span></p></td></tr></tbody></table></div></div>
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</div>Kerry Robson2021-06-23T07:55:24ZCloud Adoption in the Life Sciences IndustryKerry Robsontag:advance.phuse.global,2009:page-327838-1112024-03-28T16:07:09Z2020-10-28T14:04:23Z<div class="feed"> <p>
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<div class="table-wrap"><table class="wrapped confluenceTable"><colgroup><col/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey" title="Background colour : "><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="letter-spacing: 0.0px;color: rgb(51,51,51);">Cloud technology and its use of multi-tennant app solutions are increasing the capabilities of Life Sciences solutions and reducing IT infrastructure costs through the sharing of infrastructure and investment cross-industry.</span></p><p><span style="color: rgb(51,51,51);">In some areas multi-tenant cloud solutions have become ubiquitous. For example, <a class="external-link" href="http://Salesforce.com" rel="nofollow" style="color: rgb(51,51,51);">Salesforce.com</a> claim >150K customers utilize their platform for Customer Relationship Management. Furthermore, many routinely rely on Cloud services associated with their computer backups and data services associated with cell phones.</span></p><p><span style="color: rgb(51,51,51);">Nonetheless, the perceptions and interpretations of the regulations by which the Life Sciences industry must conduct its business still leave many uncertain about whether or not they can (or should) pursue the use of Cloud solutions for GxP applications.</span></p><p><span style="color: rgb(51,51,51);">The goal of this project has been to provide a practical, usable framework to overcome those barriers. Through the use of this framework, it is envisaged that the barriers to adoption by Pharma of Cloud-based technology will be addressed.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.483%;"><colgroup><col style="width: 49.975%;"/><col style="width: 49.975%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Email</span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Anders Vidstrup, <em>NNIT</em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:anders@vidstrup.dk" rel="nofollow" style="text-decoration: underline;color: rgb(51,102,255);">anders@vidstrup.dk</a></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Kerry Robson, <em>PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.483%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024 </span></p></div></th></tr><tr><td class="confluenceTd"><p>This quarter, the definition of the term exit strategy must be in place including the main structure of the document. Sub-chapters to be assigned to group members</p></td></tr></tbody></table></div><div class="table-wrap"><table class="wrapped confluenceTable"><tbody><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The team has representatives from SaaS, PaaS and IaaS providers, as well as 'consumer organisations' Stakeholders. This project has generated value for several levels of stakeholders.</span></p><ul><li class="auto-cursor-target"><p><span style="color: rgb(51,51,51);">For the wider audience interested in knowing what is possible in Cloud computing, it has generated use cases that illustrate the successful implementations, or pitfalls, in the use of Cloud-based technology.</span></p></li><li class="auto-cursor-target"><p><span style="color: rgb(51,51,51);">For IT professionals it has generated information materials that help to guide efforts to implement quickly, and in regulatory compliance, Cloud technologies as well as providing decision trees to support technology decision making.</span></p></li><li class="auto-cursor-target"><p><span style="color: rgb(51,51,51);">For the regulatory professionals, it provides a clear mapping between technology capabilities and regulatory requirements.</span></p></li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.483%;"><colgroup><col style="width: 50.5248%;"/><col style="width: 49.4903%;"/></colgroup><tbody><tr><th class="confluenceTh"><h4 id="CloudAdoptionintheLifeSciencesIndustry-Objectives&Deliverables"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></h4></th><th class="confluenceTh"><h4 id="CloudAdoptionintheLifeSciencesIndustry-Timelines"><span style="color: rgb(51,51,51);">Timelines</span></h4></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Updated main document - Preamble </span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q3 2022</span></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.483%;"><colgroup><col style="width: 62.5512%;"/><col style="width: 37.4546%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" colspan="2" data-highlight-colour="grey"><span style="color: rgb(51,51,51);"><strong title="">Published Deliverables</strong></span></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Emerging+Trends+%26+Technologies/WP072.pdf" rel="nofollow" style="color: rgb(51,102,255);">Cloud Framework – Audit Activities</a></span></p></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">1-Jul-2022</span></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Emerging+Trends+%26+Technologies/Cloud+Adoption+Framework+Documents+Version+4.0.zip" rel="nofollow" style="color: rgb(51,102,255);">Cloud Adoption – Framework Documents: Version 4.0</a></span></p><ul><li><p><span style="color: rgb(51,51,51);">To include, Preamble, Audit Activities, Regulatory Requirements, Terminology.</span></p></li></ul></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">24-Apr-2019</span></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Emerging+Trends+%26+Technologies/Cloud+Framework+Pre-Amble.pdf" rel="nofollow" style="text-align: left;color: rgb(51,102,255);">Cloud Framework, Pre-Amble</a></span></p></td><td class="confluenceTd">27-Nov-2023</td></tr></tbody></table></div></div>
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</div>Kerry Robson2020-10-28T14:04:23ZAI/ML in Digital Health Technologies (DHTs)Kerry Robsontag:advance.phuse.global,2009:page-75399198-352024-03-28T16:06:44Z2023-06-07T13:31:48Z<div class="feed"> <p>
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<h4 id="AI/MLinDigitalHealthTechnologies(DHTs)-https://advance.phuse.global/x/bgAF"><a href="https://advance.phuse.global/x/bgAF" rel="nofollow"><span class="confluence-embedded-file-wrapper image-left-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image image-left" draggable="false" width="1050" src="https://advance.phuse.global/download/attachments/75399198/ETT%20web.jpg?version=1&modificationDate=1686144740814&api=v2" data-image-src="https://advance.phuse.global/download/attachments/75399198/ETT%20web.jpg?version=1&modificationDate=1686144740814&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="75399199" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="ETT web.jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="75399198" data-linked-resource-container-version="35" alt=""></span></a></h4></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.018%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><strong><span>Project Scope </span></strong></p></td></tr><tr><td class="confluenceTd"><p>The use cases of artificial intelligence and machine learning (AI/ML) in digital health technologies to improve healthcare through software. Understand the challenges, and identify the gaps. Connect different stakeholders, share knowledge, and advance in developing AI/ML in DHTs. </p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.908%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh">Project Statement </th></tr><tr><td class="confluenceTd"><p>DHTs are revolutionising the healthcare industry, with AI/ML playing a key role in the development of new solutions. With more applications of AI/ML in practice, from optimising workflows to improving diagnostic capabilities, the collaborations to learn from the use cases and the partnership to overcome challenges are urgently needed.</p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.7425%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh">Project Impact </th></tr><tr><td class="confluenceTd"><p><span style="color: black;text-decoration: none;">The integrated effort to study real-world applications will ensure the emerging technologies are used effectively and in compliance </span><span style="color: rgb(0,0,0);text-decoration: none;">with relevant guidelines and regulations.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 108.055%;"><colgroup><col style="width: 42.3967%;"/><col style="width: 57.6033%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Email</span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Ying Su, <em>Pfizer</em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:ying.su2@pfizer.com" rel="nofollow" style="color: rgb(51,102,255);">ying.su2@pfizer.com</a></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Radha Railkar, <em>Merck</em></span></p></td><td class="confluenceTd"><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:radha_railkar@merck.com" rel="nofollow" style="color: rgb(51,102,255);">radha_railkar@merck.com</a></span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Kerry Robson, <em>PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.7977%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><ul><li><p>Sub-teams had kick-off meetings</p></li><li><p><span style="letter-spacing: 0.0px;">Started rolling out communication and activities (planning and outreach)</span></p></li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.7977%;"><colgroup><col style="width: 51.2612%;"/><col style="width: 48.7098%;"/></colgroup><tbody><tr><th class="confluenceTh"><h4 id="AI/MLinDigitalHealthTechnologies(DHTs)-Objectives&Deliverables"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></h4></th><th class="confluenceTh"><h4 id="AI/MLinDigitalHealthTechnologies(DHTs)-Timelines"><span style="color: rgb(51,51,51);">Timelines</span></h4></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Identify the industry knowledge-sharing community of practice, prioritise future project topics</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q2/3 2023</span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">PHUSE/FDA CSS presentation/poster</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q3 2023</span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Start gathering use cases </span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q4 2023</span></td></tr><tr><td rowspan="2" class="confluenceTd"><p><span style="color: rgb(51,51,51);">Quarterly Community Forums</span></p><p><span style="color: rgb(51,51,51);">Invited expert talks </span><span style="color: rgb(51,51,51);"><br/></span></p></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q1 2024</span></td></tr><tr><td class="confluenceTd">Q2 2025</td></tr></tbody></table></div></div>
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<p><br/></p><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.2857%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th scope="col" class="confluenceTh"><h4 id="AI/MLinDigitalHealthTechnologies(DHTs)-AI/MLSub-teams"><span style="color: rgb(0,0,0);text-decoration: none;">AI/ML Sub-teams</span></h4></th></tr><tr><td class="confluenceTd"><span style="color: rgb(0,0,0);text-decoration: none;">The project volunteers are organised in sub-teams to learn a specific topic through planning/facilitating a forum with experts, and collecting use cases. Please indicate your participation by filling out the <a class="external-link" href="https://forms.office.com/e/4xbmNVuAai" rel="nofollow">form</a> to join the sub-team of your interest</span></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.4505%;"><colgroup><col style="width: 7.24154%;"/><col style="width: 79.3809%;"/><col style="width: 13.3775%;"/></colgroup><tbody><tr><td class="confluenceTd"><p class="p1"><strong>Sub-Team</strong></p></td><td class="confluenceTd"><p class="p1"><strong>Forum Topic</strong></p></td><td class="confluenceTd"><p class="p1"><strong>Lead</strong></p></td></tr><tr><td style="text-align: center;" class="confluenceTd"><p class="p2"><strong>GA</strong></p></td><td class="confluenceTd"><p class="p1">Generative AI in healthcare</p></td><td class="confluenceTd"><p class="p1">Jeffrey Lavenberg</p></td></tr><tr><td style="text-align: center;" class="confluenceTd"><p class="p2"><strong>AP</strong></p></td><td class="confluenceTd"><p class="p1">Application of AI/ML in precision medicine (includes RWE)</p></td><td class="confluenceTd"><p class="p1">Shraddha Thakkar</p></td></tr><tr><td style="text-align: center;" class="confluenceTd"><p class="p2"><strong>RL</strong></p></td><td class="confluenceTd"><p class="p1">Regulatory landscape of AI/ML in DHTs (current landscape, knowledge gaps, best practices for regulatory submissions, challenges of regulating AI)</p></td><td class="confluenceTd"><p class="p1">Richard Baumgartner</p></td></tr><tr><td style="text-align: center;" class="confluenceTd"><p class="p2"><strong>MD</strong></p></td><td class="confluenceTd"><p class="p1">AI/ML models (logistic regression, support vector machines, decision tree, convolutional neural networks, etc.)</p></td><td class="confluenceTd"><p class="p1">Hanming Tu</p></td></tr><tr><td style="text-align: center;" class="confluenceTd"><p class="p2"><strong>UC</strong></p></td><td class="confluenceTd"><p class="p1">Challenges of use of AI/ML in DHTs (ethical concerns, privacy issues/cybersecurity, misuse of data, complexity of data management including data interoperability, etc.)</p></td><td class="confluenceTd"><p class="p1">Jessica Hu</p></td></tr><tr><td style="text-align: center;" class="confluenceTd"><p class="p2"><strong>SD</strong></p></td><td class="confluenceTd"><p class="p1">Software-driven medical devices</p></td><td class="confluenceTd"><p class="p1">Anders Vidstrup</p></td></tr></tbody></table></div></div>
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</div>Kerry Robson2023-06-07T13:31:48ZPharmaDevOps: Development Operations Guidance for Clinical Reporting CodebasesKerry Robsontag:advance.phuse.global,2009:page-75399294-242024-03-28T16:05:12Z2023-06-19T13:32:18Z<div class="feed"> <p>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 1524.0px;"><colgroup><col style="width: 1523.0px;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey" style="text-align: left;"><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope </strong></span></p></td></tr><tr><td style="text-align: left;" class="confluenceTd"><ul><li><span style="color: rgb(51,51,51);">Landscape of what CICD is used today across the pharmaverse, and key pre-named reference packages outside the pharmaverse used in clinical reporting (e.g. ggplot2, survminer).</span></li><li><span style="color: rgb(51,51,51);">Summarise integration deployment and release pain points within these R packages.</span></li><li><span style="color: rgb(51,51,51);">Connect with the R Validation Hub and vendor tooling (e.g. Atorus openvalidate) to understand what key devops tooling could be applied to packages to accelerate validation.</span></li><li><span style="color: rgb(51,51,51);"><strong>Deliverable 1:</strong> Summarise the state of DevOps in the pharmaverse today, with proposals on key tools used already, and where there are gaps.</span></li><li><span style="color: rgb(51,51,51);"><strong>Deliverable 2:</strong> Develop the existing CICD library used in some pharmaverse R packages (referenced earlier in this proposal) to:</span><ul><li><span style="color: rgb(51,51,51);">deliver a recommended suite of CICD tools for R and python packages that improve developer efficiency, and ensure code is well tested and consistent when merged to branch</span></li><li><span style="color: rgb(51,51,51);">provide off-the-shelf configurations to use tools such as docker images managed locally or via Github codespaces to simplify environment management.</span></li></ul></li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 46.6653%;"/><col style="width: 53.3591%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Email </span></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Dinakar Kulkarni, <em>Genentech</em></span></td><td class="confluenceTd"><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:kulkard2@gene.com" rel="nofollow" style="color: rgb(51,102,255);">kulkard2@gene.com</a><span style="text-decoration: none;"> </span></span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">James Black, <em>Roche</em></span></td><td class="confluenceTd"><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:James.black.jb2@roche.com" rel="nofollow" style="color: rgb(51,102,255);">James.black.jb2@roche.com</a></span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Ben Straub, <em>GSK</em></span></td><td class="confluenceTd"><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:ben.x.straub@gsk.com" rel="nofollow" style="color: rgb(51,102,255);">ben.x.straub@gsk.com</a></span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Kerry Robson, <em>PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 46.4345%;"/><col style="width: 53.5898%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" colspan="2" data-highlight-colour="grey"><div class="content-wrapper" title=""><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> <strong>Q1 2024</strong></span></p></div></td></tr><tr><td colspan="2" class="confluenceTd"><ul><li>Hit 1.0 target on <a class="external-link" href="https://phuse-org.github.io/devops/" rel="nofollow">GitHub</a></li><li>v0.9 was presented at the PHUSE US Connect as an oral presentation</li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup class=""><col class="" style="width: 46.7508%;"/><col class="" style="width: 53.2735%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Timelines </span></th></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Preparation of deliverable for PHUSE US Connect 2024</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q3 2023</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">V1.0 of suite/library of CICD tools released</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q4 2023</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Support adoption across pharmaverse and biostatistics packages where maintainers are willing to collaborate</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q1 2024 </span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Close V1.0 with hackathon in the lead-up to the PHUSE CSS 2024</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q2/Q3 2024</span></td></tr></tbody></table></div></div>
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</div>Kerry Robson2023-06-19T13:32:18ZDemonstrating Real-World Impact of Modernization of Statistical Analytics (MSA) FrameworkKerry Robsontag:advance.phuse.global,2009:page-96665888-92024-03-28T16:04:38Z2024-02-20T18:16:30Z<div class="feed"> <p>
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<p><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="195" src="https://advance.phuse.global/download/attachments/327886/%2323407%20PHUSE%20Working%20Group%20Banners%20Aug%202020%20Web%20Size%20v3_Data%20Visualisation.jpg?version=1&modificationDate=1604049815337&api=v2" data-image-src="https://advance.phuse.global/download/attachments/327886/%2323407%20PHUSE%20Working%20Group%20Banners%20Aug%202020%20Web%20Size%20v3_Data%20Visualisation.jpg?version=1&modificationDate=1604049815337&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="327962" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="#23407 PHUSE Working Group Banners Aug 2020 Web Size v3_Data Visualisation.jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="327886" data-linked-resource-container-version="52" alt=""></span></p></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.1586%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Scope</span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The PHUSE project team will extend the MSA framework by creating a reference architecture that takes into account real-world scenarios and design solutions to remediate them, ultimately providing a practical guide to building an end-to-end validated environment for regulated work. <span style="letter-spacing: 0.0px;">Companies seeking to build an open-source programming environment for regulatory reporting can leverage the MSA framework for guidance. However, since the framework is designed to be both flexible and extensible, implementing it may prove challenging for companies, resulting in situations where risks are not sufficiently mitigated. While the original MSA paper provided conceptual guidance, the PHUSE handover of the project will seek to provide an overview of practical implementations of the framework being applied.</span></span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="wrapped relative-table confluenceTable" style="width: 98.1425%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th scope="col" class="confluenceTh"><span style="color: rgb(51,51,51);">Problem Statement</span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The TransCelerate MSA framework published in 2021 has completed its mission to develop a framework for building an open-source software computing environment for clinical analysis and reporting. Since TransCelerate does not sponsor building of solutions, demonstrating the use and benefit of the MSA framework with specific tools and concrete implementation steps could not be realised. A PHUSE handover of the project grants the opportunity to look at real-world solutions and implementations.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.0399%;"><colgroup><col style="width: 58.343%;"/><col style="width: 41.6605%;"/></colgroup><tbody><tr><th class="confluenceTh"><p><span style="color: rgb(51,51,51);">Project Leads</span></p></th><th class="confluenceTh"><p>Email</p></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);text-decoration: none;">Benjamin Chiang, <em>Sanofi</em></span></td><td class="confluenceTd"><a class="external-link" href="mailto:benjamin.chiang@sanofi.com" rel="nofollow">benjamin.chiang@sanofi.com</a></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Kerry Robson, <em>PHUSE Project Assistant</em></span></p></td><td class="confluenceTd"><p><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.1404%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th scope="col" class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd">New project proposal approved</td></tr></tbody></table></div></div>
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</div>Kerry Robson2024-02-20T18:16:30ZComparing Analysis Method Implementations in Software (CAMIS)Kerry Robsontag:advance.phuse.global,2009:page-327874-902024-03-28T16:04:12Z2020-10-29T09:33:45Z<div class="feed"> <p>
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<p><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" width="1050" src="https://advance.phuse.global/download/attachments/327874/%2323407%20PHUSE%20Working%20Group%20Banners%20Aug%202020%20Web%20Size%20v3_Data%20Visualisation.jpg?version=1&modificationDate=1604049612749&api=v2" data-image-src="https://advance.phuse.global/download/attachments/327874/%2323407%20PHUSE%20Working%20Group%20Banners%20Aug%202020%20Web%20Size%20v3_Data%20Visualisation.jpg?version=1&modificationDate=1604049612749&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="327950" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="#23407 PHUSE Working Group Banners Aug 2020 Web Size v3_Data Visualisation.jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="327874" data-linked-resource-container-version="90" alt=""></span></p><p><br/></p></div>
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<div class="table-wrap"><table class="wrapped confluenceTable"><colgroup><col/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey" title="Background colour : "><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope</strong></span></p></td></tr><tr><td class="confluenceTd"><p title=""><span style="letter-spacing: 0.0px;color: rgb(51,51,51);">Comparing Analysis Method Implementations in Software (CAMIS) has evolved from the Clinical Statistical Reporting in a Multilingual World project.</span></p><p title=""><span style="color: rgb(51,51,51);">Several discrepancies have been discovered in statistical analysis results between different programming languages, even in fully qualified statistical computing environments. Subtle differences exist between the fundamental approaches implemented by each language, yielding differences in results which are each correct in their own right. The fact that these differences exist causes unease on the behalf of sponsor companies when submitting to a regulatory agency, as it is uncertain if the agency will view these differences as problematic. Understanding the agency’s expectations will contribute significantly to enabling the broader adoption of multiple programming languages in the production of data submission packages for regulatory review</span></p><p title=""><span style="color: rgb(51,51,51);">The CAMIS project seeks to clearly define this problem and provide a framework for assessing the fundamental differences for a particular statistical analysis across languages. In this context, the risk of interpreting numerical differences in analysis results due solely to differences in programming language can be mitigated, instilling confidence in both the sponsor company and the agency during the review period. This will be accomplished by:</span></p><ol title=""><li><p><span style="color: rgb(51,51,51);">Identifying common statistical analyses performed during submissions to narrow the scope of where discrepancies must be identified (e.g., continuous summaries, frequency counts, hazard models, bioequivalence testing, steady-state assessments, bioavailability testing, ANOVA)</span></p></li><li><p><span style="color: rgb(51,51,51);">Providing necessary documentation to produce equivalence in results between separate statistical analysis software packages/languages (where possible)</span></p></li><li><p><span style="color: rgb(51,51,51);">Evaluating and documenting differences in results between popular statistical analysis implementations as use cases</span></p></li><li><p><span style="color: rgb(51,51,51);">Provision of sample code for use cases through a publicly accessible code repository for both review and consumption</span></p></li><li><p><span style="color: rgb(51,51,51);">Promoting the notion that the ‘right’ implementation of a particular statistical analysis should be based sound statistical reasoning and not limited by the capabilities of a specific programming language or statistical analysis software package, nor its default settings</span></p></li></ol><p><span style="color: rgb(51,51,51);">The <span style="color: rgb(51,102,255);"><a class="external-link" href="https://psiaims.github.io/CAMIS/" rel="nofollow" style="color: rgb(51,102,255);">CAMIS repository</a></span> to document known differences is now live and open for community contributions. </span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 50.2755%;"/><col style="width: 49.7245%;"/></colgroup><tbody><tr><th class="confluenceTh"><h4 id="ComparingAnalysisMethodImplementationsinSoftware(CAMIS)-ProjectLeads"><span style="color: rgb(51,51,51);">Project Leads</span></h4></th><th class="confluenceTh"><h4 id="ComparingAnalysisMethodImplementationsinSoftware(CAMIS)-Email"><span style="color: rgb(51,51,51);">Email</span></h4></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Lyn Taylor,<em> Parexel</em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="mailto:yn.taylor@parexel.com" rel="nofollow">lyn.taylor@parexel.com</a> </span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Christina Fillmore, <em>GSK</em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="mailto:christina.e.fillmore@gsk.com" rel="nofollow">christina.e.fillmore@gsk.com</a></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><span style="color: rgb(33,33,33);text-decoration: none;">Harshal Khanolkar, <em>Novo Nordisk</em></span></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="mailto:hlsk@novonordisk.com" rel="nofollow">hlsk@novonordisk.com</a></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Kerry Robson, <em>PHUSE Project Assistant</em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</p></div></th></tr><tr><td class="confluenceTd"><div class="content-wrapper"><p>Launched CAMIS-ONCO. Expanded membership and industry awareness of the project. Increased content loaded into the repository <a class="external-link" href="https://psiaims.github.io/CAMIS/" rel="nofollow">CAMIS (psiaims.github.io)</a></p></div></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 65.5052%;"/><col style="width: 34.4948%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Timelines</span></th></tr><tr><td class="confluenceTd"><p class="p1"><span style="color: rgb(51,51,51);">Expand repository to provide comparable syntax across languages (based on R and SAS use cases as a starting point)</span></p></td><td class="confluenceTd"><p class="p2"><span style="color: rgb(51,51,51);">Q2 2023</span></p></td></tr><tr><td class="confluenceTd"><p class="p1"><span style="color: rgb(51,51,51);">Expand GitHub repository to incorporate Python and/or Julia</span></p></td><td class="confluenceTd"><p class="p2"><span style="color: rgb(51,51,51);">Q3 2023</span></p></td></tr><tr><td class="confluenceTd"><p class="p1"><span style="color: rgb(51,51,51);">White Paper providing framework for addressing language discrepancies in statistical analysis implementations, including specific use cases as examples</span></p></td><td class="confluenceTd"><p class="p2"><span style="color: rgb(51,51,51);">Ongoing</span></p></td></tr></tbody></table></div></div>
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</div>Kerry Robson2020-10-29T09:33:45ZClinical Visual Analytics for Review and Submission (CVARS)Kerry Robsontag:advance.phuse.global,2009:page-327884-662024-03-28T16:01:49Z2020-10-29T09:46:00Z<div class="feed"> <p>
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<b>edited</b> by
<a href=" https://advance.phuse.global/display/~kerry
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup class=""><col class="" style="width: 50.1539%;"/><col class="" style="width: 49.8472%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><h4 id="ClinicalVisualAnalyticsforReviewandSubmission(CVARS)-ProjectLeads"><span style="color: rgb(51,51,51);">Project Leads</span></h4></th><th class="confluenceTh"><h4 id="ClinicalVisualAnalyticsforReviewandSubmission(CVARS)-Email"><span style="color: rgb(51,51,51);">Email</span></h4></th></tr><tr class=""><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Melvin Munsaka, <em>Abbvie</em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:melvin.munsaka@abbvie.com" rel="nofollow" style="color: rgb(51,102,255);">melvin.munsaka@abbvie.com</a></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Jiang (Jessica) Hu,<em> FDA</em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:jiang.hu@fda.hhs.gov" rel="nofollow" style="color: rgb(51,102,255);">jiang.hu@fda.hhs.gov</a></span></p></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Neetu Sangari, <em>Pragya Tech Leaders</em></span></td><td class="confluenceTd"><a class="external-link" href="mailto:neetusang@gmail.com" rel="nofollow">neetusang@gmail.com</a></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Kerry Robson,<em> PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 99.93036%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey" title="Background colour : "><div class="content-wrapper" title=""><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span><strong> Q1 2024</strong></span></p></div></td></tr><tr><td colspan="1" class="confluenceTd"><ul><li>Participation at the CSS</li><li>Presentation at the FDA</li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup class=""><col class="" style="width: 68.7892%;"/><col class="" style="width: 31.1434%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Timelines</span></th></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">An open-source R Shiny tool for generating the plots and associated outputs and an accompanying paper for the tool</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q3 2022</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Complete manuscript</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q4 2024</span></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.9141%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th scope="col" class="confluenceTh"><span style="color: rgb(51,51,51);">Resources </span></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,102,255);text-decoration: none;"><a class="external-link" href="https://github.com/phuse-org/aesummaries" rel="nofollow" style="color: rgb(51,102,255);">CVARS GitHub Page</a></span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,102,255);text-decoration: none;"><a class="external-link" href="https://phuse-org.shinyapps.io/aesummaries/" rel="nofollow" style="color: rgb(51,102,255);">CVARS</a></span></td></tr></tbody></table></div></div>
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</div>Kerry Robson2020-10-29T09:46:00ZBest Practices for Interactive Analysis for Decision Making SubmissionsKerry Robsontag:advance.phuse.global,2009:page-327872-902024-03-28T16:01:16Z2020-10-28T15:59:52Z<div class="feed"> <p>
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<b>edited</b> by
<a href=" https://advance.phuse.global/display/~kerry
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<p><span class="confluence-embedded-file-wrapper image-left-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image image-left" draggable="false" width="1050" src="https://advance.phuse.global/download/attachments/327872/Data%20Vis%20and%20Open%20Source%20Banner.jpg?version=1&modificationDate=1608115866140&api=v2" data-image-src="https://advance.phuse.global/download/attachments/327872/Data%20Vis%20and%20Open%20Source%20Banner.jpg?version=1&modificationDate=1608115866140&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="4358305" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="Data Vis and Open Source Banner.jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="327872" data-linked-resource-container-version="90" alt=""></span></p></div>
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<p><br/></p><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="letter-spacing: 0.0px;width: 100.0%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey" title="Background colour : "><p class="p1" title=""><span style="color: rgb(51,51,51);"><strong>Project Scope</strong></span></p></td></tr><tr><td class="confluenceTd"><p class="p1"><span style="letter-spacing: 0.0px;color: rgb(51,51,51);">Leverage Visual Analytics in our submission package to improve interactions between regulatory agencies and sponsors for a fast and effective review of submitted data and analyses.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col/><col/></colgroup><tbody><tr><th class="confluenceTh"><p><span style="color: rgb(51,51,51);">Project Leads</span></p></th><th class="confluenceTh"><p>Email</p></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Zachary Skrivanek,<em> Eli Lilly</em></span></p></td><td class="confluenceTd"><p><a class="external-link" href="mailto:skrivanek_zachary@lilly.com" rel="nofollow">skrivanek_zachary@lilly.com</a></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Xiangyun 'Sharon' Wang, <em>Genentech</em></span></p></td><td class="confluenceTd"><p><a class="external-link" href="mailto:wang.xiangyun@gene.com" rel="nofollow">wang.xiangyun@gene.com</a></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Raj Kiran Boddu, <em>Takeda</em></span></p></td><td class="confluenceTd"><p><a class="external-link" href="mailto:raj-kiran.boddu@takeda.com" rel="nofollow">raj-kiran.boddu@takeda.com</a></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Kerry Robson, <em>PHUSE Project Assistant</em></span></p></td><td class="confluenceTd"><p><a class="external-link" href="mailto:kerry@phuse.global" rel="nofollow">kerry@phuse.global</a></p></td></tr></tbody></table></div><div class="table-wrap"><table class="wrapped relative-table confluenceTable" style="width: 99.9331%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><ul><li>Publishing WP</li><li>Planning for the next stage of the project</li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.1561%;"><colgroup><col style="width: 59.0185%;"/><col style="width: 40.9115%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Timelines</span></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Complete the Docker POC Project </span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">On hold</span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Kick off the Docker pilot for a real submission </span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">On hold</span></td></tr><tr><td class="confluenceTd"><p class="p1"><span style="color: rgb(51,51,51);">White Paper on best practices for interactive analyses for decision making & submissions</span></p></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q1 2024</span></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 35.0352%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Published Deliverables</span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Advance/Data+Visualisation+and+Open+Source+Technology/PP16+.pdf" rel="nofollow" style="color: rgb(51,51,51);">Best Practice for Interactive Analysis for Submission</a> – CSS Poster 2020</span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="https://www.phusewiki.org/docs/WorkingGroups/Containers@Bayer_abridged.pdf" rel="nofollow" style="text-decoration: underline;color: rgb(51,51,51);">DevOps in Action, Containers@Bayer</a>- Presentation by Karl Brand 21-03-19</span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Advance/Data+Visualisation+and+Open+Source+Technology/Interactive+Data+Visualizations+for+Decision+Making+in+Submissions+%E2%80%93%C2%A0PHUSE+Webinar.pdf" rel="nofollow" style="color: rgb(51,51,51);">Interactive Data Visualisations for Decision Making in Submissions</a> – PHUSE Webinar Wednesday 2019</span></p></td></tr></tbody></table></div></div>
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</div>Kerry Robson2020-10-28T15:59:52ZSubmitting Real World DataNicola Newtontag:advance.phuse.global,2009:page-68943999-542024-03-28T13:47:51Z2023-04-06T00:04:52Z<div class="feed"> <p>
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<b>edited</b> by
<a href=" https://advance.phuse.global/display/~nicky
">Nicola Newton</a>
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<p><a href="https://advance.phuse.global/x/eQAcB" rel="nofollow"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" width="1050" src="https://advance.phuse.global/download/attachments/68943999/RWE%20WG.jpg?version=1&modificationDate=1680803322318&api=v2" data-image-src="https://advance.phuse.global/download/attachments/68943999/RWE%20WG.jpg?version=1&modificationDate=1680803322318&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="68944005" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="RWE WG.jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="68943999" data-linked-resource-container-version="54" alt=""></span></a></p></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.4141%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope </strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The scope of the project includes developing collaterals for submission of real-world data through mutual discussion, knowledge and experience sharing by industry colleagues. The collaterals will be developed by undertaking research of existing draft guidance documents on real-world evidence by regulatory bodies, and by analysing members’ lessons learnt from completed case studies. The scope of this project will include submission of real-world data obtained from primary and widely used real-world data sources. These may include key electronic health record sources, patient reported outcomes, widely used and accepted claims data sources, and other commonly used observational data. This project will also touch upon the data curation and ingestion processes pertaining to clinical operational as well as submission data. Since real-world data can come from a wide variety of sources, the scope of this project will consider the widely and most commonly used real-world data sources by industry and member companies.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.4141%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Problem Statement</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The pharmaceutical and biotech industry has witnessed incremental use of real-world data in the clinical trial and overall drug development process. As per the latest survey, close to 70% of clinical trials now use some form of real-world data. Based on the message from the FDA at the PHUSE/FDA CSS 2022, real-world evidence will be a primary focus of the FDA in 2023 and 2024. Although there are draft guidance documents from the FDA about submission of real-world data, there is a need to have a more detailed framework and direction to industry regarding submission of real-world data to regulatory bodies. This project aims to focus on developing collaterals which pharma industry, CROs and technology vendors can utilise for submission of real-world data to regulatory bodies.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.4141%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p><span style="color: rgb(51,51,51);"><strong>Problem Impact</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">This project plans to develop a submission-guidance-specific white paper for different types of real-world data including but not limited to EMR, claims data, patient reported outcomes and other observational data. These collaterals are aimed to assist the industry in making informed decisions while submitting real-world data to regulatory bodies. The project deliverables will be built upon the work completed by the <span style="color: rgb(51,102,255);"><a href="https://advance.phuse.global/x/pAAF" rel="nofollow" style="color: rgb(51,102,255);">Real World Evidence</a></span> project and all efforts here will be in coordination with the Real-world Evidence team.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.0399%;"><colgroup><col style="width: 52.404%;"/><col style="width: 47.5574%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Email </span></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Parag Shiralkar, <em>Sumptuous Data Sciences</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:parag.shiralkar@sumptuous-ds.com" rel="nofollow" style="color: rgb(51,102,255);">parag.shiralkar@sumptuous-ds.com</a></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Priyadarshini Tunga, <em><span style="letter-spacing: 0.0px;">IQVIA</span></em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:priyadarshini.tunga@iqvia.com" rel="nofollow" style="color: rgb(51,102,255);">priyadarshini.tunga@iqvia.com</a></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Nicola Newton, <em>PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><a class="external-link" href="mailto:nicky@phuse.global" rel="nofollow">nicky@phuse.global</a> </p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.9291%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><ul><li><p><span style="color: rgb(51,51,51);">Submitted a blog on challenges faced in the industry dealing with RWD</span></p></li><li><p><span style="color: rgb(51,51,51);"><span style="letter-spacing: 0.0px;">Checklist </span><span style="letter-spacing: 0.0px;">has been</span><span style="letter-spacing: 0.0px;"> written and</span><span style="letter-spacing: 0.0px;"> is</span><span style="letter-spacing: 0.0px;"> in </span><span style="letter-spacing: 0.0px;">the </span><span style="letter-spacing: 0.0px;">review stage</span></span></p></li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.9291%;"><colgroup class=""><col class="" style="width: 52.3558%;"/><col class="" style="width: 47.6465%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><h4 id="SubmittingRealWorldData-Objectives&Deliverables">Objectives & Deliverables</h4></th><th class="confluenceTh"><h4 id="SubmittingRealWorldData-Timelines">Timelines</h4></th></tr><tr class=""><td class="confluenceTd">Project kick off</td><td class="confluenceTd">Q2 2023 </td></tr><tr class=""><td class="confluenceTd">Decision Tree on how to submit the real-world data</td><td class="confluenceTd">Q4 2023</td></tr><tr class=""><td class="confluenceTd">Checklist for things to consider while submitting real-world data</td><td class="confluenceTd">Q4 2023</td></tr><tr class=""><td class="confluenceTd">Standardised documentation templates if needed</td><td class="confluenceTd">TBD</td></tr><tr class=""><td class="confluenceTd">Overall road map of things leading to each deliverable submitted to the FDA</td><td class="confluenceTd">Q1 2024</td></tr></tbody></table></div></div>
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</div>Nicola Newton2023-04-06T00:04:52ZRWD Guideline for Programming and Analysis ProcessesNicola Newtontag:advance.phuse.global,2009:page-79036419-272024-03-28T13:46:36Z2023-07-07T13:52:55Z<div class="feed"> <p>
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<p><a href="https://advance.phuse.global/x/eQAcB" rel="nofollow"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" width="1050" src="https://advance.phuse.global/download/attachments/79036419/RWE%20WG.jpg?version=1&modificationDate=1688737975651&api=v2" data-image-src="https://advance.phuse.global/download/attachments/79036419/RWE%20WG.jpg?version=1&modificationDate=1688737975651&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="79036420" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="RWE WG.jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="79036419" data-linked-resource-container-version="27" alt=""></span></a></p></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.1944%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope </strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The project will bring together statistical programmers across pharma to collaborate and provide their input to create an RWE Guideline/White Paper for the industry.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.1944%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Problem Statement</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Many pharma and biotech companies have invested resources to develop their own company-specific real-world data policies. All these fragmented efforts deserve a wider platform to unite and come up with generalised cross-industry guidelines via further development and expert input. Focus should be given on refinement and conciseness. This might have the potential to shape the industry going forward.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.2494%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p><span style="color: rgb(51,51,51);"><strong>Problem Impact</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Over the last few years the prevalence of real-world data being recognised as a component of a successful drug development programme has significantly increased. Reviewers, approvers and the healthcare industry in general expect sponsors to provide evidence from these sources. The traditional clinical trial being the only method for drug development is no longer enough, and successful leveraging of these broader data sources – e.g. EHRs, registries, payer data, wearables – is now seen as integral in development programmes.</span></p><p><span style="color: rgb(51,51,51);">The proposed guideline/white paper seeks to guide statistical programmers in the approaches to take for studies where RWD is involved. It is an end-to-end resource which provides users with guidance on data sourcing, utilisation, transformation, standardisation and submission whilst educating users on the value of real-world evidence. It also emphasises how engagement and collaboration with functional stakeholders, namely data science, stats, epidemiology, DM and clinical programming can have a greater impact in those areas.</span></p><p><span style="color: rgb(51,51,51);">Successful operation of this guideline/white paper could increase efficiency, cost-effectiveness and collaboration amongst peers and stakeholders. </span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.7075%;"><colgroup><col style="width: 52.2771%;"/><col style="width: 47.718%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(0,51,102);"><span style="color: rgb(51,51,51);">Email</span> </span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Dhruba Sikdar, <em><span class="ui-provider biv biw c d e f g h i j k l m n o p q r s t bix biy w x y z ab ac ae af ag ah ai aj ak">Johnson & Johnson</span></em></span></p></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:DSikdar@its.jnj.com" rel="nofollow" style="text-decoration: underline;color: rgb(51,102,255);">D<span class="outlook-search-highlight">Sikdar</span>@its.jnj.com</a></span></p></td></tr><tr><td class="confluenceTd"><p class="p1"><span style="color: rgb(51,51,51);">Priyadarshini Tunga<span style="letter-spacing: 0.0px;">, <em>IQVIA</em> </span><em style="letter-spacing: 0.0px;"> </em></span></p></td><td class="confluenceTd"><p class="p1"><span style="color: rgb(51,102,255);"><span class="ui-provider bqq bqr blh bqs bqt bqu bqv bqw bqx bqy bqz bra brb brc brd bre brf brg brh bri brj brk brl brm brn bro brp brq brr brs brt bru brv brw brx"><a class="external-link" href="mailto:priyadarshini.tunga@iqvia.com" rel="nofollow" style="color: rgb(51,102,255);">priyadarshini.tunga@iqvia.com</a></span></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Nicola Newton, <em>PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><a class="external-link" href="mailto:nicky@phuse.global" rel="nofollow">nicky@phuse.global</a> </p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.7075%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><ul><li><span class="TextRun SCXW58591965 BCX0" style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW58591965 BCX0">Project kicked off</span></span></li><li><span class="TextRun SCXW58591965 BCX0" style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW58591965 BCX0">Sub-topics selected</span></span></li><li><span class="TextRun SCXW58591965 BCX0" style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW58591965 BCX0">Sub-team with team lead formed</span></span></li><li><span class="TextRun SCXW58591965 BCX0" style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW58591965 BCX0">Each sub</span><span class="NormalTextRun SCXW58591965 BCX0">-</span><span class="NormalTextRun SCXW58591965 BCX0">team do their own meeting and report in the bi-weekly project meetings</span></span></li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.7075%;"><colgroup class=""><col class="" style="width: 51.7984%;"/><col class="" style="width: 48.2027%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><h4 id="RWDGuidelineforProgrammingandAnalysisProcesses-Objectives&Deliverables"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></h4></th><th class="confluenceTh"><h4 id="RWDGuidelineforProgrammingandAnalysisProcesses-Timelines"><span style="color: rgb(51,51,51);">Timelines</span></h4></th></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Project kick-off</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q3 2023</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Production of guideline/white paper on real-world data </span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q1 2024</span></td></tr></tbody></table></div></div>
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</div>Nicola Newton2023-07-07T13:52:55ZReal World Evidence GuidanceNicola Newtontag:advance.phuse.global,2009:page-68944003-462024-03-28T13:45:44Z2023-04-06T00:28:18Z<div class="feed"> <p>
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<p><a href="https://advance.phuse.global/x/eQAcB" rel="nofollow"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" width="1050" src="https://advance.phuse.global/download/attachments/68944003/RWE%20WG.jpg?version=1&modificationDate=1680803613171&api=v2" data-image-src="https://advance.phuse.global/download/attachments/68944003/RWE%20WG.jpg?version=1&modificationDate=1680803613171&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="68944008" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="RWE WG.jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="68944003" data-linked-resource-container-version="46" alt=""></span></a></p></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.4141%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope </strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">This group is designed to serve as an open-source platform for addressing queries related to real-world data (RWD). We aim to create an environment similar to Stack Overflow, where you can receive answers to your questions. </span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.4141%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Problem Statement</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Every organisation has internal documents of learnings and best practices for conducting research with real-world data. This could take the form of database quirks, standard cohort definitions and preferred algorithms. There is currently no open-source alternative to the internal documents, which leads to duplicated errors, slower learning at the individual level and slower advancement of real-world evidence at the industry level.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.4141%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p><span style="color: rgb(51,51,51);"><strong>Problem Impact</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Having an open-source option for these learnings to be recorded and shared will lead to less duplication of effort, faster evolution of the real-world evidence space, and ultimately better insights for participants and patients. Stakeholders include data vendors, pharma and any other entity that uses real-world data.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.8183%;letter-spacing: 0.0px;"><colgroup><col style="width: 49.0811%;"/><col style="width: 51.0039%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Email </span></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">David Hood, <em>Axtria</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><a class="external-link" href="mailto:David.Hood@axtria.com" rel="nofollow" style="color: rgb(51,51,51);">David.Hood@axtria.com</a></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Nicola Newton, <em>PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><a class="external-link" href="mailto:nicky@phuse.global" rel="nofollow">nicky@phuse.global</a> </p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.8862%;"><colgroup><col style="width: 48.9121%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><ul><li><span style="color: rgb(51,51,51);">Project on hold</span></li></ul></td></tr></tbody></table></div><div class="table-wrap"><table class="wrapped confluenceTable"><colgroup><col/></colgroup><tbody><tr><th scope="col" class="confluenceTh"><span style="color: rgb(51,51,51);">Resources </span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);"><span style="letter-spacing: 0.0px;">A collection of frequently asked questions about using Real World Evidence has been compiled by the team. Check out the </span><a href="https://advance.phuse.global/pages/viewpage.action?pageId=80805923" rel="nofollow" style="letter-spacing: 0.0px;color: rgb(51,51,51);">Real World Evidence Guidance Q&A</a><span style="letter-spacing: 0.0px;"> page to see some of the teams' responses and the schedule of upcoming questions.</span></span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.0399%;"><colgroup class=""><col class="" style="width: 48.9179%;"/><col class="" style="width: 51.0448%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><h4 id="RealWorldEvidenceGuidance-Objectives&Deliverables"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></h4></th><th class="confluenceTh"><h4 id="RealWorldEvidenceGuidance-Timelines"><span style="color: rgb(51,51,51);">Timelines</span></h4></th></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Project kick off</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q2 2023</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Create 5 seed example Q&A posts</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q2 2023</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Abstract to be posted on PHUSE education website to raise awareness of this forum</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q3 2023</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Email/social media campaign to raise awareness</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q3 2023</span></td></tr><tr class=""><td class="confluenceTd"><span style="color: rgb(51,51,51);">Publish questions </span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Ongoing </span></td></tr></tbody></table></div></div>
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</div>Nicola Newton2023-04-06T00:28:18ZQuality and Reusability of Real World DataNicola Newtontag:advance.phuse.global,2009:page-68944002-452024-03-28T13:43:36Z2023-04-06T00:13:10Z<div class="feed"> <p>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.1944%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Project Scope </strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Within this project we will make a list of available data sources and pros and cons. We will discuss what documents and requirements we need to show the FDA in the pre-alignment meeting and we will try to point to or create an outline and/or requirements for those documents. If possible, we will align with the FDA on this.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.1944%;letter-spacing: 0.0px;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p title=""><span style="color: rgb(51,51,51);"><strong>Problem Statement</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Real-world data sources have been used for many years in the pharmaceutical industry. They are useful for validating research questions and protocol set-up, patient and centre selection, post-registry safety follow-up and market access. However, the use for regulatory submissions is new. For this, the requirements are more stringent and we need a robust process to assess quality, accuracy, appropriateness of the data and compliance to regulatory requirements. How are we going to set ourselves up for success?</span></p><p><span style="color: rgb(51,51,51);">We shall focus on:</span></p><ul><li><span style="color: rgb(51,51,51);">selecting the appropriate data source</span></li><li><span style="color: rgb(51,51,51);">ensuring the data sources are accurate and traceable</span></li><li><span style="color: rgb(51,51,51);">how we assess the quality of the data</span></li></ul><p><span style="color: rgb(51,51,51);">These are all questions that we will start to answer in this project. </span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.2494%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey"><p><span style="color: rgb(51,51,51);"><strong>Problem Impact</strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">A number of (real-world evidence parts of) submissions have been rejected because of a lack of power or representativeness. The FDA indicates that aligning with them before the start of a study is key to assessing whether the approach and source we are using is acceptable. Then, we need to have good funding for our assumptions. If we do not have this, we need to restart our design.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.7075%;"><colgroup><col style="width: 52.2771%;"/><col style="width: 47.718%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Email </span></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Berber Snoeijer, <em>ClinLine</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:b.snoeijer@clinline.eu" rel="nofollow" style="text-align: left;color: rgb(51,102,255);">b.snoeijer@clinline.eu</a></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">D Rama Kalyanamma, <em>ICON</em></span></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:rama.kalyanamma@docsglobal.com" rel="nofollow" style="color: rgb(51,102,255);">rama.kalyanamma@docsglobal.com</a></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Ashwin Rai, <em>Evidera</em></span></td><td class="confluenceTd"><p class="p1"><span class="s1" style="color: rgb(51,102,255);"><a class="external-link" href="mailto:ashwin.rai@evidera.com" rel="nofollow" style="color: rgb(51,102,255);">ashwin.rai@evidera.com</a></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Nicola Newton,<em> PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><a class="external-link" href="mailto:nicky@phuse.global" rel="nofollow">nicky@phuse.global</a> </p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.7075%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><ul><li><span class="TextRun SCXW75303384 BCX0" style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW75303384 BCX0">Draft blog</span><span class="NormalTextRun SCXW75303384 BCX0">.</span></span></li><li><span class="TextRun SCXW75303384 BCX0" style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW75303384 BCX0">P</span><span class="NormalTextRun SCXW75303384 BCX0">lanned white paper including the achievements thus far</span></span></li><li><span class="TextRun SCXW75303384 BCX0" style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW75303384 BCX0">Vendor engagement list and plans</span></span></li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 98.7075%;"><colgroup><col style="width: 51.7984%;"/><col style="width: 48.2027%;"/></colgroup><tbody><tr><th class="confluenceTh"><h4 id="QualityandReusabilityofRealWorldData-Objectives&Deliverables"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></h4></th><th class="confluenceTh"><h4 id="QualityandReusabilityofRealWorldData-Timelines"><span style="color: rgb(51,51,51);">Timelines</span></h4></th></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Project kick off</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q2 2023</span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">List of documents and requirements validating the right data source</span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q4 2023</span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Pre alignment meeting with regulatory agencies </span></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">Q4 2023 </span></td></tr></tbody></table></div></div>
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</div>Nicola Newton2023-04-06T00:13:10ZBest Data Practices for Rare Disease Patient Foundations and ResearchersNicola Newtontag:advance.phuse.global,2009:page-50135059-562024-03-28T13:42:16Z2022-09-06T11:23:17Z<div class="feed"> <p>
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<b>edited</b> by
<a href=" https://advance.phuse.global/display/~nicky
">Nicola Newton</a>
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<h4 id="BestDataPracticesforRareDiseasePatientFoundationsandResearchers-"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image confluence-external-resource" draggable="false" width="1050" src="https://advance.phuse.global/download/attachments/68943993/RWE%20WG.jpg?version=1&modificationDate=1680803774829&api=v2" data-image-src="https://advance.phuse.global/download/attachments/68943993/RWE%20WG.jpg?version=1&modificationDate=1680803774829&api=v2"></span></h4><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.6173%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><td class="highlight-grey confluenceTd" data-highlight-colour="grey" title="Background colour : "><p title=""><span style="color: rgb(51,51,51);"><strong><span style="letter-spacing: 0.0px;">Project Scope </span></strong></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">This project aims to create a guidance about best data practices for patient foundations and for researchers in the form of decision trees, graphics, short printable materials or videos.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.6761%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Statement </span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">The purpose of this Working Group is to create awareness and education about best practices for collecting regulatory quality data from the industry perspective, improving data quality, empowering patients and patient groups with knowledge and information, and building bridges between industry, academics and patient communities.</span></p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.6761%;"><colgroup><col style="width: 100.0%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Impact </span></th></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">This project will create greater partnerships between industry, researchers and the patient community. It will also help improve data collection, with the goal of the data being useful to the industry.</span></p></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 100.0%;"><colgroup><col style="width: 49.3%;"/><col style="width: 50.7%;"/></colgroup><tbody><tr><th class="confluenceTh"><span style="color: rgb(51,51,51);">Project Leads</span></th><th class="confluenceTh"><span style="color: rgb(51,51,51);">Email</span></th></tr><tr><td class="confluenceTd"><p>Sophia Zilber, <em>Alexion AstraZeneca Rare Disease, Cure Mito Foundation</em></p></td><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:sophia.zilber@alexion.com" rel="nofollow" style="color: rgb(51,102,255);">sophia.zilber@alexion.com</a></span></p></td></tr><tr><td class="confluenceTd"><p><span style="color: rgb(51,51,51);">Danielle Boyce, <em>Johns Hopkins University</em></span></p></td><td class="confluenceTd"><span style="color: rgb(51,102,255);"><a class="external-link" href="mailto:dboyce3@jhu.edu" rel="nofollow" style="color: rgb(51,102,255);">dboyce3@jhu.edu</a></span></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Paul Howard, <em style="letter-spacing: 0.0px;">Amicus Therapeutics</em></span></td><td class="confluenceTd"><p class="p1"><span class="s1" style="color: rgb(51,102,255);"><a class="external-link" href="mailto:phoward@amicusrx.com" rel="nofollow" style="color: rgb(51,102,255);">phoward@amicusrx.com</a></span></p></td></tr><tr><td class="confluenceTd"><span style="color: rgb(51,51,51);">Nicola Newton, <em>PHUSE Project Assistant</em></span></td><td class="confluenceTd"><p><a class="external-link" href="mailto:nicky@phuse.global" rel="nofollow">nicky@phuse.global</a> </p></td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.483%;"><colgroup><col style="width: 62.5512%;"/></colgroup><tbody><tr><th class="confluenceTh"><div class="content-wrapper"><p><span style="color: rgb(51,51,51);"><span class="status-macro aui-lozenge aui-lozenge-current">CURRENT STATUS</span> Q1 2024</span></p></div></th></tr><tr><td class="confluenceTd"><ul><li><span style="color: rgb(51,51,51);"><span class="NormalTextRun SCXW142260138 BCX0">Drafted </span><span class="NormalTextRun SCXW142260138 BCX0">a </span><span class="NormalTextRun SCXW142260138 BCX0">lay language</span><span class="NormalTextRun SCXW142260138 BCX0"> summary of recent FDA guidance</span></span></li></ul></td></tr></tbody></table></div></div>
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<div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.403%;"><colgroup><col style="width: 88.7926%;"/><col style="width: 11.2432%;"/></colgroup><tbody class=""><tr class=""><th class="confluenceTh"><h4 id="BestDataPracticesforRareDiseasePatientFoundationsandResearchers-Objectives&Deliverables"><span style="color: rgb(51,51,51);">Objectives & Deliverables</span></h4></th><th class="confluenceTh"><h4 id="BestDataPracticesforRareDiseasePatientFoundationsandResearchers-Timelines">Timelines</h4></th></tr><tr class=""><td class="confluenceTd">Decide on a strategy to share all three resources, possibly through PHUSE Education webinars </td><td class="confluenceTd">Q2 2023</td></tr></tbody></table></div><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.483%;"><colgroup class=""><col class="" style="width: 62.5512%;"/><col class="" style="width: 37.4546%;"/></colgroup><tbody class=""><tr class=""><td class="highlight-grey confluenceTd" colspan="2" data-highlight-colour="grey"><strong title="">Published Deliverables</strong></td></tr><tr class=""><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><span class="x_ContentPasted4"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Emerging+Trends+%26+Technologies/Myths+VS+Facts+About+Patient+Registries.pdf" rel="nofollow" style="color: rgb(51,102,255);">Myths VS Facts About Patient Registries</a></span></span></p></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">18 May 2023</span></td></tr><tr class=""><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Advance/Emerging+Trends+and+Technologies/PHUSE+Working+Group+Registry+Guide+Final.pdf" rel="nofollow" style="color: rgb(51,102,255);">Patient Foundations Guide to Starting a Registry</a></span></p></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">28 April 2023</span></td></tr><tr class=""><td class="confluenceTd"><p><span style="color: rgb(51,102,255);"><a class="external-link" href="https://phuse.s3.eu-central-1.amazonaws.com/Advance/Emerging+Trends+and+Technologies/PHUSE+Working+Group+Transparency+Final.pdf" rel="nofollow" style="color: rgb(51,102,255);">Patient Registry Transparency Checklist For Patient Foundations </a></span></p></td><td class="confluenceTd"><span style="color: rgb(51,51,51);">28 April 2023</span></td></tr></tbody></table></div></div>
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</div>Nicola Newton2022-09-06T11:23:17ZPHUSE/FDA CSS 2024Kerry Robsontag:advance.phuse.global,2009:page-80806741-442024-03-28T11:59:56Z2023-09-07T12:43:54Z<div class="feed"> <p>
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<a href=" https://advance.phuse.global/display/~kerry
">Kerry Robson</a>
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<p><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://advance.phuse.global/download/attachments/80806741/Banner%20%283%29.jpg?version=1&modificationDate=1701956242169&api=v2" data-image-src="https://advance.phuse.global/download/attachments/80806741/Banner%20%283%29.jpg?version=1&modificationDate=1701956242169&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="91750405" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="Banner (3).jpg" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/jpeg" data-linked-resource-container-id="80806741" data-linked-resource-container-version="44" alt=""></span></p></div>
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<div class="table-wrap"><table class="wrapped confluenceTable"><colgroup><col/></colgroup><tbody><tr><th class="highlight-#0052cc confluenceTh" data-highlight-colour="#0052cc" scope="col" title="Background colour : Dark blue 85%"><span style="color: rgb(255,255,255);" title="">Overview</span></th></tr><tr><td class="confluenceTd"><p>Are you ready to deepen your understanding of computational techniques and regulatory applications? <span>The annual PHUSE/FDA Computational Science Symposium (CSS) is an event at the forefront of the pharmaceutical industry’s commitment to innovation and collaboration. </span><span>Key highlights include cutting-edge research, interactive workshops, regulatory insights, networking opportunities and, of course, vital updates from the eight PHUSE</span><span> </span><a href="https://advance.phuse.global/display/WEL/Working+Groups" rel="nofollow" style="text-decoration: none;">Working Groups</a><span>. </span></p><p><span>Be a part of the change and join us 3–5 June at the Civic Center in Silver Spring, MD. Registration and call for posters is now open, please visit the <a class="external-link" href="https://www.phuse-events.org/attend/frontend/reg/tOtherPage.csp?pageID=27538&ef_sel_menu=2300&eventID=44" rel="nofollow">PHUSE website</a> for more information and key dates.</span></p></td></tr><tr><th class="highlight-#0052cc confluenceTh" data-highlight-colour="#0052cc" scope="col" title="Background colour : Dark blue 85%"><span style="color: rgb(255,255,255);"><span class="ui-provider ed cbl bnf cbm cbn cbo cbp cbq cbr cbs cbt cbu cbv cbw cbx cby cbz cca ccb ccc ccd cce ccf ccg cch cci ccj cck ccl ccm ccn cco ccp ccq ccr">Discover what’s happening at the CSS 2024!</span></span></th></tr><tr><td class="confluenceTd"><div class="content-wrapper"><p><span><span class="ui-provider ed cbl bnf cbm cbn cbo cbp cbq cbr cbs cbt cbu cbv cbw cbx cby cbz cca ccb ccc ccd cce ccf ccg cch cci ccj cck ccl ccm ccn cco ccp ccq ccr">Watch the video below where Chris Price, PHUSE Working Groups Director and CSS Chair, lets us into the exciting discussions, initiatives, and advancements awaiting you at this year's event.</span></span></p><p><a class="external-link" href="https://www.youtube.com/watch?v=vXNzfinVky4" rel="nofollow"><span class="confluence-embedded-file-wrapper image-center-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image image-center" draggable="false" height="250" src="https://advance.phuse.global/download/attachments/80806741/MicrosoftTeams-image%20%281%29.png?version=1&modificationDate=1710420254872&api=v2" data-image-src="https://advance.phuse.global/download/attachments/80806741/MicrosoftTeams-image%20%281%29.png?version=1&modificationDate=1710420254872&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="100270114" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="MicrosoftTeams-image (1).png" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/png" data-linked-resource-container-id="80806741" data-linked-resource-container-version="44" alt=""></span></a></p><p><span><span class="ui-provider ed cbl bnf cbm cbn cbo cbp cbq cbr cbs cbt cbu cbv cbw cbx cby cbz cca ccb ccc ccd cce ccf ccg cch cci ccj cck ccl ccm ccn cco ccp ccq ccr">Please note, this video was recorded in February. Visit the <a class="external-link" href="https://www.phuse-events.org/attend/frontend/reg/tOtherPage.csp?pageID=27538&ef_sel_menu=2300&eventID=44" rel="nofollow">PHUSE website</a> <span class="ui-provider ed cbl bnf cbm cbn cbo cbp cbq cbr cbs cbt cbu cbv cbw cbx cby cbz cca ccb ccc ccd cce ccf ccg cch cci ccj cck ccl ccm ccn cco ccp ccq ccr">for the most up to date agenda and contributor information.</span></span></span></p></div></td></tr></tbody></table></div></div>
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<p class="auto-cursor-target"><span style="color: rgb(255,255,255);"><strong>PHUSE FDA/ CSS 2023</strong></span></p><div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 1547.0px;"><colgroup><col style="width: 926.0px;"/><col style="width: 620.0px;"/></colgroup><tbody><tr><th class="highlight-#0052cc confluenceTh" colspan="2" data-highlight-colour="#0052cc" style="text-align: center;width: 1450.14px;"><div class="content-wrapper" title=""><p><span style="color: rgb(255,255,255);"><strong>CSS Chairs </strong></span></p></div></th></tr><tr><td colspan="2" style="text-align: center;" class="confluenceTd"><div class="content-wrapper" title=""><p><span style="color: rgb(255,255,255);"><strong><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" height="250" src="https://advance.phuse.global/download/attachments/80806741/Screenshot%202024-03-21%20at%2015.47.14.png?version=1&modificationDate=1711036090061&api=v2" data-image-src="https://advance.phuse.global/download/attachments/80806741/Screenshot%202024-03-21%20at%2015.47.14.png?version=1&modificationDate=1711036090061&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="100270217" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="Screenshot 2024-03-21 at 15.47.14.png" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/png" data-linked-resource-container-id="80806741" data-linked-resource-container-version="44" alt=""></span><br/></strong></span></p></div></td></tr></tbody></table></div> <div class="table-wrap"><table class="relative-table wrapped confluenceTable" style="width: 99.8719%;"><colgroup><col style="width: 34.3985%;"/><col style="width: 31.034%;"/><col style="width: 34.5464%;"/></colgroup><tbody><tr><th class="highlight-#0052cc confluenceTh" colspan="3" data-highlight-colour="#0052cc"><div class="content-wrapper" style="text-align: center;" title=""><span style="color: rgb(255,255,255);">CSS Contributors</span></div></th></tr><tr><td colspan="3" class="confluenceTd"><div class="content-wrapper"><h3 style="text-align: center;" id="PHUSE/FDACSS2024-"><span class="confluence-embedded-file-wrapper confluence-embedded-manual-size"><img class="confluence-embedded-image" draggable="false" width="750" src="https://advance.phuse.global/download/attachments/80806741/Screenshot%202024-03-28%20at%2011.59.09.png?version=1&modificationDate=1711627169761&api=v2" data-image-src="https://advance.phuse.global/download/attachments/80806741/Screenshot%202024-03-28%20at%2011.59.09.png?version=1&modificationDate=1711627169761&api=v2" data-unresolved-comment-count="0" data-linked-resource-id="101908481" data-linked-resource-version="1" data-linked-resource-type="attachment" data-linked-resource-default-alias="Screenshot 2024-03-28 at 11.59.09.png" data-base-url="https://advance.phuse.global" data-linked-resource-content-type="image/png" data-linked-resource-container-id="80806741" data-linked-resource-container-version="44" alt=""></span></h3><p style="text-align: center;"><span style="color: rgb(65,67,69);">For more information, or to sign up, please contact<span> </span></span><a class="external-link" href="mailto:events@phuse.global" rel="nofollow" style="text-decoration: none;">events@phuse.global</a><span style="color: rgb(65,67,69);">. </span></p></div></td></tr></tbody></table></div></div>
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