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PHUSE/FDA CSS 2025 | ||
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In its 14th year, the PHUSE/FDA Computational Science Symposium (CSS) will be expanding its global reach! In addition to Silver Spring, Maryland, we will be running a simultaneous event in Utrecht, the Netherlands! Mark Your Calendars! The US event will be in Silver Spring, Maryland 19-21 May, and the EU event will be in Utrecht, the Netherlands 20-21 May. Please visit the PHUSE website for more information. Registration is now open!
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New Risk Based Quality Management Lead! |
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Please Welcome Jennifer Khron as a new Risk Based Quality Management lead. Jennifer Krohn, MS, currently serves as Associate Director, RBQM at Gilead Sciences. In her role, Jenn advises study teams on implementing risk-based monitoring strategies and leads initiatives working to develop enhanced technology and processes for centralised monitoring, risk assessments and site monitoring approaches. This role expands upon her 16 years’ experience in the CRO sector, where she spent a decade helping build centralised monitoring, leading data analyst teams and serving as QTL BPO. Prior to the RBQM space, Jenn worked in a variety of clinical trial roles across a wide range of therapeutic areas, from the site level as study coordinator, to the CRO side in clinical operations (CRA), data management and feasibility. Jenn previously co-led the Central Monitoring project, under the PHUSE RBQM Working Group. She holds a master’s degree in biology with a focus in biochemistry and physiology from the University of North Carolina Wilmington. |
Announcement - Emerging Trends and Technologies Working Group Has Changed its Name! |
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There’s been an exciting change in PHUSE Working Groups recently… The Emerging Trends and Technologies Working Group has officially evolved into the Emerging Trends and Innovation Working Group! Why the change? Working Group Lead Mike Hamidi shares what brought about this change of name and scope: "The name change from Emerging Trends & Technologies to Emerging Trends & Innovation reflects a broader focus beyond technological enablement. This shift encompasses ongoing developments in areas such as AI/ML, digital health technologies and healthcare standards and aims to provide deeper insights into these and other evolving topics. This adjustment will preserve the emphasis on emerging trends while enhancing our commitment to delivering valuable industry insights and innovations.” PHUSE is equally excited to welcome Mark Bynens, the new Working Group Lead. He joins Mike Hamidi and Stuart Malcolm, expanding the team’s expertise and capacity. Mark Bynens brings a wealth of experience as Director and Scientific Computing Operations (SCO) Head within Statistics & Decision Sciences (SDS), Global Development at Johnson & Johnson. Mark leads initiatives in change management, project management, education, high-performance computing, and statistical research. Learn more about the Working Group Leads and their efforts here: https://advance.hub.phuse.global/wiki/spaces/WEL/pages/26804666/Emerging+Trends+Innovation Would you like to get involved in Working Groups? Check out the new Advance Hub page to view all opportunities: https://advance.hub.phuse.global/wiki/spaces/WEL/pages/67993601/Project+Volunteer+Board |
Working Group Quarterly Report |
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We have just published the last Working Group Report for 2024! You can view the Quarter 4 summary here, including the project reports and some of the highlights across our Working Groups for this final quarter. Don’t forget to check out the Working Group Events Report too, which provides a breakdown of the data collected from the Working Group Events for 2024. Well done to all our Working Groups who have had a fantastic 2024! |
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