| Overview |
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Active since 2014, PHUSE’s Data Transparency Working Group provides subject matter expertise for the review of draft deliverables and guidance documents from regulatory bodies (such as the EMA and Health Canada), as well as other industry organisations (such as TransCelerate), and academia. Since their inception in 2020, the free-to-attend Data Transparency Events have gone from strength-to-strength. These virtual events have created an unrestrictive space where questions can be asked and challenges addressed. Individuals passionate about the area can come together to share vital knowledge, develop new ideas and spark innovation through presentations, panel discussions and Q&A sessions, alongside experts in the data sharing field. The PHUSE Data Transparency Winter Event will take place from 6–8 February 2024. Presenting at Data Transparency Event offers you the chance to share your knowledge and experience with the wider data transparency community, allowing them to come together to discuss new ideas and spark innovation! During this virtual event, presentations will be delivered across the three days in bitesize chunks from 15:00-17:30 (GMT). There will also be a panel discussion and Q&A session focused on the day's themes. Registration will open 4 January! |
| Speaker | Bio |
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| Bhavin Busa, Clymb Clinical Bhavin Busa is recognised as a thought leader in the areas of data standards, programming and regulatory submission. He is very passionate about leveraging standards and technology to expedite data review, analysis and submission processes. In line with his passion, Bhavin recently co-founded Clymb Clinical, a start-up that is driving innovation and revolutionising the clinical data industry through implementation of technology and open-source solutions. He devotes much of his time outside of his day job to volunteer with PHUSE and CDISC. He holds a position on the PHUSE Working Group Leadership Committee and serves on the CDISC Open-Source Alliance (COSA) Board. Additionally, Bhavin serves as a CDISC ARS Product Owner/Co-lead and will be chairing the PHUSE US Connect 2024. |
| Lauren Hepburn, Rare Disease Sponsor Lauren Hepburn is a Senior Clinical Trial Transparency Manager at a Rare Disease Sponsor. Lauren prepares clinical trial documents for submissions related to the European Clinical Trials Regulation (EU CTR), EMA Clinical Data Publication (Policy 0070), and Health Canada Public Release of Clinical Information (PRCI). Lauren is a member of the PHUSE Data Transparency Working Group and is currently co-leading the Good Transparency Practice project. She obtained her MSc in Biology and her BSc in Ecology and Evolutionary Biology. |
| Loganathan Ramasamy, AstraZeneca Logan completed B.Tech in Biotechnology from Anna university and MBA in International Business from Pondicherry University. He has over 14 years of experience in CRO/Pharma industry. Currently working with AstraZeneca as Associate Director, Statistical Programming under Early Biometrics & Statistical Innovation group. Before joining AZ, Logan was with IQVIA, LabCorp, Icon and Zifo, contributing to various functional activities like CRF Designing, Drug coding, Edit Check programming and Validation, JReview, Analysis & Reporting and Team management. |
| Michael Hedegaard Thomsen, Novo Nordisk Michael Hedegaard Thomsen is a Statistical Programming Specialist at Novo Nordisk and holds a M.Sc. in Statistics. He has been working in the IT industry since 1999, implementing large software solutions for both private and public sectors in Denmark and has experience with various programming languages and methodologies. For the last 8 years he has been working in the Pharma industry, primarily as trial programmer and participating in various cross project working groups. He is now a member of the Data Science Automation Group in Novo Nordisk. |
| Lynn Clipstone, PPD Lynn has been involved with PHUSE since 2012, when she first chaired the Professional Development Stream. In 2017/2018, Lynn led the PHUSE Working Group which developed the job description for a Clinical Data Scientist. Lynn was nominated to the position of Special Projects Director in 2022. |
| Ilan Carmeli, Beaconcure |
| DT Winter Event Sponsors |
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Virtual Event Sponsors
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| Sponsorship |
Hosting the Data Transparency Events digitally means that no matter where you are in the world you can participate. It provides the industry with a broader opportunity to share knowledge on a global scale, connecting through the virtual event platform. The sponsor options offer a range of benefits with ample company exposure. See the prospectus for more detail.
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| Data Transparency Working Group Leads |
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