PHUSE2025·Connect·Programming LanguagesTable Numbers Presentation Made Easy with Custom Functions SM16 US · OrlandoSee metadata
PHUSE2025·Connect·Real-world Evidence (RE)Close Encounters with Real-World Data RE01 EU · HamburgSee metadata
PHUSE2025·Connect·Real-world Evidence (RE)FHIR for RWD Submissions: Why a US Regulation Signals a Global Shift And What You Need To Do Now RE02 EU · HamburgSee metadata
PHUSE2025·Connect·Real-world Evidence (RE)Beyond Tokenisation: Considerations for Linking Healthcare Data Sets for Scientific Research RE03 EU · HamburgSee metadata
PHUSE2025·Connect·Real-world Evidence (RE)Enhancing the Validation and Simulation of Real-World Multi-Site Data with R RE04 EU · HamburgSee metadata
PHUSE2025·Connect·Real-world Evidence (RE)Keeping it Real: A Tiered Approach to Real-World Data Quality by Leveraging Synthetic Data RE05 EU · HamburgSee metadata
PHUSE2025·Connect·Real-world Evidence (RE)Unlocking Healthcare Insights: Graph-Based Modelling and Analysis of Synthetic Patient Data RE06 EU · HamburgSee metadata
PHUSE2025·Connect·Regulatory EnvironmentManagement of Regulatory Referenced Deliverables Workshop ODS US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentE2E R Submission from a Roche Oncology Study SA01 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentManagement of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions SA03 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentHealth Authority Interactions and Communication During the Submission Process SA04 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentFrom Application to Approval: Exploring the FDA’s Review Process SA05 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentThe Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies SA06 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentRegulatory Challenges and Strategies for AI/ML-Enabled Medical Device (SaMD) Data Submission SA07 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentDouble Trouble: Essential Insights from Successful Dual sBLA Submissions for a Drug-Device Combo SA09 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentRegulatory Submissions – Exciting, Challenging, or Both? SA10 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentOptimising Regulatory Submissions: The Role of eCTD, Real-World Evidence and AI SA11 US · OrlandoSee metadata
PHUSE2025·Connect·Regulatory EnvironmentOptimising the Development and Regulatory Submission of an eSUB Package for Exposure-Response and PK/PD Analysis SA12 US · OrlandoSee metadata
PHUSE2025·Connect·Scripts, Macros & Automation (SM)A Git-Driven Automated Workflow for Efficient ADaM and TFL Validation and Quality Control Documentation SM01 EU · HamburgSee metadata
PHUSE2025·Connect·Scripts, Macros & Automation (SM)Which Macros Are Used in the Study? SM02 EU · HamburgSee metadata