PHUSE2025·Connect·Regulatory Environment
Management of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions SA03 US · Orlando
Official-source directory
Conference Papers
13,885
available papers
10
available conferences
Papers
Showing 1421–1440 of 13,885
PHUSE2025·Connect·Regulatory Environment
Health Authority Interactions and Communication During the Submission Process SA04 US · Orlando
PHUSE2025·Connect·Regulatory Environment
From Application to Approval: Exploring the FDA’s Review Process SA05 US · Orlando
PHUSE2025·Connect·Regulatory Environment
The Show Must Go On: Best Practices for Submitting SDTM Data for Ongoing Studies SA06 US · Orlando
PHUSE2025·Connect·Regulatory Environment
Regulatory Challenges and Strategies for AI/ML-Enabled Medical Device (SaMD) Data Submission SA07 US · Orlando
PHUSE2025·Connect·Regulatory Environment
Double Trouble: Essential Insights from Successful Dual sBLA Submissions for a Drug-Device Combo SA09 US · Orlando
PHUSE2025·Connect·Regulatory Environment
Regulatory Submissions – Exciting, Challenging, or Both? SA10 US · Orlando
PHUSE2025·Connect·Regulatory Environment
Optimising Regulatory Submissions: The Role of eCTD, Real-World Evidence and AI SA11 US · Orlando
PHUSE2025·Connect·Regulatory Environment
Optimising the Development and Regulatory Submission of an eSUB Package for Exposure-Response and PK/PD Analysis SA12 US · Orlando
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
A Git-Driven Automated Workflow for Efficient ADaM and TFL Validation and Quality Control Documentation SM01 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
Which Macros Are Used in the Study? SM02 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
Untangling the Dependencies Web SM03 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
More Science, Less Bookkeeping: Our Path to Hyper-Efficient ADaM Program Generation via AI, Process Improvements, and Good Old-Fashioned Programming SM04 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
Admiral-Enhanced Workflow: Automating SDTM to ADNCA Dataset Creation SM05 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
Why I Cant See Myself Coding That Much Anymore SM06 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
Code Compare A Machine Learning Based Framework for Code Plagiarism Analysis and Detection SM07 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
I Propose Aspose! Automating PDFs and Microsoft Office Files SM08 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
Automating RTF-to-PDF Conversion for BIMO Submissions: A Python-Based End-to-End Solution SM09 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
From Hassle to Harmony: Unifying Code Quality Experience in R and SAS SM10 EU · Hamburg
PHUSE2025·Connect·Scripts, Macros & Automation (SM)
%batchrunprograms: SAS Studio Background Submit on Multiple Programs SM11 EU · Hamburg