PHUSE2020·Connect·Regulatory Environment
Data Standards Used for Electronic Submission of Real-world Evidence in New Drug Applications (NDAs) SA03 US · Virtual
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Conference Papers
13,885
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10
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Papers
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PHUSE2020·Connect·Regulatory Environment
Getting It Right: Refinement of SEND Validation Rules SA05 US · Virtual
PHUSE2020·Connect·Regulatory Environment
A Case Study: Data Transparency of Clinical Trial Data SA06 US · Virtual
PHUSE2020·Connect·Regulatory Environment
Regulatory Scrutiny on Data Integrity: Are You Safe? SA07 US · Virtual
PHUSE2020·Connect·Regulatory Environment
An Update on CDISC-SEND Data Submissions to the FDA SA08 US · Virtual
PHUSE2020·Connect·Regulatory Environment
Developing SEND for CBER – Collaborative Workstream Initiative Update SA10 US · Virtual
PHUSE2020·Connect·Regulatory Environment
Programmatic Generation of Health Canada's Comparative Bioavailability Information Appendix B SA11 US · Virtual
PHUSE2020·Connect·Regulatory Environment
Managing Simultaneous Drug Submissions with Breakthrough Designations – Lessons Learned from a Programming Perspective SA12 US · Virtual
PHUSE2020·Connect·Regulatory Environment
Getting Closer to Multi-regional Clinical Trials SA13 US · Virtual
PHUSE2020·Connect·Regulatory Environment
Industry Experiences Submitting Standardized Study Data to Regulatory Authorities SA14 US · Virtual
PHUSE2020·Connect·Technology & Applications
Breaking Boundaries: Working Across Different Workspaces in LSAF AD09 EU · Virtual
PHUSE2020·Connect·Technology & Applications
R Shiny for Exploratory Analysis of Phase III Trial Results AD16 EU · Virtual
PHUSE2020·Connect·Technology & Applications
SPA – A Catalyst for Clinical Protocol Development SD02 US · Virtual
PHUSE2020·Connect·Technology & Applications
CDISC Library Try-out: From Implementation to Evaluation of the API SD05 US · Virtual
PHUSE2020·Connect·Technology & Applications
Analysis Studio: A Tool Framework for Supporting Regulatory Review SD10 US · Virtual
PHUSE2020·Connect·Technology & Applications
Quarterly Safety Reporting: Timely Analysis of Clinical Safety Data Using Qlik Sense Software SD11 US · Virtual