Good Cooperation Between SAS and R for Regulatory Submission
Source category: Trends & Technology
Author collections: Jingyuan Chen
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 20
Browse practical work on assembling, validating and documenting clinical data for regulatory review. Conference examples reflect their publication date; consult current agency guidance when deciding how an approach applies to a new submission.
622 papers · Showing 381–400
Guide to Electronic Submission of Pharmacometric Datasets and Analyses to the Regulatory Authorities
Source category: Submissions & Agencies
Handling Duplicate Records in SDTM for Effective Resolution and Explanation in Data Submission
Source category: Data Standards and Governance
Author collections: Varun Debbeti
How to Handle the Challenges for the Content of Specific Datasets in FDA Submission for HIV Drugs
Source category: Data Standards and Governance
Improving the Quality of Define.xml: A Comprehensive Checklist Before Submission
Source category: Submission Standards
Industry Experiences Submitting Standardized Study Data to Regulatory Authorities
Source category: Submissions & Agencies
Author collections: Janet Low · Vincent Guo
Innovation in Exploratory/Regulatory Clinical Trial Analyses
Source category: Submissions & Agencies
Author collections: Tadeusz Lewandowski
Managing Simultaneous Drug Submissions with Breakthrough Designations – Lessons Learned from a Programming Perspective
Source category: Submissions & Agencies
NMPA Submission (Data Submission in China)
Source category: Submissions & Agencies
Author collections: Marianne Carames
Pinnacle 21 Community v3.0 – A Users Perspective
Source category: Submission Standards
Author collections: Ajay Gupta
Pooling Lab Data to Support FDA Submission: Keep it Clear and Simple
Source category: Standards Implementation
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Preparing a Successful BIMO Data Package
Source category: Submission Standards
Author collections: Elizabeth Li · Carl Chesbrough · Inka Leprince
Preparing for FDA and PMDA Submission Simultaneously – What to Leverage, How to Deal with the Differences Efficiently
Source category: Submissions & Agencies
Author collections: Jasmine Kestemont
Preparing the HIV-1 Resistance Dataset for FDA Submission Based on the Guidelines for Better Understanding
Source category: Data Standards and Governance
Author collections: Jagadish Katam
Programmatic Generation of Health Canada's Comparative Bioavailability Information Appendix B
Source category: Submissions & Agencies
Author collections: Michael Rimler
Real-time Oncology Review – Applicant Experience
Source category: Submissions & Agencies
Regulatory Report Automation with R
Source category: Software Demonstration
Author collections: Suwen Li
Regulatory Scrutiny on Data Integrity: Are You Safe?
Source category: Submissions & Agencies
Author collections: Chris Decker
Replicating the CDISC Pilot Project Submission Project Using R and pharmaRTF
Source category: Trends & Technology
Author collections: Michael Stackhouse
RTOR: Our Side of the Story
Source category: Submission Standards
Author collections: Shefalica Chand