Janus Clinical and Nonclinical Loading: The Most Common Issues Identified from Sponsor Submissions
Source category: Data Handling
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 27
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 521–540
Lessons Learned for Successful e-Study Data Submission to the PMDA towards the End of the Transitional Period
Source category: Submissions & Agencies
Author collections: Takashi Kitahara
Macro tool to reduce the size of the datasets for FDA and Regulatory submissions
Source category: Conference paper
The publisher lists this presentation without a downloadable paper.
Author collections: Prabhakara Burma
Modernising the New Drug Regulatory Program at the FDA/CDER
Source category: Submissions & Agencies
Author collections: Lilliam Rosario
Practical Lessons Learned from Recent NDA and BLA Submissions to the FDA
Source category: Submissions & Agencies
Author collections: Carey Smoak · Lisa Brooks
Preparing the Office of Scientific Investigations (OSI) Requests for Submissions to FDA
Source category: ePosters
Author collections: Yaling Teng · Ran Li
Preparing to Meet FDA Requirements for Submission of Standardized Data and Documentation
Source category: Submission Standards
Author collections: Steven Kirby · Mario Widel
Proactive Role of a Lead Programmer Could Help Prevent Potential Delay in Submission
Source category: Leadership
Author collections: Ranjith Kalleda
Programmer’s Guide for OSI Deliverables – Creation of Site Level Summary Dataset and Automation of BIMO Listins Generation
Source category: Submission Standards
Author collections: Charanjit Kahlon · Bhavin Busa · Dharmendra Tirumalasetti
Ready Set Go: Planning and Preparing a CDISC Submission
Source category: Strategy in Programming
Author collections: Maria Dalton
Regulatory Compliance in the digital age – A cloud-based statistical computing environment (SCE) to the rescue
Source category: Strategic Implementation
Author collections: Sridhar Vijendra · Tyagrajan Swaminathan
Review programs used for submission and their input to the define-XML 2.0
Source category: Submission Standards
Author collections: Ari Knoph
Role of Associate Director of Biomedical Informatics in Clinical Review at the FDA
Source category: Regulatory
Author collections: Nhi Beasley
Standardised Data Sample: Key to Improving the Submission Strategy
Source category: Submissions & Agencies
Author collections: Prafulla Girase · Joanna Koft
Stay ahead of the game: Know the SDTM compliance check reject messages before creating your SDTM datasets
Source category: Submission Standards
Author collections: Lixiang Liu · Yuqin Li
The Changing Landscape of Data Quality at CDER: an Overview of the Core DataFitness Assessment
Source category: Regulatory
Author collections: Crystal Allard · MARGO COHEN
The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing, Synergies and Differences
Source category: Submissions & Agencies
Author collections: Jean-Marc Ferran
The Use of SDTM Standards for Non-submission Purposes
Source category: Data Standards & Governance
Author collections: Paul Vervuren · Lieke Gijsbers
Trial Summary: The Golden Gate towards a Successful Submission
Source category: Submission Standards
Author collections: Bhargav Koduru · Girish Kankipati
Updates from the EMA Technical Anonymization Group & Policy 0070
Source category: Regulatory
The publisher-listed Slides file is currently unavailable.
Author collections: Chris Decker