From Outsourced to Open Source: Denalis R-Driven Transformation in Biometrics
Source category: Submissions & Agencies (SA)
Author collections: Thomas Neitmann
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 6
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 101–120
From Topline to Triumph: Visualising the Pathways to Regulatory Approval
Source category: Poster Presentations
Author collections: Jasperlynn Kao
From XPT to Dataset-JSON: Enabling Real-Time Validation and Streamlined Submissions
Source category: Standards Implementation (SI)
Author collections: Sebastià Barceló
Guiding the Direction of Open-Source Development for Faster End-to-End HTA Submissions
Source category: Open Source Technologies (OS)
Author collections: Christian Olsen · Stephen McCawille
Handling Health Regulatory Information Requests: Best Practices and Strategies
Source category: Submission Standards
Author collections: Himanshu Patel · Chintan Pandya
Health Authority Interactions and Communication During the Submission Process
Source category: Submissions & Agencies
Author collections: Ritesh Dhimmar · Raman Bassi
Identification of Domains Containing Screen Failure Participants in SDTMs and ADaMs for Reviewer’s Guides
Source category: Submission Standards
Author collections: Sumanjali Mangalarapu
Intelligent Automation in Anonymisation for CTIS Submission
Source category: Machine Learning, AI and Large Language Models
Author collections: Pinku Hooda
JSON for Submissions: Why You Should Care, What You Need To Know, and What To Do Now
Source category: Standards Implementation (SI)
Author collections: Bill Qubeck · Sridhar Vijendra
Key guidelines, Tricks and Experiences for PMDA and comparison with FDA and CDE submission
Source category: Submission Standards
Author collections: Ramesh Potluri
Leveraging Health Technology Assessment (HTA) for Market Access: A Statistical Programming Perspective on German HTA Submission
Source category: Real World Evidence and Big Data
Author collections: Rachana Agarwal
Leveraging previous study data for Extension studies: Structuring Subject and Participant Level Analysis datasets using CRF data
Source category: Submission Standards
Life Cycle for the Management of ODS Regulatory Referenced Deliverables
Source category: Poster Presentations
Management of Regulatory Submissions Using eCTD Sequences and Life Cycle Operators: Lessons from Real-Time Oncology Review (RTOR) and Regular Submissions
Source category: Submissions & Agencies
Author collections: Elisabeth Pyle · Madhusudhan Reddy Papasani
ODS Management of Regulatory Referenced Deliverables Workshop
Source category: Regulatory Environment
Author collections: Christine Rossin · Randi McFarland
Oh Dear, Another Crisis? A Programmers Guide to Surviving and Thriving Through the FDA ODAC
Source category: Submissions & Agencies (SA)
Author collections: Zach Dorman
Optimising Regulatory Submissions: The Role of eCTD, Real-World Evidence and AI
Source category: Submissions & Agencies
Author collections: Kishore Pothuri
Optimising the Development and Regulatory Submission of an eSUB Package for Exposure-Response and PK/PD Analysis
Source category: Submissions & Agencies
Author collections: Saumil Tripathi
PDFs Done Right: The Statistical Programmer’s Guide to Flawless Regulatory Submissions
Source category: Submission Standards
Author collections: Srivathsa Ravikiran · Sri raghunadh Kakani
Poseidon: Streamlined Regulatory Screening of HA Websites with AI/ML to Extract Updates and Reduce Manual Efforts
Source category: Machine Learning, AI & Large Language Models (ML)