Effective Approach for ADaM Submission to FDA and PMDA
Source category: Submission Standards
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 17
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 321–340
Electronic Study Data (eData) Submission Experience to the PMDA and Collaboration between the Japan Submission Team and the Global Project Team
Source category: Submissions & Agencies
F3: Fitness, FAIR & Filing
Source category: Submissions & Agencies
Author collections: Bhupendra Mistry · Nigel Montgomery
FDA Conformance Analysis and Upcoming Implementation of Technical Rejection Criteria for Study Data
Source category: Regulatory Environment
Author collections: Ethan Chen · Heather Crandall
First Time Creating a Submission Package? Don’t Worry, We Got You Covered!
Source category: ePosters
Author collections: Lyma Faroz
Generating FDA-ready Submission Datasets directly from EHRs
Source category: Real World Evidence and Big Data
Author collections: Jozef Aerts
Good Cooperation Between SAS and R for Regulatory Submission
Source category: Strategy & Programming
Author collections: Jingyuan Chen
Harnessing Raw Data From Submission Forms to Gauge Food Insecurity Among College Students
Source category: SAS Global Forum proceedings
Legacy Data’s Journey: From Conversion to Electronic Data Submission Planning & Execution
Source category: Submissions & Agencies
Author collections: Sowmya Singuluri
Methods and Challenges of R Validation for Regulatory Submission Analysis
Source category: Trends & Technology
Author collections: Parveen Kumar
Multiple Successful Submissions of Medical Device Clinical Trial Data in the US and China using CDISC
Source category: Medical Devices
Author collections: Phil Hall
Navigating the Evolving Regulations for Health Canada
Source category: Submissions & Agencies
New Requirements of Clinical Trial Data Submission for China Filing: An Implementation
Source category: Submission Standards
Overview of the Submission Process for the FDA, EU and PMDA
Source category: Poster Presentation
Author collections: Nadeem Gul
Patient Registries – New Gold Standard for Real World Data
Source category: Submissions & Agencies
Author collections: Lavanya Peddibhotla · Sivasankar Konda
Pinnacle 21: Improving the Data Fitness Score for eSubmission
Source category: Standards Implementation
Preparing PK/PD ADaM Datasets and eCRTs Data Package for FDA Submission
Source category: Submissions & Agencies
Author collections: Junying Zhang
Process Optimization for Submissions Participating in the FDA’s Real Time Oncology Review Pilot Program
Source category: Poster Presentation
R Packages Management for Regulatory Compliance – Challenges and Solutions
Source category: Submissions & Agencies
Author collections: Pierre Wallet
Real-world Data, CDISC SDTM, HL7 FHIR and the Future of Regulatory Submissions
Source category: Real-world Evidence
Author collections: Jozef Aerts