Facilitating Clinical Data Management and Regulatory Review in the Pharmaceutical Industry: A Manager's Perspective
Source category: Conference paper
THE COMMUNITY ARCHIVE
Regulatory Submissions Papers and PresentationsPage 38
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.
747 papers · Showing 741–747
Requests Tracking System (RTS): A Facility for the Management of Post-NDA Regulatory Requests
Source category: Conference paper
Statistical Graphics in Environmental Regulatory Studies
Source category: Conference paper
The Laboratory Review System: A SAS-based Graphical and Statistical Tool Developed for a Computer-Assisted New Drug Application (CANDA) Submission
Source category: Conference paper
Author collections: David A. Bright · Russell R. Holmes
Are We Having Fun Yet? Human Factors in Designing a SAS/AF® Job Submission System
Source category: Conference paper
Author collections: Jeffrey C. Phillips · Todd Peer
Job Submission Menu (JSM): A Programming Tool to Standardize Clinical Trial Summarization
Source category: Conference paper
Author collections: Iraj Mohebalian
Automated Management of the Regulatory Aspects of the Development and Registration of Pharmaceutical Products
Source category: Conference paper