PHUSE2018ConnectUS · RaleighRegulatory Environment
Role of Associate Director of Biomedical Informatics in Clinical Review at the FDA
Paper RG02
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Find papers in official PHUSE, PharmaSUG, WUSS, SESUG, and MWSUG proceedings. Search by title or paper number, then narrow the directory by conference, event, region, year, or category.
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PHUSE2018ConnectUS · RaleighRegulatory Environment
Confusing Data Validation Rules Explained
Paper RG03
PHUSE2018ConnectUS · RaleighRegulatory Environment
Updates from the EMA Technical Anonymization Group & Policy 0070
Paper RG04
PHUSE2018ConnectUS · RaleighRegulatory Environment
It's Time To Change
Paper RG06
PHUSE2018ConnectUS · RaleighRegulatory Environment
BIMO Listings - Check That Off Your NDA To-Do List
Paper RG07
PHUSE2018ConnectUS · RaleighRegulatory Environment
"What's Rules Got to Do with It?"
Paper RG08
PHUSE2018ConnectUS · RaleighRegulatory Environment
FDA View: Technical Rejection Criteria for Study Data
Paper RG09
PHUSE2018ConnectUS · RaleighRegulatory Environment
Use of Real-Time Application for Portable Interactive Device (RAPID) for Data safety and Patient Out
Paper RG11
PHUSE2018ConnectUS · RaleighRegulatory Environment
Assuring Data Integrity and Data Quality in Sponsor Submissions
Paper RG12
PHUSE2018ConnectUS · RaleighRegulatory Environment
The Changing Landscape of Data Quality at CDER: an Overview of the Core DataFitness Assessment
Paper RG13
PHUSE2018ConnectUS · RaleighRegulatory Environment
FDA CBER Data Standards Activity Update
Paper RG14
PHUSE2018ConnectUS · RaleighRegulatory Environment
Biomedical Informatics in the Office of New Drugs CDER/FDA
Paper RG15
PHUSE2018ConnectUS · RaleighRegulatory Environment
CDER’s Clinical Investigator Site Selection Tool
Paper RG16
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing, Synergies and Differences
Paper SA01
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
Challenges of Submitting Electronic Study Data to Two Authorities: The PMDA & FDA
Paper SA02
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
Standardised Data Sample: Key to Improving the Submission Strategy
Paper SA03
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
Dos and Don'ts of Define-XML
Paper SA04
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
How to Easily Generate Define.pdf from Define-XML – Submission Request
Paper SA05
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
Practical Lessons Learned from Recent NDA and BLA Submissions to the FDA
Paper SA06
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
Is it Possible to Make a Global CDISC Submission?
Paper SA07
PHUSE2018ConnectEU · FrankfurtRegulatory Environment
Lessons Learned for Successful e-Study Data Submission to the PMDA towards the End of the Transitional Period
Paper SA08
PHUSE2018ConnectEU · FrankfurtTechnology & Applications
Exchange of SAS Programs Between Local-/Server-Based SAS and the SAS Life Science Analytical Framework
Paper AD01
PHUSE2018ConnectEU · FrankfurtTechnology & Applications
Access Rights Management and Version Control in an Independent Programming Environment
Paper AD02
PHUSE2018ConnectEU · FrankfurtTechnology & Applications
An Efficient Way for Statistical Review Using RShiny Application
Paper AD03
PHUSE2018ConnectEU · FrankfurtTechnology & Applications
Automating SDTM – Get it Prepared with Your Voice
Paper AD04