PHUSE2018·Connect·Regulatory Environment
Use of Real-Time Application for Portable Interactive Device (RAPID) for Data safety and Patient Out RG11 US · Raleigh
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Conference Papers
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PHUSE2018·Connect·Regulatory Environment
Assuring Data Integrity and Data Quality in Sponsor Submissions RG12 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
The Changing Landscape of Data Quality at CDER: an Overview of the Core DataFitness Assessment RG13 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
Biomedical Informatics in the Office of New Drugs CDER/FDA RG15 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
CDER’s Clinical Investigator Site Selection Tool RG16 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing, Synergies and Differences SA01 EU · Frankfurt
PHUSE2018·Connect·Regulatory Environment
Challenges of Submitting Electronic Study Data to Two Authorities: The PMDA & FDA SA02 EU · Frankfurt
PHUSE2018·Connect·Regulatory Environment
Standardised Data Sample: Key to Improving the Submission Strategy SA03 EU · Frankfurt
PHUSE2018·Connect·Regulatory Environment
How to Easily Generate Define.pdf from Define-XML – Submission Request SA05 EU · Frankfurt
PHUSE2018·Connect·Regulatory Environment
Practical Lessons Learned from Recent NDA and BLA Submissions to the FDA SA06 EU · Frankfurt
PHUSE2018·Connect·Regulatory Environment
Is it Possible to Make a Global CDISC Submission? SA07 EU · Frankfurt
PHUSE2018·Connect·Regulatory Environment
Lessons Learned for Successful e-Study Data Submission to the PMDA towards the End of the Transitional Period SA08 EU · Frankfurt
PHUSE2018·Connect·Technology & Applications
Exchange of SAS Programs Between Local-/Server-Based SAS and the SAS Life Science Analytical Framework AD01 EU · Frankfurt
PHUSE2018·Connect·Technology & Applications
Access Rights Management and Version Control in an Independent Programming Environment AD02 EU · Frankfurt
PHUSE2018·Connect·Technology & Applications
An Efficient Way for Statistical Review Using RShiny Application AD03 EU · Frankfurt
PHUSE2018·Connect·Technology & Applications
Automating SDTM – Get it Prepared with Your Voice AD04 EU · Frankfurt
PHUSE2018·Connect·Technology & Applications
Programming Development and Validation Tracking Application “iTrack” AD05 EU · Frankfurt
PHUSE2018·Connect·Technology & Applications
Assembling PDF Reports with PROC Documents AD06 EU · Frankfurt