PHUSE2018·Connect·Programming Languages
SAS and UNIX: Rerun Your Batches in a Smarter Way SM08 EU · Frankfurt
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Conference Papers
13,885
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10
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Papers
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PHUSE2018·Connect·Regulatory Environment
Achieving Highest Quality and Usability of SEND through Industry and Regulatory Collaboration RG01 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
Role of Associate Director of Biomedical Informatics in Clinical Review at the FDA RG02 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
Updates from the EMA Technical Anonymization Group & Policy 0070 RG04 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
BIMO Listings - Check That Off Your NDA To-Do List RG07 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
FDA View: Technical Rejection Criteria for Study Data RG09 US · Raleigh
PHUSE2018·Connect·Regulatory Environment
Use of Real-Time Application for Portable Interactive Device (RAPID) for Data safety and Patient Out RG11 US · Raleigh
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