PHUSE2024·Connect·Programming Languages
Changing ODS Outputting Methods to Streamline the TFL Output Process SM10 EU · Strasbourg
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Conference Papers
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PHUSE2024·Connect·Programming Languages
A Practical Approach to Automating SDTM Using a Metadata-Driven Method that Leverages eCRF Specifications and SDTM Programming Standards SM10 US · Bethesda
PHUSE2024·Connect·Programming Languages
Leveraging GitHub Actions and Continuous Integration in R Package Qualification SM11 US · Bethesda
PHUSE2024·Connect·Programming Languages
How to Handle Huge Amounts of Output Tables – A Systematic Approach SM11 EU · Strasbourg
PHUSE2024·Connect·Programming Languages
Analysing Your SAS Log with User-Defined Rules Using an App or Macro SM12 EU · Strasbourg
PHUSE2024·Connect·Programming Languages
Streamlining the Integration of SDTM Datasets from Multiple Studies: A Macro Approach SM13 US · Bethesda
PHUSE2024·Connect·Programming Languages
Medidata RAVE and Veeva CDMS Data Extraction Macros SM13 EU · Strasbourg
PHUSE2024·Connect·Programming Languages
ID-SPECTACKLE: Making ADaM Specifications ‘Fun’ SM14 EU · Strasbourg
PHUSE2024·Connect·Programming Languages
Automate Your Metadata: Reading and Modifying Information from PDF Files Using Python SM15 EU · Strasbourg
PHUSE2024·Connect·Regulatory Environment
Speeding Up Submissions – Assessing the Business Value, Feasibility and Risk of New and Emerging Approaches SA02 US · Bethesda
PHUSE2024·Connect·Regulatory Environment
Streamlining MHRA Inspection Preparation and Execution in CROs SA03 EU · Strasbourg
PHUSE2024·Connect·Regulatory Environment
Making SDTM/ADaM CRT Packages Submission Ready SA04 EU · Strasbourg
PHUSE2024·Connect·Regulatory Environment
A SAS Tool for Generating Adverse Event Summaries in XML Format Using ADaM Datasets ADSL and ADAE for ClinicalTrial.gov and EudraCT Submissions SA04 US · Bethesda
PHUSE2024·Connect·Regulatory Environment
A Review of Open Source in New Drug Applications: Current Trends SA05 US · Bethesda
PHUSE2024·Connect·Regulatory Environment
Navigating First Data Submission: Pierre Fabre’s Journey and Insights into Data Submission Challenges with the NMPA SA05 EU · Strasbourg
PHUSE2024·Connect·Regulatory Environment
Exploring the Potential Use of Generative AI in the Regulatory Review Process SA06 US · Bethesda
PHUSE2024·Connect·Regulatory Environment
Harmonising FDA and PMDA Submission Requirements SA06 EU · Strasbourg