PHUSE2019·Connect·Programming Languages
An Efficient Way to Combine RTF Files and Create Multi-level Bookmarks and a Hyperlinked TOC SM05 EU · Amsterdam
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Conference Papers
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Showing 2001–2020 of 3,683
PHUSE2019·Connect·Programming Languages
Adapting the SAS Enterprise Guide Log Summary to Check Your LOG for You SM06 EU · Amsterdam
PHUSE2019·Connect·Programming Languages
Automating Validation of Statistical Reports – A Real Case Study SM07 EU · Amsterdam
PHUSE2019·Connect·Regulatory Environment
The EMA, Health Canada and the FDA: Three Agencies Tackle Data Sharing: Synergies and Differences SA01 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Development of the Standard BIMO Process to Create the Clinsite Dataset SA01 EU · Amsterdam
PHUSE2019·Connect·Regulatory Environment
Machine-readable Data Not Required for the EMA...Really? SA02 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Lessons Learned from an FDA Real- time Oncology Review Pilot Programme: A Novartis & Roche Perspective SA02 EU · Amsterdam
PHUSE2019·Connect·Regulatory Environment
ADaM Submission – How to Work with the Inconsistencies Between the FDA and PMDA Requirements SA03 EU · Amsterdam
PHUSE2019·Connect·Regulatory Environment
High-quality Study Data Standards for Submission SA03 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Processing Big Data from Multiple Sources SA04 EU · Amsterdam
PHUSE2019·Connect·Regulatory Environment
Submission of Software Programs to Regulatory Agencies SA04 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Approach of Programming Production Harmonized with Submission SA05 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
How Metadata Can Help Drive the Creation of Tables, Figures and Listings SA05 EU · Amsterdam
PHUSE2019·Connect·Regulatory Environment
Developing SEND for CBER – Collaborative Workstream Initiative SA06 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Navigating FDA Requirements: ISS/ISE Build Strategies SA07 EU · Amsterdam
PHUSE2019·Connect·Regulatory Environment
The Benefits, Challenges and Myths of SEND SA07 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Identifying Hurdles for Submission of Electronic Nonclinical Data (SEND) SA08 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Impact of SEND Data on FDA Review of Nonclinical Studies SA09 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
Using CDISC-SEND Standardized Data in FDA Toxicology Review: The KickStart Service SA10 US · Baltimore
PHUSE2019·Connect·Regulatory Environment
The Clinical Data Specialist Role Within Regulatory Review SA13 US · Baltimore