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Webinar Archive Topics Include:

  • One Stop Solution for Your Authoring Document, Management and Submission Publishing Needs
  • CDISC ADaM – Maturing of the Analysis Data Standard
  • Preparing a Compliant Data Package for Regulatory eCTD Submission
  • Submission Compliant Clinical Data Deliverables
  • Ask the Experts
  • Overview of ICH E9: Statistical Principles for Clinical Trials
  • The 5 Most Important Clinical SAS Programming Validation Steps
  • Data Standards Implementation Webinar Series 2 – Part 1
  • Good Document Practices
  • Data Standards Implementation Webinar Series: Part 2
  • Formatting Pitfalls and Why You Need to Care Webinar
  • StartingPoint as the Foundation of Document Standards
  • Data Standards Implementation Part-1
  • Document Formatting Webinar Series - Part 2
  • Document Formatting Webinar Series - Part 1
  • Avoiding the Pitfalls of Document Management
  • Document and Submission Management Solutions for Small Companies, Session 2
  • Conquering the Global Electronic Submissions Landscape
  • Electronic Submission FAQs Web Seminar
  • Good Document Practices
  • Data Profiling Techniques That Benefit Your SDTM Data Conversion
  • Data Profiling Techniques That Benefit Your SDTM Data Conversion
  • 10th Anniversary of Electronic Submissions
  • eCTD: Easing the Transition
  • The 5 Biggest Challenges of eCTD
  • Software as a Service (SaaS)
  • What's All the FUSE About
  • Clinical Information Standards Governance: Applying Standards Throughout the Clinical Data Lifecycle and Across the Enterprise
  • What's All the FUSE About
  • Data Validation: Going Beyound Standard Checks
  • eCTD Easing the Transition
  • Clinical Information Standards Governance: Applying Standards Throughout the Clinical Data Lifecycle and Across the Enterprise
  • Regulatory Submissions and Advisory Committee Meetings Series: Preparing Your Organization for Success
  • Regulatory Submissions and Advisory Committee Meetings Series: Preparing Your Organization for Success
  • Regulatory Submissions and Advisory Committee Meetings Series: Preparing Your Organization for Success
  • eCTD Easing the Transition Webinar
  • FDA Public Meeting Update Webinar
  • SPL Labeling Release 4.0: What You Need to Know, November 7, 2007
  • The Frictionless Supply Chain: From Collection to Submission
  • eCTD: Easing the Transition
  • The EU eCTD MAA Getting Started
  • Submission Management Webinar Series Part 2
  • The EU eCTD MAA Getting Started
  • Submission Management Webinar Series Part 1
  • eCTD Action Plan for Small Pharma and Biotechs
  • US eCTD: Getting Started
  • eCTD Capabilities: Tools That Ease the Transistion
  • FDA Part 15 Public Meeting
  • Submission Document Standards and Processes: Starting with the End in Mind
  • Data Conversion Scenarios: Practical Experience with CDISC SDTM
  • Issue Management Using ViewPoint®
  • The Top Five Risks of Converting to CDISC SDTM Standards and How to Avoid Them
  • Organizational Impacts of the FDA Electronic Labeling Initiative
  • Preparing for a CDISC SDTM Conversion Project
  • Submission Process Tracking and Resource Estimation
  • Elements of Enterprise Submission Process Management
  • Submission Crunch Time
  • Navigating the eSub Landscape: Process Improvement for Implementing Electronic Submissions
  • Part 1: Introduction to Structured Product Labeling (SPL)
  • Part2: Implementation Approaches to Structred Product Labeling (SPL)
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