eCTD v4.0: Field-testing the Implementation Guides

February 15, 2017 10:00–11:00 Eastern Time (US & Canada)

This webinar will provide an update on the state of eCTD v4.0 implementation from the tool vendor, industry, and agency standpoints. The results of a field-test will be presented along with the current challenges for implementation. Expected pilot testing and adoption timelines for regulatory authorities will also be discussed.

Specifically, topics addressed will be:
• Test results and lessons learned
• Challenges for stakeholders
• Transition from eCTD v3.2.2 to eCTD v4.0
• Agency scope and timeline for implementation
• Benefits of eCTD v4.0

Speaker - Jared Lantzy, PMP, is the Manager of Global Regulatory Agencies and Processes at LORENZ International LLC.

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