Industry is currently seeing rapid changes and improvements to existing eCTD formats, requirements and suggested uses from FDA. These and other changes affect Regulatory Operations as a whole. Here at LexisNexis Reed Tech, we want to be sure that our customers are not only up-to-date with, but understand, these new developments. To support this knowledge share, our in-house team of eCTD experts are presented a webinar on Tuesday, July 30, 2024. This webinar provides a comprehensive overview of the upcoming eCTD v4.0 update, a significant shift from the current v3.2.2 standard.

Key Takeaways:

• The key changes introduced in eCTD v4.0, including:
  • A single, global XML message format for regulatory submissions
  • A structure that better reflects the submission process
  • Enhanced life-cycle management capabilities
  • Bi-directional communication between submitters and regulatory authorities
• The benefits of adopting eCTD v4.0, such as:
  • Streamlined submission process
  • Improved data quality and reuse
  • Enhanced collaboration between sponsors and regulators
• The timeline for implementation and how to prepare for the transition

Watch this webinar to gain insights into eCTD v4.0 and ensure your organization is prepared for the future of regulatory submissions. WATCH NOW.

Reed Tech is the provider of best-in-class information-based solutions and services to meet the needs of the life sciences industry, government agencies, and the intellectual property market. Our customers are located throughout the world and include a wide range of medical device manufacturers and pharmaceutical companies, the U.S. government, numerous Patent Authorities, and IP-driven companies and law firms. The corporate mission is to advance humanity by delivering better outcomes to the innovation community.