Author Archives: llsmarketing

LORENZ docuBridge, eValidator and Automator implementation progressing at US FDA – Preparing to migrate 1.3 million eCTD sequences

In response to questions about our ongoing implementation project at the US FDA, we would like to share a short update with you.

In our previous blogpost, we announced the need to migrate approximately 1.3 million legacy eCTD sequences into our docuBridge solution and make them available to US FDA reviewers.

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International Trends in Drug Registration and Evaluation [Part 3: ISO IDMP and the MPID]

Summary of part 1 and 2:

In our last blog posts of the series you were informed about eCTD v3.2.2 and eCTD v4.0. The articles resolved around the advantages of eCTD v3.2.2 over paper or non-eCTD electronic submissions and the improvements from eCTD v4.0 over eCTD v3.2.2. If you have not read it, you will find the first article here and the second article here.

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RAPS – Intermediate Course for Regulatory Submissions in eCTD Format

RAPS has once again chosen LORENZ to support their intermediate-level training workshops. Here, our LORENZ docuBridge solution is being used to illustrate the eCTD concept in detail, with discussions led by members of LORENZ and Mentara Inc.. The collaboration on RAPS workshops has been running since 2012.

Two of the three planned workshops in 2018 have already been completed; the first in San Diego, CA during April and the second in July in Rockville, MD. San Diego will also host the third training this coming November.

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Visualizing STF Content in a Browser Using the ICH Stylesheet

Currently we are receiving many support questions regarding an issue that arises when displaying STF study reports in a browser using the new stylesheet version 2-3. We would like to explain the background and why we need to wait until ICH issues another official stylesheet to correct this.

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