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.

RAPS is the world’s largest association for those involved in the regulation of healthcare and related products. These include pharmaceuticals, medical devices and biologics, as well as nutritional products.

This year, the workshops are preparing participants for submitting eCTDs to the FDA, with a strong focus on the new electronic requirements that were introduced in May 2018. As of that date, all commercial INDs and master files, as well as all NDAs, ANDAs and BLAs must be migrated to the new mandatory ICH eCTD format. In order to comply, organizations need a deep and detailed understanding of the interrelated processes for delivering and implementing the necessary operational changes. In addition, the workshops offer a brief overview of the differences between submissions in the U.S. and the rest of the world.

We believe that these workshops help participants noticeably improve their performance on complex eCTDs. We are pleased to be able to support RAPS in their endeavor to support and guide professionals in the regulatory affairs field, and look forward to supporting many more workshops in the future.

If you are interested in participating in the RAPS workshop on November 15 and 16 in San Diego, please click here.

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