Tag Archives: eCTD

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.

Continue reading

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.

Continue reading

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.

Continue reading

International Trends in Drug Registration and Evaluation [Part 2: eCTD v4.0]

Our last blog post on this topic covered eCTD v3.2.2 and its advantages over paper or non-eCTD electronic submissions. The main selling points of v3.2.2 are its reliable presentation of information to reviewers, the level of flexibility for national authorities, the metadata for automated processing, the life cycle information on documents, and the reuse of information.

Introduction
In this second part of our series about international trends in drug registration we dive into the improvements from eCTD v4.0 over eCTD v3.2.2.

Continue reading

UPDATE: Current State of US FDA’s Electronic Common Technical Document (eCTD) Validation and Review Software Procurement and Implementation

We would like to provide our customers and the industry with an update on the status of LORENZ’ implementation of LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

(Please click here to read our previous blogpost including a timeline of events from 1 July 2016 – 30 May 2017.)

Continue reading

International Trends in Drug Registration and Evaluation [Part 1: eCTD v3.2.2]

Today Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ, starts with a series of articles talking about international trends in Drug Registration and Evaluation. He will provide an update on some selected topics in electronic submissions and some insight into how LORENZ will deal with these evolving regulatory requirements.

Introduction
Regulatory authorities around the world continue to adopt internationally recognized data standards in an effort to improve the efficiency of their work environments and processes. The most commonly discussed data standards are the Electronic Common Technical Document (eCTD); International Organization for Standardization (ISO) Identification of Medicinal Products (IDMP); Health Level 7 (HL7) Structured Product Labeling (SPL)-based standards for the transmission of product data, including IDMP; and Clinical Data Interchange Standards Consortium (CDISC)-based standards for both clinical and non-clinical study data.

Continue reading

Current State of US FDA’s Electronic Common Technical Document (eCTD) Validation and Review Software Procurement and Implementation

We at LORENZ have been receiving an increasing number of emails and phone calls from our customers and partners concerning the current state of the project implementing LORENZ docuBridge, eValidator, and Automator at the U.S. Food and Drug Administration (FDA).

In order to clarify the chain of events and alleviate any concerns, we are outlining below a timeline of events we hope will be helpful.

Continue reading