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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.)
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.
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.
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.
Do you want to learn more about LORENZ Solutions @ Customers? In this video Giacomo Ridi of Menarini Ricerche S.p.A. talks about LORENZ Solutions at the Menarini Group and provides his insights on the work prior to using LORENZ solutions, the challenges in implementing the LORENZ solutions and the improvements achieved together with LORENZ.