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.
With the release of version 3.3 of its eCTD Module 1 specifications, the US FDA has enabled industry to streamline eSubmission processes. With these new features come added complexity that must be mastered to take full advantage of upgraded functionality. Join us at the inaugural LORENZlink RIM conference on April 4 – 5, 2016 in Scottsdale, AZ, for a detailed discussion of changes and lessons learned to ensure a successful transition to the new Module 1. You will learn about:
- FDA experience with the new Module 1 including common validation errors
- Considerations and best practices for transition
- When and why grouped submissions make sense
- Tips for preparing and submitting Promotional Labeling and Advertising in eCTD format
- Updates on US FDA’s upcoming eCTD mandate
The presentation “eSubmissions in Australia” was given by Kent Briggs, Lead Senior Consultant at LORENZ Life Sciences Group, at LORENZ userBridge.14 in Milan, Italy.
In September, I presented the status of eSubmissions in Australia on behalf of the TGA. Since then, the TGA has been busy ensuring a quick and successful implementation of eCTD and setting the foundation for electronic review across all formats.
From the beginning, the TGA “pilot” was kept open allowing anyone to take part that expressed interest. As a result, the first eCTD applications began arriving in October and the first lifecycle sequences in the early parts of 2015.
The presentation “Preparing for First eCTD in ASEAN” was given by Teerapong Cheepchol (Jack), Deputy Managing Director of Factorytalk Co., Ltd. in Bangkok, Thailand, at LORENZ userBridge.14 in Milan, Italy.
Mr. Cheepchol (or Jack as he is known here at LORENZ), who also presented at userBridge.13 last year in Budapest, Hungary, used the userBridge.14 conference to present an update on what was happening in Thailand with regards to the eCTD and electronic submission in general. What might not be known by most people is that ASEAN uses what is called the ACTD (ASEAN CTD) structure or format, which differs in structure when compared to the CTD but still contains more or less the same information as the CTD. Continue reading