The presentation “Which comes first: Regulatory Information Management (RIM) or ISO Identification of Medicinal Products (IDMP)?” was given by Deborah Cooper, Vice President Consulting at GENPACT Pharmalink, at LORENZ userBridge.15 in Vienna, Austria.
In her presentation, Deborah Cooper discussed the impact of the ISO IDMP Implementation Roadmap on RIM strategies and presented the GENPACT IDMP readiness assessment for customers.
The ISO IDMP Standard and Iterative Implementation Roadmap
Based on EU Commission Implementing Regulation No 520/2012 (articles 25 and 26), the EMA is in the process of implementing the five ISO standards for IDMP (ISO 11238, 11239, 11240, 11615 and 11616). This should simplify the exchange of information between regulatory authorities, enhancing the interoperability of systems at EU level and internationally. The European Commission, the European Union (EU) Network Data Board and the EU ISO IDMP Task Force have endorsed a phased implementation of the ISO IDMP standards.
LORENZ userBridge, our annual LORENZ community conference, is one of the most educational events in e-regulatory affairs globally, bringing together both industry and agency perspectives in one gathering.
Would you like to get a vivid impression of our conference? Watch the LORENZ userBridge Video!
One of the biggest changes to the electronic common technical document (eCTD) in the past few years was the introduction of the United States Food and Drug Administration’s (USFDA) newest module 1 specifications and corresponding technical files. The new specifications v2.3 and the XML Document Type Definition (DTD) v3.3 were developed to enhance USFDA’s ability to process eCTD submissions and enable additional submission types that were previously not accepted in eCTD format.
After a lengthy testing period, USFDA began accepting submissions using the new v2.3 specifications in June 2015 and has now received thousands of submissions using the new module 1. While uptake has been good, most submissions were applications being submitted to USFDA for the first time, starting from a clean slate with the new specifications.
Transitioning existing applications to the new module 1 adds complexity to eCTD publishing but should not be treated as roadblock. Here we will discuss preparing existing applications for the transition and ways to smooth the process for a successful transition.
The April releases of docuBridge, drugTrack, eValidator and docuBridge ONE are available!
Click here for selected highlights of the new versions of docuBridge and drugTrack:
What’s new in docuBridge 5.8?
What’s new in drugTrack 5.1.1?
docuBridge ONE now supports 8 different regions: AU, CA, CH, EU, GCC, TH, US, ZA!
Purchase docuBridge ONE in our Online Store.
Markus Pfahlert, Product Manager of LORENZ drugTrack, participated in the ISO IDMP Task Force Meeting in February and compiled this summary of the outcomes.
Representatives from EMA, NCA, industry, consultants and vendors participated in this meeting.
Referentials & Organisations
(click here to view the whole presentations: Referentials, Organisations)
Currently the Referentials Group is trying to create a common exchange process for distributing referentials lists. There are 2 different activity streams for each: 1) the gathering (or mapping of already existing data such as EVMPD) and 2) the distribution. For the latter, help from vendors will be needed on both the exchange process itself and for a User Acceptance Test (UAT) on building the exchange system.
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
Jared Lantzy, Manager Global Regulatory Agencies and Processes at LORENZ Life Sciences Group, compiled a short summary of current and future technology initiatives at FDA presented at the 2016 DIA RSIDM.
Brad Wintermute, the Deputy CIO and Director of the Office of Technology and Delivery at FDA, opened the 2016 DIA Regulatory Submissions, Information, and Document Management Forum (DIA RSIDM) on Monday, February 8, 2016 by outlining current and future technology initiatives at the agency. It is very refreshing to see agency leadership not only paying attention to electronic submissions programs but identifying these programs as priorities essential to FDA’s mission.