LORENZ Solutions @ Menarini Group

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.

lorenz-solutions-at-menarini-group

Which comes first: Regulatory Information Management (RIM) or ISO Identification of Medicinal Products (IDMP)?

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.

Continue reading

Join us at LORENZ userBridge.16 in Hamburg, Germany!

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!

Continue reading

USFDA eCTD Module 1 v2.3: Considerations for Transition

Introduction

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.

Continue reading