The aim of this webinar is to present and analyze the new challenges for Pharmaceutical Industry that arise with the upcoming eCTD requirements in China. It will provide an overview on the Chinese technical requirements and interpretation of ICH eCTD rules, Module 1 and envelope particulars, complications resulting from overall language and translation needs, but also consequences for submission planning, coordination and the inclusion of Chinese eCTD publishing into an integrated global publishing environment.
The second half of this webinar will feature a live demonstration of compiling submissions based on the CN [specification/template] using Lorenz docuBridge software. In particular, we will look at compiling Modules 1, 3 and 5 as well as lifecycle operations while focusing on the main differences to other eCTDs such as EU and US.
Director, Principal Consultant Regulatory Operations Industry/Agency Liaisons, PharmaLex
Karl-Heinz Loebel has spent the last 15 years in Regulatory Affairs, focusing on electronic submission, data management and systems implementation. He has been responsible for PharmaLex eCTD submissions in traditional ICH regions ever since and is now also coordinating the extension of the company’s publishing capabilities to the requirements of the regions that joint the eCTD community most recently, like China and EAEU.
Product Consultant, Lorenz
Kristina Roberson has 8 years of software training experience and conducts docuBridge trainings for companies around the world as a member of the Lorenz Education and Consulting team. With the recent addition of the EAEU-specification China to the docuBridge suite, she also provided specialized user pilot training for customers interested in using this feature.
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