From: 9 Jul 2020 | To: 9 Jul 2020 | Location: WEBINAR
Time: 15:00 - 16:00 (CEST) / 09:00 - 10:00 (EDT)
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 of 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 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.
- eCTD submission requirements for China
- CN eCTDs in a global publishing environment
- Compilation and Submission Life Cycle
- Main differences to other eCTD formats such as EU and US
Kristina Roberson, Product Consultant LORENZ Life Sciences Group
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. She has also provided specialized user pilot training for customers on new specifications.
Karl-Heinz Loebel, Director/Principle Consultant 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.