Event / Webinar

eCTD in China

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.

On-Demand 60 minutes Your Desk!

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Speakers

Karl-Heinz Loebel

Director, Principal Consultant Regulatory Operations Industry/Agency Liaisons, PharmaLex

Kristina Roberson

Product Consultant, LORENZ LIfe Sciences Group

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.

Key learning objectives:

  • 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
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