eCTD in Australia: key steps to start a successful submission

Duration: 60 minutes


Registration

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Why watch

Summary

In this webinar you'll learn how eCTD was introduced for Australia during the last few years and find out more on the current status of the introduction. Karl-Heinz Loebel (Pharmalex) will also give an overview of the Australian templates, their overall structure, and the standardized modules (M2-M5), as well as further specifics with a focus on module 1 and the envelope. 
After that Anna Kispál (Product Consultant at LORENZ) will demonstrate the Australian template in a live environment. She'll focus on the module 1 specifics in the envelope and will also demonstrate selected lifecycle operations in docuBridge. She'll also demonstrate how you can reuse submissions you've previously created for other regions such as the EU by copying the standardized M2 to M5 modules.

Key Learnings

  •  Know the structure of the Australian eCTD template
  •  Understand the administrative information in module 1 (envelope)
  •  Know how to create a lifecycle for your Australian submission and what to consider in it
  •  Know how to reuse available submission elements from existing (EU) submissions
speakers

A full hour of inspirational speaker(s)

Anna Kispál

Product Consultant, LORENZ Life Sciences Group   

Anna Kispál has several years of experience in software training. At LORENZ, as a member of the Education and Consulting team she performs docuBridge trainings for various customers globally and prepares the required training content accordingly. She provides consultancy to companies during and after LORENZ suite implementation projects.

 

Karl-Heinz Loebel

Director, Principal Consultant RegOps 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.