From: 28 Jun 2022 | To: 28 Jun 2022 | Location: WEBINAR/ONLINE
Time: 8:30 - 9:30 am CEST
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 Life Sciences) 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.
Director, Principal Consultant RegOps Industry/Agency Liaisons, PharmaLex GmbH
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 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.