Lorenz Events
US NDA versus EU MAA eCTDs – Exploiting the Synergies and Mastering the Differences
From: 23 Mar 2021 | To: 23 Mar 2021 | Location: WEBINAR/ONLINE
Time: 11AM EST / 8AM PST / 5PM CET
Register hereAbout the webinar
Join us for a new webinar hosted by experts from PharmaLex and LORENZ Life Sciences Group on how to navigate the individual EU and US regional requirements while building on synergies on both sides of the Atlantic. Registration is free of charge. During the presentation, you will also be able to pose questions to our experts.
Applying for first-time drug authorizations in the US and Europe is one of the most challenging tasks in regulatory operations. It isn't just the sheer scale of the applications, which can easily reach several hundred thousand pages. There are also some differences, both technical and content related, in what agencies on the two sides of the Atlantic require.
If you intend cover both markets, either simultaneously or one after the other, efficient planning and preparation of your submission is crucial. To fully exploit synergies, you'll need detailed knowledge about which eCTD documents, and potentially even whole sections, can be re-used. It also helps to understand exactly how LORENZ docuBridge can assist you in applying the technical twists and tweaks required for each region.
Key learnings
- Differences between US and EU eCTDs
- Submission compilation planning and tracking for simultaneous application in different regions
- Understanding the docuBridge features supporting simultaneous submissions
About the presenters
Parul Patel
Senior Product Consultant, LORENZ Life Science Group
Parul Patel joined LORENZ in December 2016 as a Regulatory Solutions Engineer for LORENZ docuBridge, performing demos. Since then, she has evolved into Senior Product Consultant role for the NA market and project managing industry workshops. She performs product trainings and prepares training materials for various customers globally. In addition to representing LORENZ at RAPS workshops since 2016, she lead the training effort for a new regional regulatory agency client, including training content development; session schedules as well as working as the principal trainer and overall educational service delivery activities. Parul has worked in the Regulatory Affairs field since 2002 and holds a B.S. in Industrial Engineering from New Jersey Institute of Technology, New Jersey, USA.
Karl-Heinz Loebel
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.