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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 EDT / 8AM PDT / 4PM CET

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About 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. Any questions for our experts will be collected throughout the session and answered at the end of the presentation.

Applying for first-time drug authorizations in the US and Europe is a challenging task 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 to cover both markets, either simultaneously or one after the other, efficient planning and preparation of your submission is crucial. To fully exploit synergies, you will need detailed knowledge about which eCTD documents, and potentially even whole sections, can be re-used. The good news is that 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 led the training effort for a new regional regulatory agency client, including training content development and session scheduling, as well as working as the principal trainer in 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 have most recently joined the eCTD community, such as China and EAEU. Today he will share his experience with global submission projects that aim for simultaneous initial eCTD applications in Europe and the US.

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