US NDA versus EU MAA eCTDs – Exploiting the Synergies and Mastering the Differences

Title: US NDA versus EU MAA eCTDs – Exploiting the Synergies and Mastering the Differences

Date:  March 23, 2021

Time: 3PM CET

Duration:  1 hour

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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

Speakers: 

Adair Turner

Principle, Consultant, Director RegOps, PharmaLex

Karl-Heinz Loebel

Director, Principal Consultant RegOps Industry/Agency Liaisons, PharmaLex

Melissa Rapp

Manager, RegOps, PharmaLex

Parul Patel

Senior Product Consultant, LORENZ Life Sciences Group

Jan Wermusch

Product Manager, LORENZ Life Sciences Group

Akira Yamaguchi

CTO, LORENZ Life Sciences Group