ART-hero-image-1920
EU_Post-Marketing_Requirements_for_Cell_and_Gene_Therapy_Studies_Title_Card_d01

 

EU Post Marketing Requirements for Cell and Gene Therapy Studies​


Post-marketing requirements within the European submission process offer conditional approval more flexible than FDA. Rachel Smith, Portfolio Director for Veristat, discusses the three types of post-marketing requirements that can be requested by the EMA and draws upon the recently approved therapies – Tecartus, Zolgensma and Libmeldy, Skysona and Abecma– for real-world context.

Your browser does not support the audio tag.


Play another episode from our library

ART_logo_reversed_horizontal_stacked


Listen and subscribe on your favorite podcast player

  apple-podcast-badge EN_Google_Podcasts_Badge_1x spotify-podcast-badge-blk-grn-330x80 

  • Privacy Policy

© 2023 Veristat, Inc. All Rights Reserved.

Return to Top