Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union-Reference-Cited by-同舟云学术

Call for More Effective Regulation of Clinical Trials with Advanced Therapy Medicinal Products Consisting of or Containing Genetically Modified Organisms in the European Union

Published:2021-10-01 Issue:19-20 Volume:32 Page:997-1003
ISSN:1043-0342
Container-title:Human Gene Therapy
language:en
Short-container-title:Human Gene Therapy

Author:

,Beattie Stuart¹^ORCID,Hubert Annie,Morrell Jill,Cook Jacquelyn Awigena,Werner Michael,Ginty Patrick,Butler Simon,Dahy Andeleeb,Coutinho Vicki,Roberts Neil,Rabbie Daniel,Gaido Marcia,Huh Seoan,Oliva Lauren,Georgieva Violeta,Lambot Nathalie,Reimer Tatiana,de Goeij Ine,Romanetto Julien,Acha Virginia,Tellner Par, ,

Affiliation:

1. Biogen, Gene Therapy Regulatory Chemistry Manufacturing and Controls, Biogen, Innovation House, 70 Norden Road, Maidenhead, SL6 4AY, Berkshire, England, UK.

Publisher

Mary Ann Liebert Inc

Subject

Genetics,Molecular Biology,Molecular Medicine

Link

https://www.liebertpub.com/doi/pdf/10.1089/hum.2021.058

Reference3 articles.

1. The Genetically Modified Organism Medicinal Framework in Europe, United States, and Japan: Underlying Scientific Principles and Considerations Toward the Development of Gene Therapy and Genetically Modified Cell-Based Products

2. Gene editing and CRISPR in the clinic: current and future perspectives

3. Is it time to reform oversight of clinical gene therapy in the EU ?

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