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The Genomic Complex by Derra, Abdoul Hamid

The Genomic Complex

by Abdoul Hamid Derra
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Book cover type: Paperback
  • ISBN13: 9783330511231
  • Binding: Paperback
  • Subject: N/A
  • Publisher: Our Knowledge Publishing
  • Publisher Imprint: Our Knowledge Publishing
  • Publication Date:
  • Pages: 540
  • Original Price: GBP 100.83
  • Language: English
  • Edition: N/A
  • Item Weight: 713 grams
  • BISAC Subject(s): Clinical Medicine

The term "ATMs" is understood to refer to both advanced therapy medicinal products that have been granted a marketing authorization and advanced therapy medicinal products that are the subject of clinical trials or are used as a reference in a clinical trial (investigational advanced therapy medicinal product). This guide specifies the GMP requirements that must govern the manufacture of ATMPs that have been granted a marketing authorization and ATMPs used in a clinical trial context. This guide does not apply to medicinal products other than ATMPs. However, the detailed guidelines referred to in the second paragraph of Article 47 of Directive 2001/83/c4 and Article 63(1) of Regulation (EU) No 536/2014 do not apply to ATMPs unless specifically referred to in these guidelines. If specific provisions only concern advanced therapy medicinal products that have been granted a marketing authorization, the term used is "authorized ATMPs".

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