Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
The Genomic Complex

The Genomic Complex

Derra, Abdoul Hamid

Paperback

Medical Reference

ISBN10: 3330511230
ISBN13: 9783330511231
Publisher: Our Knowledge Publishing
Published: Apr 15 2025
Pages: 540
Weight: 1.57
Height: 1.20 Width: 6.00 Depth: 9.00
Language: English
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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