{"product_id":"9783330511231","title":"The Genomic Complex : Manufacturing Standards for Innovative Therapy Medicines Derived from Biological Material for Human Use.DE","description":"\u003cp\u003eThe 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\". Abdoul Hamid Derra - Information systems engineer, entrepreneur, researcher, strategic studies developer, education advisor, maternal-child health, nutritionist.\u003c\/p\u003e","brand":"Our Knowledge Publishing","offers":[{"title":"Default Title","offer_id":48865678885099,"sku":"00000_00000_00000_00000","price":241.71,"currency_code":"SGD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0758\/4484\/5803\/files\/9783330511231-1.jpg?v=1781719929","url":"https:\/\/kinokuniya.com.sg\/products\/9783330511231","provider":"Books Kinokuniya Singapore","version":"1.0","type":"link"}