Cell therapy clinical trials in Germany – Critical aspects of quality data content. Issue 5 (September 2015)

• Record Type: Journal Article
• Authors: Renner, Matthias
• Is Part Of: Biologicals. Volume 43:Issue 5(2015:Sep.)
• Page Start: 429
• Page End: 432
• Publication Date: 2015-09
• Subjects: Biological products -- Standards -- Periodicals; Biological Products -- Periodicals; Biological Products -- standards -- Periodicals; Produits biologiques -- Normes -- Périodiques; Biological products -- Standards; Periodicals; 615.37
• DOI: 10.1016/j.biologicals.2015.05.001
• Languages: English
• ISSNs: 1045-1056

Abstract

<abstract xml:lang="en" abstract-type="author" id="abs0010"> <title id="sectitle0010">Abstract</title> <sec> <p id="abspara0010">This article is summarizing a presentation given by the author at the International Alliance for Biological Standardization and Japan Science and Technology Agency (IABS-JST) Joint Workshop on "Challenges towards sound scientific regulation of cell therapy products" held at the Kyoto International Conference Center, Kyoto Japan on March 7–8, 2014. The main topics of the presentation were to give a short overview about the regulatory approval process for clinical trials in Germany and to summarize important manufacturing aspects of cell based medicinal products (CBMPs) which are intended to be studied in clinical trials in Germany.</p> </sec> </abstract>