title: Cell therapy clinical trials in Germany--Critical aspects of quality data content: Summary of meeting presentation.
abstract: 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.
authors.affiliation: Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, 63225 Langen, Germany. Electronic address: matthias.renner@pei.de.
authors.forename: Matthias
authors.initials: M
authors.lastname: Renner
mesh_terms: D064987:Cell- and Tissue-Based Therapy; D002986:Clinical Trials as Topic / Q000592:standards*; D005858:Germany; D006801:Humans
keywords: Advanced therapy medicinal products; Cell therapy; Clinical trials; Manufacturing; Quality; Regulatory research