FDA GFI, CGMP for Animal Cells, Tissues, and Cell- and Tissue-Based Products, 10/22 Anastasija Eschricht2023-07-24T12:50:36+00:00July 24th, 2023|
EMA Questions and Answers: EU GMP Guide Part IV, ATMPs, use of out-of-specification batches, 04/19 Anastasija Eschricht2023-06-14T07:33:59+00:00June 14th, 2023|
EMA Questions and Answers: EU GMP Guide Part IV, ATMPs, Exemption from batch controls imported ATMPs, 07/19 Anastasija Eschricht2023-06-09T07:19:05+00:00March 21st, 2023|
FDA GFI, Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial, 11/22 Anastasija Eschricht2023-02-08T10:21:45+00:00February 8th, 2023|
EMA Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources, DRAFT, 09/22 Beatrice Burtsov2023-06-09T07:22:46+00:00November 16th, 2022|
EMA Questions and Answers: GMP for manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs, 02/21 Beatrice Burtsov2022-11-09T09:15:55+00:00November 9th, 2022|
