EMA Questions and Answers: EU GMP Guide Part IV, principles of GMP for manufacturing of starting materials of biological origin used to transfer genetic material for the manufacturing of ATMPs, 04/21 Anastasija Eschricht2023-02-24T09:22:53+00:00February 24th, 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 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|
EU Guidance Inspection of Tissue & Cell procurement and Tissue establishments, 04/15 Beatrice Burtsov2022-04-05T13:27:16+00:00April 5th, 2022|
FDA GFI, Regulatory Considerations for HCT/P Minimal Manipulation and Homologous Use, 12/17 2021-09-22T13:46:44+00:00January 17th, 2020|
FDA GFI, Current Good Tissue Practice for Manufacturers of HCT/Ps, 12/11 2021-09-22T12:40:37+00:00January 17th, 2020|
