webinar took place on May 16th 2023.
When developing ATMP’s questions are often raised regarding the acceptability of the raw materials used in production. The choices made will impact your entire process from IMPD to marketing authorisation application stage. A rule of thumb is that quality is key for ATMP development and that regulation authorities adhere to the best quality standards.
- Joris De Wolf (eyetec) will set the scene and cover the guidelines and directives.
- Sam Vanleene (anicells) and Louise De la Mane (UZ Ghent) will talk about their own experience as QP in the translation of the guidelines into a capable process.
- David Craeye (Fishway) and Marlin Frechette (FUJIFILM Irvine Scientific) will share their experiences and insights from the viewpoint of user and manufacturer of raw materials.