VISTART – What is this initiative?

The initiative was launched in 2005 to further support improvements in vigilance and inspection in the fields of blood, tissues and cells, VISTART is co-funded by the Public Health Programme and is led jointly by the two authorities in Italy that are responsible for the oversight of these fields: the Italian National Transplant Centre and the Italian National Blood Centre. Thirteen Member States and Norway are associated partners and many others are also collaborating in this important initiative, the first action to bring together the worlds of blood transfusion and tissues and cells.

One working group will propose regulatory principles for short and long term follow up in patients treated with tissues, cells and blood prepared with novel processing methods. Evaluation of safety and efficacy of innovative newly developed tissues, cells and blood products are a major concern and the specific working group (WP5 Part B). Based on the commonly agreed concept about the correlation between high risk level of a new cell based product and the extent of clinical follow up plan of the recipients, the WP5B group further developed several principles and general indications for the Competent Authority (CA) that has to assess the quality/safety profile of the novelty also taking into consideration the clinical outcome. The deliverable is in its pre final version and it is listing general indications for the assessor of the clinical follow up plan integral to the Preparation Process Dossier (PPD).

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Sheli Kuperman