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Get insights from different stakeholders on specific ATMP topics.

Digitalization: Is it Worth It?

As with other drug molecules, ATMP’s have to comply to the Good Manufacturing Practice (GMP) guidelines, which require the meticulous assessment of both quality and consistency of the end product. This needs a careful monitoring of the entire manufacturing process, which is both a challenge and an opportunity for the ATMP field. Investing in efficient, innovative, reliable, automated, digitally monitored processes, will position ATMP as a frontrunner within the pharmaceutical sector, attracting additional funding and making way for improvements in other product areas. Yet, contrary to what one might expect, developers today are often not embracing automation or even digital transformation. A quick survey of developers indicates 3 main hurdles with regard to digitalized monitoring and record keeping. In this article, we take a closer look.

ATMP: Belgian legislation at a glance

Marc Martens elaborates on an important milestone set in the Belgian Advanced Therapy Medicinal Products (“ATMP”) legislation. On October 20th 2018, a modification of the law of December 19th 2008, regarding the collection and use of human body material for the purpose of human therapeutic applications or scientific research, was published. This modification enables progress in the development of new, innovative therapies based upon the handling of human cells and tissues for the production of medicines.