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April 28, 2014
05:48 EDTPSTIPluristem's manufacturing facility approved by EU auditors for Phase III trials
Pluristem Therapeutics announced that its new manufacturing facility has received the European Union's Qualified Person Declaration. With this declaration, Pluristem is now approved to use cell therapies manufactured at its state-of-the-art facility located in Haifa, Israel, in all phases of its clinical trials conducted in the European Union, including Phase I, Phase II and Phase III. The Qualified Person inspection was conducted in line with the European Union's Good Manufacturing Practice, or GMP, legislation, directives and guidelines. The audit focused on the design, construction and validation of Pluristem's new facility, equipment, utilities, and quality management systems. Pluristem's manufacturing and cell expansion operations were deemed compliant with EU GMP requirements.
News For PSTI From The Last 14 Days
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May 25, 2015
18:48 EDTPSTIPluristem issues shareholder letter, sees submitting PLX-R18 protocol late 2015
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May 18, 2015
09:25 EDTPSTIOn The Fly: Pre-market Movers
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05:13 EDTPSTIPluristem PLX Cells selected for EMA adaptive pathways pilot project
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May 13, 2015
05:43 EDTPSTIPluristem announces PMDA quality approval for PLX-PAD cells for use in trial
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