Alignment of reality with ICH quality systems theory is under way. Industry is developing, promoting and implementing global solutions through ISPE's new PQLI process, with the involvement of regional regulators. Conformia's new, more complex mock P2 could kindle more QbD. Genentech's approach to QbD described in detail. Quality systems seen as an option you can't refuse. Lessons from the device sector. Why Lilly switched to quality systems and how it benefited. How Abbott prepares for the future with management reviews. What Amgen did to correct its CAPA process - and save millions of dollars along the way
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
The Council of the EU has made several key amendments to the legislative reform package, which it will now negotiate with the European Parliament.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
