A Play Book for getting C-level attention to quality could be to wait for the fiasco. But speakers at the recent ISPE Washington conference had some better ideas. They talked about creating an ICH Q10 quality system that brings senior managers into the loop. They explored the importance of establishing a 'quality culture,' which starts with senior management. Don't delegate the quality system design to Quality, they said. And make sure there is a strong and responsive management review system in place. They also went over some of the common objections to investing in quality - and their favorite rebuttals. They explored the use of 'product quality stewards' and described a difficult investigation into mysterious glass breakages.
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
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.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
England’s health technology assessment institute explains how its sandbox environment is helping to test new evaluation methods for drugs or indications with which it does not have experience, such as metabolic dysfunction-associated steatohepatitis.
The European Medicines Agency, like its counterpart in the US, is increasingly focusing on the use of alternatives to animal testing.
Industry is concerned that Prasad may make regulatory flexibility tougher to obtain for cell and gene therapy, while vaccine and public health advocates are angry about Prasad’s criticisms of US COVID-19 policies.
