Thought Leadership

Journal Article
Trial master files were long treated as an archive repository for all documents related to a clinical trial. That approach doesn’t properly reflect the evolving story of a study, which will go through a variety of changes and milestones throughout the product lifecycle and across different study regions.
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Mark Lane | PharmaLex Expert

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Susan Мaue | PharmaLex Expert

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Journal Article
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a long-awaited draft revision of its Q9 guidance on quality risk management (QRM) for public consultation in December 2021  (1). First published in 2005, ICH Q9 has been instrumental in highlighting the importance of QRM in both the small- and large-molecule pharmaceutical industries.
Journal Article
Manufacturers of medical devices must put in place a wide range of processes and documentation to meet post-market surveillance requirements. While this means more work, Belinda Dowsett of PharmaLex* explains that these requirements do give manufacturers better insight into the performance of their devices.
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