Thought Leadership
Journal Article
- January 31, 2023
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.
Blog & Article
- 30th January 2023
Video
Mark Lane | PharmaLex Expert
- January 18, 2023
Get to Know Mark A. Lane, PhD, VP of Development & Scientific Affairs
Video
Susan Мaue | PharmaLex Expert
- January 18, 2023
Get to know Susan Maue, PharmaLex Country Manager North America
Blog & Article
- 13th January 2023
Journal Article
- December 19, 2022
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.
Blog & Article
- 14th December 2022
Journal Article
- December 2, 2022
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.