Journal Articles

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.
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.
Journal Article
Like the previous workshops, this event was characterized by a mix of presentations on specific Annex 1 topics combined with interactive workshops, whereby participants had the opportunity to ask the panel of experts about the presented subjects. Above all, it provided the opportunity to discuss the participant’s interpretation, challenges and possible solutions with peers from the industry. Based on the number of questions asked of the panel, this turned out to be a very successful workshop with a high level of interaction between participants and presenters and during round-table discussions.
Journal Article
The upheaval wrought by the COVID-19 pandemic has had a silver lining for researchers and participants in decentralized clinical trials (DCTs), giving rise to a transformational philosophy more attuned to the needs of the patient.
Journal Article
The ICH-Q2 has stated that the objective of validation of an analytical procedure is to demonstrate that it is suitable for its intended purpose, yet it – as well as the ICH-Q14 – fails to clearly define the actual aim of analytical procedure, leading to misunderstanding and confusion. Bruno Boulanger, Ph.D., Global Head Statistics and Data Science at PharmaLex, discusses how Bayesian statistics and interpretation bridge the gaps in the guidelines.
Journal Article
With both the cost and time to bring a drug to market ballooning, the importance of an integrated product development (IPD) strategy is gaining traction. This multidisciplinary approach to drug development brings key stakeholders together, breaking down barriers to an e!cient and cost-e”ective path to market. But while more organisations are adopting an IPD strategy, a recent industry survey found most aren’t doing so early enough. Frédéric Pailloux, Senior Director, Head of Integrated Product Development and Consulting at PharmaLex examines the IPD journey.
Journal Article
After nearly six months of war, life for patients in Ukraine continues to get harder. The World Health Organization (WHO) has reported that people’s health has been imperiled by difficulty in accessing emergency care and essential medicines. Dr. Hans Henri P. Kluge, WHO Regional Director for Europe, noted that there had been more than 260 verified attacks on healthcare in Ukraine by early June, resulting in some health facilities being destroyed and others struggling to cope with people seeking care from trauma and injuries.
Journal Article
Companies must safeguard their mature portfolios while continuously innovating and developing new products. But in-house resources are stretched and often lack the broader knowledge needed to ensure best practices for ongoing maintenance activities. As a result, traditional models of outsourcing – the low-cost, “lift and shift” approach of the past – are giving way to a more nuanced, strategic approach. One that leverages external expertise globally and delivers more efficient methods for supporting the product lifecycle. Dr. Constanze Burkhardt, Vice President, Head of Program Management at Pharmalex, explores why outsourcing the mature portfolio has become an industry priority.
Journal Article
Pages 12-13. Annex 1 “Manufacture of Sterile Medicinal Products” was first published in 1971 and forms part of EudraLex Volume 41 that interprets the basic principles of GMP as detailed in European Directive 2003/94/ EEC.2 Annex 1 provides guidance on the minimum controls that are required to protect sterile medicinal products during manufacturing.
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