Improving quality in investigator‑led clinical trials
Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
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Laura Trotta explains why risk-based quality management is the best strategy to ensure data integrity of information from investigator-led clinical trials.
Product recalls due to contamination issues can be extremely costly for companies, in addition to the associated health implications. In this article, Marc Baiget Francesch explores the potential risks associated with N-nitrosodimethylamine (NDMA) contamination, why is it such a frequent contaminant and how to detect and eliminate the risks.
There are numerous risks and regulatory requirements that must be considered to ensure appropriate contamination control of sterile medicinal products. Tim Sandle discusses the complexities of sterility assurance and provides guidance for manufacturers to ensure that appropriate risk management processes are in place.
Earlier this year, MGC Pharmaceuticals, in collaboration with the Slovenian National Institute of Biology (NIB) and the Neurosurgery Department at the University Medical Centre in Ljubljana, Slovenia, announced successful research results for their novel cannabinoid formulation, which has been developed for the treatment of glioblastoma. This article highlights the key…
Earlier this year, Johnson & Johnson announced the first major regulatory approval of a vaccine developed by Janssen for the prevention of Ebola. Nikki Withers spoke with the Global Head of Vaccines, Johan Van Hoof, to discover what technologies were used and how they are now being leveraged to develop…
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
This expert view from SUEZ discusses how total organic carbon (TOC) and conductivity monitoring are crucial aspects of purified water system quality and control.
This expert view from Charles River explores the different methods of fungal identification, allowing you to proactively address issues before they occur and provide information for successful remediation.
The articles in this in-depth focus detail how Novartis prepared and adjusted their manufacturing and supply chain to minimise the impact of the COVID-19 pandemic and an exploration of what digitally enabled inventory processes can do to enhance FMD compliance.
In this in-depth focus are articles on what manufacturing challenges must be overcome for regenerative medicine to reach its potential and how automation and digitalisation ensure efficient bioprocessing.
Included in this in-depth focus is a discussion on how to detect and eliminate NDMA impurities in medicines and an article exploring the complexities of sterility assurance, providing manufacturers with guidance.
In this in-depth focus find out about the development of a vaccine regimen to tackle Ebola and how a novel cannabinoid formulation has been developed to treat glioblastoma.
Within this issue find articles on the complexities of sterility assurance, how to detect and eliminate the risk of NDMA contamination and the findings from a study involving a novel formulation of cannabinoids that has been developed to treat glioblastoma. Also included are articles on the opportunities blockchain provides for…
Dr Stephane Gobron explores three different ways that manufacturers can use to bring their PPE up to regulatory standard.
European Pharmaceutical Review spoke with Dr Andy Yates to discuss Artelo Bioscience’s new CBD and TMP cocrystal, with the potential to treat PTSD.