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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Articles
NDMA: a recall trigger for the drug development industry
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.
Release of sterile medicinal products – looking at the focal points
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.
A novel cannabinoid formulation for glioblastoma treatment
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…
Developing a preventive vaccine regimen to tackle Ebola
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…
Expert view: Our air samplers are designed to perfectly match customer needs
A discussion between experts Roger Haas, Head of Environmental Monitoring Franchise at Merck KGaA, Darmstadt, Germany, and Ronny Zingre, CEO of MBV AG.
Expert view: Realising real-time TOC testing and Pharma 4.0 improvements in pharmaceutical grade water systems
This expert view from SUEZ discusses how total organic carbon (TOC) and conductivity monitoring are crucial aspects of purified water system quality and control.
Expert view: How robust is your fungal ID strategy?
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.
Manufacturing, Packaging & Logistics In-Depth Focus 2020
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.
Bioprocessing & Bioproduction In-Depth Focus 2020
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.
QA/QC & Analytical Techniques In-Depth Focus 2020
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.
Formulation, Development & Delivery In-Depth Focus 2020
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.
European Pharmaceutical Review Issue 4 2020
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…
Three tips to manufacture quality compliant PPE
Dr Stephane Gobron explores three different ways that manufacturers can use to bring their PPE up to regulatory standard.
Cannabinoid series: a CBD cocrystal for the treatment of PTSD
European Pharmaceutical Review spoke with Dr Andy Yates to discuss Artelo Bioscience’s new CBD and TMP cocrystal, with the potential to treat PTSD.
