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Showing results for tags 'Pharma / Life sciences'.
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News ArticleA French court has fined one of the country’s biggest pharmaceutical firms €2.7m (£2.3m) after finding it guilty of deception and manslaughter over a pill linked to the deaths of up to 2,000 people. In one of the biggest medical scandals in France, the privately owned laboratory Servier was accused of covering up the potentially fatal side-effects of the widely prescribed drug Mediator. The former executive Jean-Philippe Seta was sentenced to a suspended jail sentence of four years. The French medicines agency, accused of failing to act quickly enough on warnings about the drug, was fined €303,000. The amphetamine derivative was licensed as a diabetes treatment, but was widely prescribed as an appetite suppressant to help people lose weight. Its active chemical substance is known as Benfluorex. As many as 5 million people took the drug between 1976 and November 2009 when it was withdrawn in France, long after it was banned in Spain and Italy. It was never authorised in the UK or US. The French health minister estimated it had caused heart-valve damage killing at least 500 people, but other studies suggest the death toll may be nearer to 2,000. Thousands more have been left with debilitating cardiovascular problems. Servier has paid out millions in compensation. “Despite knowing of the risks incurred for many years, … they [Servier] never took the necessary measures and thus were guilty of deceit,” said the president of the criminal court, Sylvie Daunis. Read full story Source: The Guardian, 29 March 2021
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News ArticleHospitals across Europe, including Britain, as well as the Middle East and Africa are scrambling to replace millions of pieces of equipment used to treat patients, as fears grow that they could cause infections after a company was discovered to have falsified sterilisation records for more than a decade. The Independent has learned the problem affects more than 230 different types of infusion lines, connectors and associated kit, along with six infusion pumps used to deliver medicine and fluids into patients’ veins. Medical devices company Becton Dickinson, or BD, has issued a recall of six of its Alaris infusion pumps as well as related tubing and kit after an investigation found a company it uses was intentionally falsifying sterilisation records, meaning BD could not be certain the tubing and pumps were free from contamination. Hospitals across the UK have been given until the end of this month to stop using the pumps and quarantine any of the affected equipment. Any NHS trusts struggling with a lack of supply have been told to seek “mutual aid” from neighbouring trusts. Public Health England told The Independent it had not identified any large scale infections linked to the IV lines but said it could not rule out smaller isolated infections. Read full story Source: The Independent, 22 March 2021
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Content ArticleA recent survey of over 1,700 patient groups around the world has revealed the true toll the COVID-19 pandemic has had on patient communities, with many individuals feeling more vulnerable, confused and uncertain about the consistency and continuity of their care. Now, more than ever, the life sciences industry has a responsibility to listen to the unique and changing needs of patients. They must continue to work with patient organisations on their vital work to safeguard continued access to treatment and to understand their need for holistic support ‘beyond the pill’. Dr Berkeley Phillips, Country Medical Director of Pfizer UK, explains in this article how Pfizer continues to partner with patient organisations across a broad spectrum of conditions from cancer to rare diseases, ensuring patients feel equipped, informed and empowered despite the uncertainty.
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Content ArticleBioPhorum has developed a risk-based deviation management system (DMS). 13 member companies have implemented this approach, and summary data from these companies shows improved quality performance plus an average time saving of 22,200 work hours per site per year, which is equivalent to a $888k cost saving. An effective deviation management process is one that identifies and removes risk from processes using root cause analysis (RCA) principles and a corrective and preventive action (CAPA) programme. The current model used by many biopharmaceutical companies considers all deviations or events are equal and require a 30-day closure, known as the ‘30-day rule’1. Treating all events as equal and following the ‘30-day rule’ drives an inefficient process and wasteful behaviours. This guide outlines the work of the BioPhorum DMS Workstream in defining and creating a simplified and effective risk-based deviation management system with advanced RCA methodologies, and a track-and-trending process of low-risk events. It includes everything required to build a risk-based approach to DMS, including the business case for change, the new process, risk-based tools, and a detailed sharing of post-implementation benefit.
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Content ArticleA conversation with John Wilkes (AstraZeneca), Clifford Berry (Takeda), Amy D. Wilson, Ph.D. (Biogen), and Jim Morris (NSF Health Sciences). This article is the first part of a two-part roundtable Q&A focused on human performance in pharmaceutical operations. Part 1 discusses key drivers for human performance improvement, compares lean manufacturing and human performance programmes, and provides perspectives on human performance in the context of the rapid scale-up and production of COVID-19 therapeutics and vaccines. Part 2 reviews human performance in the context of company investigation and CAPA programmes.
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Event
Veracuity: Innovative approaches to drug safety
Sam posted an event in Community Calendar
Veracuity was conceived out of a recognition that the practice of pharmacovigilance is performed suboptimally. That is because it relies entirely on a voluntary reporting system – one in which consumers and healthcare professionals must devote considerable energy if they were so inclined to notify somebody about a side effect they attribute to a bio-pharmaceutical product. Adverse event reporting is infrequent and cumbersome because stakeholders are only vaguely aware of their responsibility and the current system is neither easy nor fast to use. Nor does it provide reporters with any immediate helpful feedback. With only a very small percentage of adverse drug events ever reaching the attention of manufacturers or regulators, it is easy to conclude that the medical community and the public may be wholly unaware of tremendous risks and liabilities that may be attributed to drug products. This workshop allows participation in insightful conversation on the future of our industry. Program: Fishbein, J: Introduction and closing remarks. Barrett, CP: Implementation of Post-marketing Risk Management Commitment. Laugel, I: The future of pharmacovigilance with the use of artificial intelligence sounds good. Marschler, M: The use of pharmacogenomic methodologies in the pharmacovigilance evaluation of medicinal products. This webinar meets two times. Fri, Jan 29, 2021 12:00 PM - 2:00 PM GMT Fri, Jan 29, 2021 6:00 PM - 8:00 PM GMT Register 2021-workshop-flier.pdf -
Content ArticleA conversation with John Wilkes (AstraZeneca), Clifford Berry (Takeda), Amy D. Wilson, Ph.D. (Biogen), and Jim Morris (NSF Health Sciences). This article is the second part of a two-part roundtable Q&A on the topic of human performance in pharmaceutical operations. Part 1 evaluated the underpinnings of human performance and provided advice to those individuals managing rapid production scale-up to support COVID-19 production demand. Here in Part 2, human performance in the context of investigation and CAPA programmes is considered.
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Content ArticleThe COVID-19 pandemic has exacerbated preexisting weaknesses in the global supply chain. Regional assessments by the Food and Drug Administration (FDA), European Medicines Agency (EMA), and independent consultants, have demonstrated various contributory causal factors requiring changes in policy, relationships, and incentives within the dynamic and developing networks. Human factors and ergonomics (HFE) is an approach that encourages sociotechnical systems thinking to optimize the performance of systems that involve human activity. The global supply chain can be considered such a system. However, it has neither been systematically examined from this perspective.
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Content ArticleCorporate interests have the potential to influence public debate and policymaking by influencing the research agenda, namely the initial step in conducting research, in which the purpose of the study is defined and the questions are framed. Fabbri et al. conducted a scoping review to identify and synthesise studies that explored the influence of industry sponsorship on research agendas across different fields. The authors concluded that corporate interests can drive research agendas away from questions that are the most relevant for public health. Strategies to counteract corporate influence on the research agenda are needed, including heightened disclosure of funding sources and conflicts of interest in published articles to allow an assessment of commercial biases. The authors also recommend policy actions beyond disclosure such as increasing funding for independent research and strict guidelines to regulate the interaction of research institutes with commercial entities.
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Content Article“Sunshine” policy, aimed at making financial ties between health professionals and industry publicly transparent, has gone global. Given that transparency is not the sole means of managing conflict of interest, and is unlikely to be effective on its own, it is important to understand why disclosure has emerged as a predominant public policy solution, and what the effects of this focus on transparency might be.
