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Showing results for tags 'Pharma / Life sciences'.
Found 60 results
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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 ArticleOver the past few years, concerns have been raised about the level of funding and intervention regulators have received from the pharmaceutical industry. In this article for The BMJ, investigative journalist Maryanne Demasi examines whether regulators of medical devices and medications have enough independence from the companies they are meant to regulate. She asked six of the world's biggest regulators about their funding and transparency and found that industry money permeates the world's leading regulators. This casts doubt on their ability to provide effective regulation, especially in the wake of a string of drug and device scandals.
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Content ArticleThis report by the consultancy firm Deloitte looks at patient safety across biopharmaceutical (biopharma) value chains, arguing that change is needed to make medications safer for patients and add value to pharmaceutical products. The authors highlight that there is currently great potential for strategies to increase safety, improve equity and enhance patient engagement and experience. Advances in artificial intelligence (AI) technologies and data analytics, combined with increased incidence of adverse event reports (AERs) and increasing expectation of more personalised, preventative, predictive and participatory (4P) medicine, present an opportunity to improve pharmacovigilance.
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Content ArticleDrugwatch is a US consumer advocacy organisation that works with certified medical and legal experts to educate the public on dangerous drugs and medical devices and to empower consumers to assert their legal rights. In this article, Terry Turner, writer for Drugwatch, examines the history of the medical tech company C.R. Bard, which specialises in vascular, urology, surgery and oncology devices. Bard manufactures thousands of medical devices and sells them worldwide. The article looks at how the company was established and then examines several legal issues Bard has faced, including criminal charges stemming from medical fraud and accusations of selling defective devices that have killed patients or caused serious complications. The author looks at criminal charges concerning heart catheters to which Bard pleaded guilty. They also highlight problems with Bard's transvaginal and hernia mesh products and inferior vena cava (IVC) filters—devices designed to catch blood clots before they reach the lungs or the heart.
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Content ArticleWe need a public register to show if healthcare professionals are in the pay of industry – or more patients will suffer, writes Margaret McCartney following the publication of the Independent Medicines and Medical Devices Safety Review. Hospitals in England are meant to publish registers of interest of staff – but a 2016 study shows that only a minority give the details they should. A publicly accessible digital register, updated at least annually and compelled by the regulator, would create transparency and get rid of the huge amount of work that campaigners have had to do to untangle where conflicts lie. Declarations alone can’t sort the problems of conflicted medicine. But a public register would allow us to know whose advice isn’t independent. We will still need to be alert to the unintended consequences of a register, and research will be needed. The UK is lagging behind. Kath Sansom, a journalist who founded the Sling the Mesh campaign, told Margaret: “I had no idea that I couldn’t trust my doctor or surgeon to give the best advice. It is essential that medics declare industry funding.”
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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 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 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 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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Content ArticleThis is the recording of a webinar hosted by The Patients Association, about working with partners in industry to allow patient voices to influence care and treatment. The webinar was part of Patient Partnership Week 2022 and featured: Sarah Louis, patient participant and Sarah Whitehead, External Relations and Public Affairs Manager, Novo Nordisk talking about a biosimilars project Carolyn Wheatley, patient participant and Robert Browne MSc, Senior Scientific Affairs Manager, Nutricia, talking about the nutrition checklist Fran Husson, patient participant and Dr Aman Gupta, Medical Affairs Manager Pfizer, on work in antimicrobial resistance.
