Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
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South Africa and India’s request that the World Trade Organization waive intellectually property rights for COVID-19 vaccines, treatments, diagnostics and technology has garnered extensive media coverage, particularly since the US decision to support the proposal. In a three-part series, European Pharmaceutical Review’s Assistant Editor, Hannah Balfour, will discuss the IP…
Becoming a Benefit Corporation and a certified B Corp: how sustainability practices may positively impact business operations
In this article, Giacomo Chiesi from Chiesi Group outlines why the company took steps to become Benefit Corporation and B Corp certified, how this status may impact business and the associated operations.
In this article, Dr Ash Ramzan, principal consultant at Woodley BioReg, discusses the five key challenges preventing biosimilars from reaching their full potential.
This ebook from Sartorius takes an in-depth look at how the quality control (QC) microbiology laboratory plays a critical role in control of the pharmaceutical manufacturing environment and product release.
Pharma companies outsourcing clinical research support without focusing on safety are paying the price. Here, Natalia Vlcek, Pharmacovigilance Manager and EU QPPV at Arriello Group, offers some practical tips for ensuring best practice when it comes to safety in clinical research outsourcing.
In an ageing society where people are living longer, often with debilitating conditions that require complex medical interventions, how might the way we experience and consume our drugs be changed? In this article, Echo’s Nick Dormon discusses some of the key challenges currently facing pharmaceutical packaging design, including accessibility and…
In this article, EPR summarises the list of 10 recommendations for the UK Government, published by experts in the medicinal cannabis industry, to ensure the UK capitalises on the opportunities afforded by the market.
Marketing authorisation holders are increasingly challenged to identify all potential adverse events (AEs) and proactively address them with each new product that comes to market. In this article, Alison Sloane, General Manager of Vigilance Detect at IQVIA, discusses how adopting technology can not only streamline pharmacovigilance processes, but also address…
Here, Dr Matthew McMurray and Dr J Andrew Jones of Miami University explain why psychedelic drugs are attracting R&D as potential treatments for neuropsychiatric and degenerative disorders and how their discovery of an in vivo production technique could enable further advancement.
In this article, experts from Charles River Associates discuss how the introduction of cell and gene therapies will impact upon various aspects of the healthcare system, from provision of care to delivery and supply, and pricing and market access.
Ahmed Bouzidi, VP of Biotech Strategic Development at ProductLife Group, discusses the opportunities – and funding and regulatory challenges – facing small and mid-sized biopharma companies as they deliver innovation to the global market.
In this article, Shannon Flynn outlines six of the key risks threatening pharmaceutical manufacturers’ recovery from COVID-19 in 2021.
Susan Gosnell, product manager at NiceLabel, explores the potential labelling compliance issues for small medical device manufacturers and discusses how cloud labelling solutions could help combat them.
In this article, Liz Thorn, Senior Consultant, Diagnostics at Team Consulting, explores the various in vitro diagnostics (IVDs) techniques available and where they are best applied in the context of influenza and COVID-19.