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February 2023 | Volume 20 | No.2
A robust quality management system (QMS) can drive and facilitate regulatory compliance across all layers of business and operations in pharma and medtech industries. In this issue, we focus on two specific aspects of QMS.
By Donald Orloski and Jillian Stewart
Quality management systems:
applying good distribution practices
to the biopharmaceutical supply chain
It is important to ensure that your quality management system (QMS) is aligned with good distribution practice (GDP) regulations. This article discusses the requirements and benefits of GDP.
By Lequina Myles
The new requirements in the Medical Device Regulation (MDR)/In Vitro Diagnostics Regulation (IVDR) will affect medical device manufacturers’ quality management systems (QMS). This article provides guidance on navigating the transition from the Medical Device Directive (MDD)/In Vitro Diagnostics Directive (IVDD), to the MDR/IVDR.
By Niamh Miller and Laura Taylor
The impact of pharmaceuticals on the environment is a significant concern. Greater awareness of environmental risks, attributed to human activity, is forcing governments to review regulation. This article discusses the extent of pharmaceutical pollution and anticipates future action to migitate it.
By Paul Kuiken and Caolan McGuinness
It is a crucial objective for industry and its regulators to ensure that patients and healthcare professionals have accurate information about medicines. This research identifies common issues industry may face when updating product information.
By Rory Littlebury
Regulations are always evolving to meet the needs of changing technologies, and regulatory affairs professionals must meet these ever-changing requirements. This article looks at innovative approaches to meet the different priorities whihc aim to reduce budget.
By Richard Basset
Tropical diseases affect nearly one billion people yearly, despite advancement in global pharmaceutical research. This summary, based on an online seminar presentation by hVIVO, explores how human challenge trials can support the development of treatments for these diseases and accelerate their regulatory approval.
By Bruno Speder, hVIVO, and TOPRA
In vitro diagnostics and medical devices –
and clinical follow-up requirements
In vitro diagnostics and medical devices may be subject to post-market changes. Therefore, it is important for manufacturers to continuously collect and analyse data on their devices, post market. This summary, based on an online seminar presentation by QBD and TOPRA, provides an overview of post-market surveillance procedures for in-vitro diagnostics and medical devices.
By Kirsten Van Garsse