Regulatory Rapporteur

 

Write to the Editor at publications@topra.org

February 2023  |  Volume 20  |  No.2

EDITORIAL

The need for robust quality management

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.

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By Donald Orloski and Jillian Stewart

FOCUS

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.

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By Lequina Myles 

FOCUS

Successful transition of your ISO 13485 QMS
from MDD/IVDD to MDR/IVDR

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.

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By Niamh Miller and Laura Taylor

FEATURE

A view of the environmental impact of pharmaceuticals

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.

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By Paul Kuiken and Caolan McGuinness

FEATURE

Patient information – why do things go wrong?

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.

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By Rory Littlebury

FEATURE

Regulation versus innovation in life sciences

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.

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By Richard Basset

FEATURE

Accelerated regulatory pathways:
vaccines for tropical diseases

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.

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By Bruno Speder, hVIVO, and TOPRA

FEATURE

In vitro diagnostics and medical devices –
post-market surveillance
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. 

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By Kirsten Van Garsse