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Regulatory Rapporteur

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March 2023 | Volume 20 | No.3

EDITORIAL

Setting the right standards

The theme of this issue is global standards, but, as the contents reflect, the process by which documents and data become ‘standardised’ is anything but homogenous or harmonised.

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By Nancy Pire-Smerkanich and Steve Dew

FOCUS

IMDRF: origins, purpose and current work

In a landscape of rapidly evolving medical technologies, the Internationa Medical Device Regulatory Forum (IMDRF) looks to accelerate international medical device harmonisation. Many improvements need to be made in this sector, and this article summarises some of the work being undertaken by the IMDRF.

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By Mehryar Behizad

FOCUS

The EMA’s IDMP-SPOR Implementation Guideline v2.1.1

The Identification of Medicinal Products (IDMP) standards were developed to specify the use of standardised definitions for identification and description of medicinal products. This article provides an overview of the latest IDMP v2.1.1 guideline.

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By Vikrant Mahajan

FEATURE

Environmental impact of pharmaceuticals and regulation in the EU

The impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, the two key mechanisms that assess this risk are the Environmental Ris Assessment (ERA), and the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). This article looks at key considerations in these two frameworks.

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By Paul Kuiken and Caolan McGuinness

FEATURE

Understanding key components of a clinical evaluation

Clinical evaluation has become more complex, and it’s crucial to understand the guidance and regulations required in this changing field. This summary, based on a seminar presentation, provides guidance on the key evaluation areas, including the clinical evaluation plan and post-market clinical follow-up.

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By Angela Siebeneck

FEATURE

Direct healthcare professional communication
as an intervention tool –
retrospective analysis

The direct healthcare professional communication (DHPC) ensures that important safety information is delivered directly to individual healthcare professionals. This article explores the effectiveness of the DHPC, whihc is a topic of debate among regulatory professionals.

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By Ekaterina Pope