All Regulatory Rapporteur articles in March 2023
View all stories from this issue.
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JournalDirect healthcare professional communication as an intervention tool – retrospective analysis
The direct healthcare professional communication (DHPC) is a communication intervention by which important safety information is delivered directly to individual healthcare professionals (HCPs), alerting them to take certain actions to ensure the safe and effective use of medicines.
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EditorialSetting 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 homogeneous or harmonised.
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JournalIs consulting in regulatory affairs your next career path?
Navigating the corporate ladder isn’t always clear cut. Along the way you may move in and out of the industry, stay in one position for too long, or even jump from specialist to director. Some ditch the politics all together and become their own boss. What is it like being a consultant, contingent worker, or contractor?
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JournalEMA’s IDMP-SPOR Implementation Guideline v2.1.1
Identification of Medicinal Products (IDMP) standards were developed by the ISO to specify the use of standardised definitions for the identification and description of medicinal products for human use. In this article, we provide an overview of the latest IDMP v2.1.1 guideline and summarise that, given the scope of changes, it is relatively low impact to the regulatory profession.
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JournalEnvironmental impact of pharmaceuticals and regulation in the EU
The profound impact of pharmaceuticals on the environment has been acknowledged for decades. In the EU, two key mechanisms that assess this risk are the Environmental Risk Assessment (ERA), and Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As both frameworks are under assessment, this article looks at the key considerations within the ERA.
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JournalIMDRF: Origins, purpose and current work
In a landscape of rapidly evolving technologies, the International Medical Device Regulatory Forum (IMDRF) aims to accelerate international medical device harmonisation. A summary of the work being undertaken by the IMDRF.
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Case StudyUnderstanding key components of a clinical evaluation
Written by Angela Siebeneck, Director of Regulatory Strategy and Policy from Certara based on an online seminar presentation, made in collaboration with TOPRA and Certera, given on 15 November 2022.