All Regulatory Rapporteur articles in February 2023
View all stories from this issue.
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JournalAccelerated regulatory pathways: Vaccines for tropical diseases
Reproduced from an online seminar presentation, made in collaboration with TOPRA and hVIVO, given on 21 June 2022 by Bruno Speder from hVIVO.
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EditorialThe need for robust quality management
It is a simple fact that the establishment of a robust quality management system (QMS) can both drive – as well as facilitate – regulatory compliance across all layers of business and operations in the pharma and MedTech industries. However, there is no doubt that the mention of QMS can ...
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JournalRegulation versus innovation in life sciences
With Regulations evolving to meet the needs of changing technologies, demographics and health care practices, regulatory affairs professionals must ensure that the ever-changing requirements placed upon product or manufacturers are met and where possible met at minimal costs. Within this article we look to find innovative approaches to meet the different priorities which aim to reduce economic industry burden and ensure product availability.
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JournalIVDs and medical devices — post-market surveillance and clinical follow-up requirements
Written by Kirsten Van Garsse from Qarad (part of the QbD Group) based on an online seminar presentation, made in collaboration with TOPRA and QbD, given on 6 December 2022 by Kirsten Van Garsse and Anne-Sophie Grell from QbD.
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JournalPatient information — why do things go wrong?
Are common root causes leading to the pharmaceutical industry being non-compliant with the legal obligation to keep authorised product information up to date?
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JournalA View of…The Environmental Impact of Pharmaceuticals
The body of research being published which is focused on the environmental impact of pharmaceuticals is increasing rapidly. It highlights a growing concern among the public for medicinal products accumulating in the natural world through a variety of originating sources.
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JournalQuality management systems — applying good distribution practices to the biopharmaceutical supply chain
Biopharmaceutical supply chain strategies and alignment with good distribution practices (GDPs) are often viewed and planned with a focus on the post-marketing stage. Although this approach is valid, GDP compliance and supply chain strategies have important implications even during the clinical phases of product development. GDP regulations ensure that the integrity of medicinal products is maintained throughout all stages of the supply chain, from the manufacturer’s site to the pharmacy, or person authorised to supply to the public.
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JournalSuccessful transition of your ISO 13485 QMS from MDD/IVDD to MDR/IVDR
The new requirements in the MDR/IVDR will affect the QMS of medical device manufacturers, however, use of the ISO 13485 standard is a useful starting point in meeting many of these requirements. The use of a gap analysis, project implementation plan, and ISO 13485 provide an approach that will allow manufacturers to successfully transition from MDD/IVDD to MDR/IVDR.