Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC (
) to IVDR 2017/746
. Without amendments and ...contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infrastructural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its “
”.
This study focused on the official control activities carried out during an 8-year period by the competent authority charged with safeguarding the public health with regards to histamine presence in ...fish. Samples of raw and processed fish products were collected from establishments of production, supermarkets, restaurants, and other customer services, rather than foodborne outbreaks causing hospitalization and medical treatment. They were analyzed by HPLC with diode array detector after derivatization with dansyl-chloride. A total of 59 (19.5%) out of 303 examined batches showed histamine concentrations below the maximum limits set by the Commission Regulation (EC) No 2073/2005, while further 18 (5.9%) resulted non-compliant. In the last case, the follow up procedure was activated for the corresponding sampling sites in the subsequent years. A statistically significant difference (p < 0.01) was observed between anchovy and all the investigated species except for tuna, as well as between raw and processed fish products not distinguished by fish species. The comparison of batches collected in cold and hot months was not statistically significant (p > 0.05). The results of this survey suggest a special attention to the quality of raw material, storage temperature and hygiene practices during both handling and processing of fish and fish products.
•Histamine detection in fish products collected during official controls in 8-year survey.•Description of foodborne outbreaks and liaison with fish species and product category.•Activation of the follow up procedure for non-compliant samples.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Human mathematical competence emerges from two representational systems. Competence in some domains of mathematics, such as calculus, relies on symbolic representations that are unique to humans who ...have undergone explicit teaching. More basic numerical intuitions are supported by an evolutionarily ancient approximate number system that is shared by adults, infants and non-human animals-these groups can all represent the approximate number of items in visual or auditory arrays without verbally counting, and use this capacity to guide everyday behaviour such as foraging. Despite the widespread nature of the approximate number system both across species and across development, it is not known whether some individuals have a more precise non-verbal 'number sense' than others. Furthermore, the extent to which this system interfaces with the formal, symbolic maths abilities that humans acquire by explicit instruction remains unknown. Here we show that there are large individual differences in the non-verbal approximation abilities of 14-year-old children, and that these individual differences in the present correlate with children's past scores on standardized maths achievement tests, extending all the way back to kindergarten. Moreover, this correlation remains significant when controlling for individual differences in other cognitive and performance factors. Our results show that individual differences in achievement in school mathematics are related to individual differences in the acuity of an evolutionarily ancient, unlearned approximate number sense. Further research will determine whether early differences in number sense acuity affect later maths learning, whether maths education enhances number sense acuity, and the extent to which tertiary factors can affect both.
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DOBA, IJS, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Master protocols combine several sub-trials, each with their own research objectives, which is usually presented as one single clinical trial application. Master protocols have become increasingly ...popular in oncology and haematology, as either basket, umbrella, or platform trials. Although master protocols are intended to accelerate drug development and to reduce futility, their use poses challenges to ethics committees, patients, study investigators, and competent authorities during the review and authorisation process of a clinical trial application. In this Personal View, we review the experiences of clinical trial applications from two European medical regulators—the Danish Medicines Agency and the German Federal Institute for Drugs and Medical Devices. We view master protocols as a good opportunity to identify new treatment options more quickly, particularly for patients with cancer. However, the complexity of trial documentation, the amount of information resulting from sub-trials, and the volume of changes and amendments made to clinical trial applications can cause issues during trial supervision, and during the analysis and review of a corresponding application for marketing authorisation. We draw attention to the potential issues arising from these trial concepts and propose possible solutions to avoid problems during clinical trial authorisation and trial conduct.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
As compared with Europe, the United States generally requires more rigorous clinical testing of high-risk devices, which delays patients' access to new devices but may provide better assurance of ...device safety.
Millions of patients worldwide depend on an ever-widening array of medical devices for the diagnosis and management of disease. In the United States, the Food and Drug Administration (FDA) requires manufacturers of high-risk devices such as heart valves and intraocular lens implants to demonstrate safety and effectiveness before the devices can be marketed. However, some policymakers and device manufacturers have characterized U.S. device regulation as slow, risk-averse, and expensive.
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,
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Other experts, such as those at the Institute of Medicine, have suggested that current premarketing procedures may not be comprehensive enough and may be particularly dangerous for devices that have . . .
One of the most sensitive activities in the online environment is to ensure the security of information managed by entities, persons, or public institutions that are stored and traded through IT&C ...systems in the new technological context. New innovative technologies, in addition to their value, can also have negative sides with security in the digital world, and this is an increasingly common topic in the discussions in this area. Not all security incidents can be prevented, but proactive measures to mitigate their impact must be taken in any context. Information, like any critical resource of any organization, is one of the most important components for businesses operating in the European Union and therefore its protection requires particular attention. Sensitive information has become the target of increasingly numerous and diverse threats and attacks in both the public and private sectors. Cyber security measures can protect organizations from multiple threats to business continuity, data veracity, and increase resilience to cyber-attack and minimize the risk of information theft. In order to try to mitigate as many of the issues described above as possible, the European Commission has initiated the process of revising Directive (EU) 2016/1148 on the security of network and information systems (NIS Directive) since June 2020. On 16 December 2020, the Commission launched the proposal for a NIS 2.0 Directive which will be submitted for debate and approval in the European Parliament. One of the major changes brought about by the new Directive is that the Public Administration becomes a sector covered by the new Directive. Under the new regulations in the proposed NIS 2.0 Directive, the scope of activities covered by the national competent authority in the field of cyber security (CERT-RO cf. Law 362/2018) extends to this new sector, which will explicitly include ministries and agencies of the state, the territorial extensions of the central administration, as well as the structures of the local public administration.
Assessment is performed by the national competent authority of the country acting as a Reference Member State (RMS) and recognised by the Concerned Member States (CMS), i.e., other countries involved ...in the authorisation procedure.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
10.
Bureaucratic Competence and Procurement Outcomes Decarolis, Francesco; Giuffrida, Leonardo M; Iossa, Elisabetta ...
Journal of law, economics, & organization,
11/2020, Volume:
36, Issue:
3
Journal Article
Peer reviewed
Open access
Abstract
To what extent does a more competent public bureaucracy contribute to better economic outcomes? We address this question in the context of the US federal procurement of services and works, ...by combining contract-level data on procurement performance and bureau-level data on competence and workforce characteristics. We use the death occurrences of specific types of employees as instruments and find that an increase in bureau competence causes a significant and economically important reduction in (a) time delays, (b) cost overruns, and (c) number of renegotiations. Cooperation within the office appears to be a key driver of the findings. (JEL D73, H11, H57, L26).
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