scholarly journals Emerging technologies and their impact on regulatory science

2021 ◽  
pp. 153537022110522
Author(s):  
Elke Anklam ◽  
Martin Iain Bahl ◽  
Robert Ball ◽  
Richard D Beger ◽  
Jonathan Cohen ◽  
...  
Keyword(s):  
New Technologies ◽  
Emerging Technologies ◽  
Cost Effective ◽  
Assessment Tools ◽  
Regulatory Science ◽  
Science Field ◽  
Regulatory Decision ◽  
Technical Advances ◽  
Novel Approaches ◽  
Regulatory Decisions

There is an evolution and increasing need for the utilization of emerging cellular, molecular and in silico technologies and novel approaches for safety assessment of food, drugs, and personal care products. Convergence of these emerging technologies is also enabling rapid advances and approaches that may impact regulatory decisions and approvals. Although the development of emerging technologies may allow rapid advances in regulatory decision making, there is concern that these new technologies have not been thoroughly evaluated to determine if they are ready for regulatory application, singularly or in combinations. The magnitude of these combined technical advances may outpace the ability to assess fit for purpose and to allow routine application of these new methods for regulatory purposes. There is a need to develop strategies to evaluate the new technologies to determine which ones are ready for regulatory use. The opportunity to apply these potentially faster, more accurate, and cost-effective approaches remains an important goal to facilitate their incorporation into regulatory use. However, without a clear strategy to evaluate emerging technologies rapidly and appropriately, the value of these efforts may go unrecognized or may take longer. It is important for the regulatory science field to keep up with the research in these technically advanced areas and to understand the science behind these new approaches. The regulatory field must understand the critical quality attributes of these novel approaches and learn from each other's experience so that workforces can be trained to prepare for emerging global regulatory challenges. Moreover, it is essential that the regulatory community must work with the technology developers to harness collective capabilities towards developing a strategy for evaluation of these new and novel assessment tools.

scholarly journals IDENTIFICATION OF TECHNOLOGY INTEGRATION CHALLENGES AT TWO GLOBAL AUTOMOTIVE OEMS

2020 ◽  
Vol 1 ◽  
pp. 2245-2254
Author(s):  
I. Alonso Fernández ◽  
M. Panarotto ◽  
O. Isaksson
Keyword(s):  
Technology Integration ◽  
Automotive Industry ◽  
New Technologies ◽  
Emerging Technologies ◽  
Cost Effective ◽  
Product Variety ◽  
Technological Innovations ◽  
Platform Design ◽  
Product Platforms

AbstractPlatform design has been firmly established in the automotive industry as a strategy to provide wider product variety while maintaining cost effective production. But this strategy can struggle to keep up with the pace and nature of emerging technologies. This paper reviews the existing approaches to modelling product platforms, and showcases the challenges at OEMs introducing new technological innovations in their platforms. A gap is identified in the methods to assess the ability of existing platforms to integrate new technologies whenever they become available.

scholarly journals Current and Future Trends in Life Sciences Training: Questionnaire Study

10.2196/15877 ◽  
2020 ◽  
Vol 6 (1) ◽  
pp. e15877
Author(s):  
William Magagna ◽  
Nicole Wang ◽  
Kyle Peck
Keyword(s):  
Emerging Technologies ◽  
Life Sciences ◽  
Continuing Professional Development ◽  
Cost Effective ◽  
Science Field ◽  
Current State ◽  
The Future ◽  
Training Professionals ◽  
The Status

Background Every year, the life science field spends billions of dollars on educational activities worldwide. The continuing professional development of employees, especially in this field, encompasses great challenges. Emerging technologies appear to offer opportunity, but relatively little research has been done on the effectiveness of pedagogies and tools that have been used in the life sciences, and even less research has been devoted to understanding the potential power of emerging options that might determine the field’s future. Objective In collaboration with the Life Sciences Trainers & Educators Network (LTEN), this study investigated the current state of the pedagogies and tools currently adopted by corporate training professionals in the life sciences as well as the professionals’ perceptions of the impacts of emerging technologies on training. Methods This study adopted a mixed methods approach that included a survey and a follow-up interview. The survey consists of 18 broad questions with 15 subquestions in each of the five specific sectors of the life sciences field. Interviews were conducted by phone and lasted approximately 40 minutes, covering 18 questions designed to follow-up on findings from the survey items. Results Both survey and interview results indicated that the professionals were not satisfied with the status quo and that training and education in this field need to change. Most of the techniques and tools currently used have been used for some time. The professionals surveyed were not satisfied with the current techniques and tools and did not find them cost-effective. In addition, the respondents pictured the future of training in this field to be more engaging and effective. Conclusions This is the first study in a series designed to better understand education and training in the life sciences on a macro level, in order to build a foundation for progress and evolution of the future landscape. Next steps involve developing strategies for how to extend this vision throughout individual organizations.

scholarly journals Regulatory landscapes for biomarkers and diagnostic tests: Qualification, approval, and role in clinical practice

2017 ◽  
Vol 243 (3) ◽  
pp. 256-261 ◽  
Author(s):  
William B. Mattes ◽  
Federico Goodsaid
Keyword(s):  
Product Development ◽  
Diagnostic Tests ◽  
New Technologies ◽  
Biomarker Discovery ◽  
Medical Product ◽  
The Road ◽  
Regulatory Decision ◽  
The Us ◽  
Recent Developments ◽  
Regulatory Decisions

While the term ‘biomarker’ is relatively new, the concept is millennia old. However, with the introduction of new technologies to discover potential biomarkers comes the need to assess their utility and veracity for any given use. This is particularly true for the use of biomarkers to support regulatory decisions in medical product development. Hence the US Food and Drug Administration has developed processes for the qualification of biomarkers and other medical product development tools, processes that are underscored by recent legislation (i.e. the 21st Century Cures Act). In addition to these qualification processes, diagnostic tests that measure a biomarker may follow a process for regulatory decision through the processes that evaluate companion diagnostics. This mini-review provides an overview of these processes and their role in pharmaceutical development and clinical use. Impact statement This work summarizes very recent developments in the US FDA’s biomarker qualification program. Furthermore, it contrasts biomarker qualification with companion diagnostic evaluation. As such, it will be highly informative for researches considering taking a biomarker discovery farther along the road to validation.

scholarly journals Regulator Reputation and Stakeholder Participation: A Case Study of the UK’s Regulatory Sandbox for Fintech

2021 ◽  
pp. 1-20
Author(s):  
Lauren FAHY
Keyword(s):  
New Technologies ◽  
Emerging Technologies ◽  
Stakeholder Participation ◽  
High Technology ◽  
Future Research ◽  
High Performing ◽  
Regulatory Decision ◽  
Study Questionnaire ◽  
Critical Challenge

This article contributes to the discussion about managing the risks and uncertainties of emerging technologies through increased stakeholder participation. Authorities have increasingly invited stakeholders from high-technology sectors to participate in assessing the risks of, and designing responses to, new technologies. Yet authorities often struggle to attract stakeholders from such sectors to participate; a critical challenge identified but still undertheorised in the literature. Responding to this gap, this article presents a case study of the UK’s regulatory sandbox for financial technologies, applying a document study, questionnaire and interviews to explore fintech firm motivations and apprehensions about participation. Drawing on the bureaucratic reputation literature, the study finds that fintech firms have a range of practical, reputational and normative motivations to participate, and these motivations are inextricably tied to the regulator’s strong reputation with the sector as procedurally correct, high-performing and morally committed to facilitating innovation. On this basis, recommendations for practitioners and hypotheses for future research into the drivers of stakeholder participation in regulatory decision-making surrounding emerging technologies are proposed.

Technology Assessment in the EU Institutions

2011 ◽  
Vol 6 (5) ◽  
pp. 522-527
Author(s):  
Michael D. Rogers ◽  
Keyword(s):  
Technology Assessment ◽  
New Technologies ◽  
Decision Makers ◽  
Regulatory Decision ◽  
Advisory Groups ◽  
Formal Requirement ◽  
Regulatory Impact ◽  
The Right ◽  
Regulatory Decisions ◽  
The Eu

Technology Assessment (TA) is the study and evaluation of new technologies with the objective of understanding the likely impacts (costs and benefits) of these technologies on society and the environment – with the explicit aim of improving regulatory decision making concerning these technologies. This is a prospective exercise helping to ensure that “better” regulatory decisions are made by decision makers. TA and “TA like” activities are embedded within the main EU institutions. The Commission carries out Regulatory Impact Assessments on every significant regulatory proposal. It also has at its disposal a range of advisory groups which includes the European Group on Ethics in Science and New Technologies and the Institute for Prospective Technological Studies. The European Parliament has its own TA unit – the Science and Technology Options Assessment unit. The institutions are committed to quality, transparency and effectiveness in their use of expert groups and all such assessments are published on the internet. Occasionally full citizens’ consultations are carried out but this is not a formal requirement. Recent changes in the regulatory development process have emphasised the concept of “smarter” regulations. This concept is concerned not just with prospective analyses in advance of new regulations but also with the retrospective evaluation of existing regulations asking the question“Did they meet the need that was the raison d’être for enacting the regulation under consideration.”The distinction highlighted by Churchill [2] that experts should advise but not decide is intended to ensure that regulators take account of aspects other than the expert view. Nevertheless, it is essential that expert groups have the right to introduce advice thatmight otherwise be overlooked by the regulators, as is the case in a number of expert groups in the EU institutions.

The Impact of Emerging Technologies on the Law of Armed Conflict

2019 ◽  
Keyword(s):  
Armed Conflict ◽  
New Technologies ◽  
Emerging Technologies ◽  
Legal Issues ◽  
Technological Advancement ◽  
Law Of Armed Conflict ◽  
Legal Challenges ◽  
Challenges And Opportunities ◽  
The Law ◽  
The Impact

Emerging technologies have always played an important role in armed conflict. From the crossbow to cyber capabilities, technology that could be weaponized to create an advantage over an adversary has inevitably found its way into military arsenals for use in armed conflict. The weaponization of emerging technologies, however, raises challenging legal issues with respect to the law of armed conflict. As States continue to develop and exploit new technologies, how will the law of armed conflict address the use of these technologies on the battlefield? Is existing law sufficient to regulate new technologies, such as cyber capabilities, autonomous weapons systems, and artificial intelligence? Have emerging technologies fundamentally altered the way we should understand concepts such as law-of-war precautions and the principle of distinction? How can we ensure compliance and accountability in light of technological advancement? This book explores these critical questions while highlighting the legal challenges—and opportunities—presented by the use of emerging technologies on the battlefield.

scholarly journals Innovating on Inhaled Bioequivalence: A Critical Analysis of the Current Limitations, Potential Solutions and Stakeholders of the Process

Pharmaceutics ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 1051
Author(s):  
Jonattan Gallegos-Catalán ◽  
Zachary Warnken ◽  
Tania F. Bahamondez-Canas ◽  
Daniel Moraga-Espinoza
Keyword(s):  
New Technologies ◽  
Innovation Process ◽  
Cost Effective ◽  
Regulatory Agencies ◽  
Drug Products ◽  
Effective Strategies ◽  
Rate Analysis ◽  
Orally Inhaled Drug Products ◽  
Next Generation Impactor ◽  
First Time

Orally inhaled drug products (OIDPs) are an important group of medicines traditionally used to treat pulmonary diseases. Over the past decade, this trend has broadened, increasing their use in other conditions such as diabetes, expanding the interest in this administration route. Thus, the bioequivalence of OIDPs is more important than ever, aiming to increase access to affordable, safe and effective medicines, which translates into better public health policies. However, regulatory agencies leading the bioequivalence process are still deciding the best approach for ensuring a proposed inhalable product is bioequivalent. This lack of agreement translates into less cost-effective strategies to determine bioequivalence, discouraging innovation in this field. The Next-Generation Impactor (NGI) is an example of the slow pace at which the inhalation field evolves. The NGI was officially implemented in 2003, being the last equipment innovation for OIDP characterization. Even though it was a breakthrough in the field, it did not solve other deficiencies of the BE process such as dissolution rate analysis on physiologically relevant conditions, being the last attempt of transferring technology into the field. This review aims to reveal the steps required for innovation in the regulations defining the bioequivalence of OIDPs, elucidating the pitfalls of implementing new technologies in the current standards. To do so, we collected the opinion of experts from the literature to explain these trends, showing, for the first time, the stakeholders of the OIDP market. This review analyzes the stakeholders involved in the development, improvement and implementation of methodologies that can help assess bioequivalence between OIDPs. Additionally, it presents a list of methods potentially useful to overcome some of the current limitations of the bioequivalence standard methodologies. Finally, we review one of the most revolutionary approaches, the inhaled Biopharmaceutical Classification System (IBCs), which can help establish priorities and order in both the innovation process and in regulations for OIDPs.

scholarly journals 400 - Effects of Computerized Cognitive Training with an Elderly Community Sample

2020 ◽  
Vol 32 (S1) ◽  
pp. 116-116
Author(s):  
M Pires ◽  
A Antunes ◽  
C Gameiro ◽  
C Pombo
Keyword(s):  
Older Adults ◽  
Cognitive Training ◽  
New Technologies ◽  
Community Sample ◽  
Cost Effective ◽  
Well Being ◽  
Control Group ◽  
Depression Symptoms ◽  
Intensive Training ◽  
Before And After

Community-focused programs that promote active and healthy aging can help preserve cognitive capacities, prevent or reverse cognitive deficits. Computer-based cognitive training (CCT) is a promising non-pharmacological, cost -effective and accessible intervention to face the effects of age-related cognitive decline. Previous studies proved CCT to have equal or better efficacy compared to traditional interventions. This comparative multifactorial study aims to test the efficacy of a CCT in a non-randomized community sample of 74 older adults: G1-CCT Experimental group (n=43) (Mean age M=72.21, SD=12.65) and G2- Paper-Pencil Control group (n=31; M=77.94, SD=10.51). Pensioners (97.3%), mostly women (83.8 %) with basic education (51.4%) and without dementia diagnosis, completed a cognitive training program of 17 or 34 group sessions (twice a week). G2 undertook a classic cognitive paper-pencil stimuli tasks. G1, performed, additionally, individual CCT with COGWEB® in a multimodal format (intensive training of attention, calculation, memory, gnosis, praxis, executive functions). Both groups completed Portuguese versions of Mini -Mental State Examination (MMSE),Montreal Cognitive Assessment (MOCA); Geriatric Depressive Scale (GDS); Mini Dependence Assessment (MDA); WHOOQL 5 and Social Support Satisfaction Scale (ESSS) before and after participating in the program. Both groups reported better post-test scores on basic cognitive functions (MMSE, MOCA), Depression symptoms (GDS-30), subjective well-being and quality of life (WHOOQL-5). G1 presented higher MOCA and lower GDS scores before and after CCT, although, group differences become less expressive when interaction effects are considered. Results are in line with findings from past studies, CCT supported by the new technologies, is as a relevant cost-effective therapeutic tool for health professionals working with older adults. Particularly for preventive purposes of neuro-cognitive disorders.

Sign in / Sign up

Export Citation Format

Share Document