The Experts below are selected from a list of 252 Experts worldwide ranked by ideXlab platform
Ethan Basch - One of the best experts on this subject based on the ideXlab platform.
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Patient-reported outcome measures in safety event reporting: PROSPER consortium guidance
Drug Safety, 2013Co-Authors: Anjan K. Banerjee, Stephen J. Mayall, Bruno Flamion, Charles Cleeland, Sally Okun, Paul Wicks, I. Ralph Edwards, Meredith Y Smith, Ethan BaschAbstract:The Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium was convened to improve safety reporting by better incorporating the perspective of the patient. PROSPER comprises industry, regulatory authority, academic, private sector and patient representatives who are interested in the area of patient-reported outcomes of adverse events (PRO-AEs). It has developed guidance on PRO-AE data, including the benefits of wider use and approaches for data capture and analysis. Patient-reported outcomes (PROs) encompass the full range of self-reporting, rather than only patient reports collected by clinicians using validated instruments. In recent years, PROs have become increasingly important across the spectrum of healthcare and life sciences. Patient-centred models of care are integrating shared decision making and PROs at the point of care; comparative effectiveness research seeks to include patients as participatory stakeholders; and industry is expanding its involvement with patients and patient groups as part of the drug development process and safety monitoring. Additionally, recent pharmacovigilance legislation from regulatory authorities in the EU and the USA calls for the inclusion of patient-reported information in benefit-Risk Assessment of pharmaceutical products. For patients, technological advancements have made it easier to be an active participant in one's healthcare. Simplified internet search capabilities, electronic and personal health records, digital mobile devices, and PRO-enabled patient online communities are just a few examples of tools that allow patients to gain increased knowledge about conditions, symptoms, treatment options and side effects. Despite these changes and increased attention on the perceived value of PROs, their full potential has yet to be realised in pharmacovigilance. Current safety reporting and Risk Assessment Processes remain heavily dependent on healthcare professionals, though there are known limitations such as under-reporting and discordant perspectives between patient reports and clinician perceptions of adverse outcomes. PROSPER seeks to support the wider use of PRO-AEs. The scope of this guidance document, which was completed between July 2011 and March 2013, considered a host of domains related to PRO-AEs, including definitions and suitable taxonomies, the range of datasets that could be used, data collection mechanisms, and suitable analytical methodologies. PROSPER offers an innovative framework to differentiate patient populations. This framework considers populations that are prespecified (such as those in clinical trials, prospective observational studies and some registries) and non-prespecified populations (such as those in claims databases, PRO-enabled online patient networks, and social websites in general). While the main focus of this guidance is on post-approval PRO-AEs from both prespecified and non-prespecified population groups, PROSPER has also considered pre-approval, prespecified populations. The ultimate aim of this guidance is to ensure that the patient 'voice' and perspective feed appropriately into collection of safety data. The guidance also covers a minimum core dataset for use by industry or regulators to structure PRO-AEs (accessible in the online appendix) and how data, once collected, might be evaluated to better inform on the safe and effective use of medicinal products. Structured collection of such patient data can be considered both a means to an end (improving patient safety) as well as an end in itself (expressing the patient viewpoint). The members of the PROSPER Consortium therefore direct this PRO-AE guidance to multiple stakeholders in drug safety, including industry, regulators, prescribers and patients. The use of this document across the entirety of the drug development life cycle will help to better define the benefit-Risk profile of new and existing medicines. Because of the clinical relevance of 'real-world' data, PROs have the potential to contribute important new knowledge about the benefits and Risks of medicinal products, communicated through the voice of the patient.
Theo Vermeire - One of the best experts on this subject based on the ideXlab platform.
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Evaluation of EU Risk Assessments Existing Chemicals(EC Regulation 793/93)
Chemosphere, 2003Co-Authors: C.w.m. Bodar, F. Berthault, J.h.m. De Bruijn, C. J. Van Leeuwen, Marja E.j. Pronk, Theo VermeireAbstract:An evaluation was performed on the first group (41) of completed Risk Assessments for chemicals of the EU priority lists (Existing Chemicals; EC Regulation 793/93). The evaluation focussed on the conclusions of the Risk Assessments. The EU Risk Assessment process detected a high number of substances of concern. Furthermore priority chemicals may pose potential Risks to the whole range of protection goals of the Risk Assessment. The predictability of the Risk Assessments for priority chemicals was investigated. Our a priori knowledge on possible Risks of priority chemicals is found to be poor, especially for consumers. Both for environment and human health the potential Risks were linked with a broad spectrum of use patterns. It is concluded that no industry category can in advance be excluded from performing Risk Assessments. For a great number of chemicals, additional testing was found to be needed to finalise the Risk Assessment. This evokes questions about the completeness of the current base-set, but also about the suitability of some of the submitted human health tests that should initially fulfil the base-set needs. The results of this evaluation are useful for ongoing discussions on Risk Assessment Processes for chemicals.
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evaluation of eu Risk Assessments existing chemicals ec regulation 793 93
Chemosphere, 2003Co-Authors: C.w.m. Bodar, F. Berthault, J.h.m. De Bruijn, C. J. Van Leeuwen, Marja E.j. Pronk, Theo VermeireAbstract:An evaluation was performed on the first group (41) of completed Risk Assessments for chemicals of the EU priority lists (Existing Chemicals; EC Regulation 793/93). The evaluation focussed on the conclusions of the Risk Assessments. The EU Risk Assessment process detected a high number of substances of concern. Furthermore priority chemicals may pose potential Risks to the whole range of protection goals of the Risk Assessment. The predictability of the Risk Assessments for priority chemicals was investigated. Our a priori knowledge on possible Risks of priority chemicals is found to be poor, especially for consumers. Both for environment and human health the potential Risks were linked with a broad spectrum of use patterns. It is concluded that no industry category can in advance be excluded from performing Risk Assessments. For a great number of chemicals, additional testing was found to be needed to finalise the Risk Assessment. This evokes questions about the completeness of the current base-set, but also about the suitability of some of the submitted human health tests that should initially fulfil the base-set needs. The results of this evaluation are useful for ongoing discussions on Risk Assessment Processes for chemicals.
I. Rosenthal - One of the best experts on this subject based on the ideXlab platform.
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The Chemical Accident Risk Assessment Thesaurus: A Tool for Analyzing and Comparing Diverse Risk Assessment Processes and Definitions
Risk Analysis, 2001Co-Authors: A. J. Ignatowski, I. RosenthalAbstract:The Chemical Accident Risk Assessment Thesaurus (CARAT) is a database of the laws, regulations, guidance documents, and definitions of terms related to the Risk Assessment of accidental releases of chemicals from fixed installations. The database also contains information on the application of Risk Assessment methodologies to specific examples of potential chemical releases. The Organization for Economic Cooperation and Development urged the development of the Thesaurus to improve the communication among the member countries about the Risk Assessment of hazardous installations. The difficulty of communication is based in large part on the fact that certain “terms of art†have different meanings in different countries and cultures, or that different terms of art are used to address the same concept. The CARAT is designed to circumvent these difficulties, and is especially useful as a tool to analyze the definitions of terms related to Risk Assessment. Entries into the CARAT contain information from various international, national, and regional agencies that relate to Risk Assessment Processes and definitions focused on accidental chemical releases. The entire system is accessible via the Internet. Retrieval of information from the CARAT is facilitated by five different searching tools: two of them are designed to search the CARAT for its entries. One facility is designed to search for laws and regulations, specific Risk Assessment cases (SRA), and Risk Assessment guidance documents (RAG) related to chemical accidents. The second search facility deals with entries of definitions. The design of the CARAT is ideally suited to capture the sense of definitions that are expressed as either a procedural definition (an “operation on a concept†) or a conceptual definitions (just the “concept†). A powerful third query tool is the “Comparison†facility. This query tool allows the user to compare the details CARAT entries of laws and regulations, SRA, RAG, or definitions, in any combination. The remaining two tools can perform searches by identifying entries that contain either certain combinations of hierarchical or descriptor details. Both types can be conducted in Boolean “and/or†mode.
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the chemical accident Risk Assessment thesaurus a tool for analyzing and comparing diverse Risk Assessment Processes and definitions
Risk Analysis, 2001Co-Authors: A. J. Ignatowski, I. RosenthalAbstract:The Chemical Accident Risk Assessment Thesaurus (CARAT) is a database of the laws, regulations, guidance documents, and definitions of terms related to the Risk Assessment of accidental releases of chemicals from fixed installations. The database also contains information on the application of Risk Assessment methodologies to specific examples of potential chemical releases. The Organization for Economic Cooperation and Development urged the development of the Thesaurus to improve the communication among the member countries about the Risk Assessment of hazardous installations. The difficulty of communication is based in large part on the fact that certain "terms of art" have different meanings in different countries and cultures, or that different terms of art are used to address the same concept. The CARAT is designed to circumvent these difficulties, and is especially useful as a tool to analyze the definitions of terms related to Risk Assessment. Entries into the CARAT contain information from various international, national, and regional agencies that relate to Risk Assessment Processes and definitions focused on accidental chemical releases. The entire system is accessible via the Internet. Retrieval of information from the CARAT is facilitated by five different searching tools: two of them are designed to search the CARAT for its entries. One facility is designed to search for laws and regulations, specific Risk Assessment cases (SRA), and Risk Assessment guidance documents (RAG) related to chemical accidents. The second search facility deals with entries of definitions. The design of the CARAT is ideally suited to capture the sense of definitions that are expressed as either a procedural definition (an "operation on a concept") or a conceptual definitions (just the "concept"). A powerful third query tool is the "Comparison" facility. This query tool allows the user to compare the details CARAT entries of laws and regulations, SRA, RAG, or definitions, in any combination. The remaining two tools can perform searches by identifying entries that contain either certain combinations of hierarchical or descriptor details. Both types can be conducted in Boolean "and/or" mode.
Enrico Sabbioni - One of the best experts on this subject based on the ideXlab platform.
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Promotion of research on in vitro immunotoxicology
Science of The Total Environment, 2001Co-Authors: Michael Balls, Enrico SabbioniAbstract:ECVAM was established to play a leading role at the European level in the independent evaluation of the reliability and relevance of test methods and testing strategies for specific purposes through research on advanced methods and new test development and validation, so that chemicals and products of various kinds, including medicines, vaccines, medical devices, cosmetics, household products and agricultural products, can be manufactured, transported and used more economically and more safely, whilst the current relevance on animal test procedures is progressively reduced. Nowhere is this activity more necessary than in the field of immunotoxicology, where we know that chemicals and products of many kinds have the potential to stimulate, modulate or suppress the induction or expression of various types of immune responses. The problem is to effectively evaluate the potency of these effectors, and, since the available information is currently based on rather qualitative animal tests, to evaluate the true relevance of this knowledge and apply it intelligently in Risk Assessment Processes which will protect human beings without unnecessarily limiting the development and use of materials which otherwise have economic, health and social benefits. The way forward must depend on the following: (a) a better understanding of immunotoxicological Processes, based on a sounder understanding of the immune system itself (and of its network of control systems and interrelationships with other body systems); (b) The use of in vitro (not in vivo) systems based on human (not animal) cells and tissues; (c) integrated and tiered testing strategies, incorporating QSAR, as well as in vitro approaches; (d) taking advantage of the use of cells or factors from humans who have been exposed to potential immunotoxins, be this voluntarily, occupationally, environmentally or by accident; and (e) the recognition that virtually everything will effect one or more aspects of the immune system at some dose level and, in some circumstances, deciding when such effects are relevant, is the key to immunotoxicity testing. Some current ECVAM-sponsored work and activities at ECVAM are described.
Mohammed Ahmad Naheem - One of the best experts on this subject based on the ideXlab platform.
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regulating virtual currencies the challenges of applying fiat currency laws to digital technology services
Journal of Financial Crime, 2018Co-Authors: Mohammed Ahmad NaheemAbstract:The purpose of this paper is to consider the recent (Dec`15) introduction of the Bitlicensing rules in New York and consider from a banking perspective how this will impact on their own Risk Assessment Processes. The paper also outlines the challenges of applying financial regulation to companies that have an area of expertise and business that is more aligned to software development, rather than financial service provision.,This paper is a viewpoint paper, which offers a critical discussion on the FATF guidelines on virtual currencies. The paper compares developments that are currently occurring within the virtual currency sector in particularly the new Bitlicensing process in New York State and discusses the implications to the banking sector on Risk Assessment Processes for virtual currency transactions.,This paper will benefit the banking and regulation industries as well as economic and banking academics and anyone with an interest in virtual and digital currency technology.,This paper is unique in that it examines the issue of virtual currency regulation from a banking perspective. It explains the virtual currency technology as a means to be enhancing banking Risk Assessment, for clients seeking to incorporate virtual currency transactions into their business. This paper impacts on the banking and regulatory sectors because it critically examines the current practice of over regulation and the impact that this has on alternative financial systems, such as digital and virtual currencies. The paper offers a theoretical framework as well as citing current practical reports of how regulation has already started to affect the financial services landscape. The impact of getting this wrong can lead to increased criminal activity, and this paper highlights how susceptible the financial sector is to this.
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Regulating virtual currencies – the challenges of applying fiat currency laws to digital technology services
Journal of Financial Crime, 2018Co-Authors: Mohammed Ahmad NaheemAbstract:The purpose of this paper is to consider the recent (Dec`15) introduction of the Bitlicensing rules in New York and consider from a banking perspective how this will impact on their own Risk Assessment Processes. The paper also outlines the challenges of applying financial regulation to companies that have an area of expertise and business that is more aligned to software development, rather than financial service provision.,This paper is a viewpoint paper, which offers a critical discussion on the FATF guidelines on virtual currencies. The paper compares developments that are currently occurring within the virtual currency sector in particularly the new Bitlicensing process in New York State and discusses the implications to the banking sector on Risk Assessment Processes for virtual currency transactions.,This paper will benefit the banking and regulation industries as well as economic and banking academics and anyone with an interest in virtual and digital currency technology.,This paper is unique in that it examines the issue of virtual currency regulation from a banking perspective. It explains the virtual currency technology as a means to be enhancing banking Risk Assessment, for clients seeking to incorporate virtual currency transactions into their business. This paper impacts on the banking and regulatory sectors because it critically examines the current practice of over regulation and the impact that this has on alternative financial systems, such as digital and virtual currencies. The paper offers a theoretical framework as well as citing current practical reports of how regulation has already started to affect the financial services landscape. The impact of getting this wrong can lead to increased criminal activity, and this paper highlights how susceptible the financial sector is to this.
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Trade based money laundering: A primer for banking staff
International Journal of Disclosure and Governance, 2017Co-Authors: Mohammed Ahmad NaheemAbstract:Purpose: What are the reason(s) for writing the paper and the aims of the research? – This article provides a detailed overview of the Risks associated with trade-based money laundering and in particular the use of free trade zones. The purpose of the article is to inform the development of Risk-based Assessments within the banking sector on trade-based money laundering. It offers findings from research conducted by the author and other academic findings on areas to focus on in Risk Assessment. Design/Methodology/Approach: How are the objectives achieved? Include the main method(s) used for the research. What is the approach to the topic and what is the theoretical or subject scope of the article ? – The article uses a number of sources of secondary data, including FATF reports, the Wolfsberg Principles and current research into TBML and the banking sector. It also uses findings from research by the author. The subject scope is trade-based money laundering (TBML). Findings: What was found in the course of the work? This will refer to analysis, discussion, or results – The main findings from the analysis are that banks have a greater legal and regulatory responsibility towards detecting and reporting suspicious transactions than they would have previously considered. This includes identifying the source and purpose of fund transfers related to trade and shipping finance and establishing the beneficial ownership of clients and the businesses in which they are working. The article highlights the inherent Risks associated with free trade zones and the need for a greater level of awareness across all units of the bank on Risk Assessment from TBML crimes. Research limitations/implications (if applicable): If research is reported on in the article this section must be completed and should include suggestions for future research and any identified limitations in the research process – The article is a viewpoint paper but is based on forthcoming research by the author and uses an extensive literature-based research analysis. Practical implications (if applicable): What outcomes and implications for practice, applications and consequences are identified? How will the research impact upon business or enterprise? What changes to practice should be made as a result of this research? What is the commercial or economic impact? Not all papers will have practical implications – The research article has identified a number of implications to the banking sector on addressing Anti-Money Laundering (AML) deficiencies, especially the need to improve standards of beneficial ownership verification and CDD checks for business clients involved in trading and shipping. It also has implications for IT development within this sector for all agencies working on TBML crimes. Social implications (if applicable): What will be the impact on society of this research? How will it influence public attitudes? How will it influence (corporate) social responsibility or environmental issues? How could it inform public or industry policy? How might it affect the quality of life? Not all papers will have social implications – This article has implications for the global banking sector. It will also influence approaches to AML regulation, Risk Assessment and audit within the broader financial services sector. In addition it has implications for agencies working on TBML, including law enforcement, customs, governments and tax and revenue investigators. Originality/Value: What is new in the article ? State the value of the article and to whom – The originality of this article is the in-depth discussion on TBML and banking Risk Assessment Processes.
