scholarly journals Regulatory Requirements for the Quality of Allergen Products for Allergen Immunotherapy of Food Allergy

2021 ◽  
Vol 21 (5) ◽  
Author(s):  
Lisa Englert ◽  
Vera Mahler ◽  
Andreas Bonertz
Keyword(s):  
Allergen Immunotherapy ◽  
Major Allergen ◽  
Food Allergies ◽  
Manufacturing Processes ◽  
Critical Element ◽  
Medicinal Products ◽  
Regulatory Requirements ◽  
Quality Aspects ◽  
Allergenic Activity ◽  
Recent Developments

Abstract Purpose of Review Medicinal products for allergen immunotherapy (AIT) of food allergies have gained enormous momentum in recent years. With this new class of products entering marketing authorization procedures, compliance to regulatory requirements becomes a critical element. Here, an overview is provided on specific requirements and aspects concerning the quality control and manufacturing of these products. Recent Findings Recent developments in the field of AIT for food allergies are divers, including products for oral, epicutaneous, and subcutaneous application, most notably targeting egg, milk, and peanut allergy. As the source materials for food AIT product are typically produced for food consumption and not for medicinal purposes, unique challenges arise in the manufacturing processes and controls of these medicinal products. Individual approaches are needed to assure acceptable quality, including control of relevant quantitative and qualitative characteristics. Major characteristics for quality verification include determination of protein content, total allergenic activity, and major allergen content. The applied manufacturing processes need to be established such that relevant process parameters are kept within justified limits and consistency of produced batches is assured. Summary Allergen products for food AIT present specific challenges with respect to quality aspects that differentiate them from other commonly available AIT products. While established regulation is available and provides clear guidance for most aspects, other issues require consideration of new and individual settings relevant here. Consequently, as experience grows, respective amendments to currently available guidance may be needed.

scholarly journals Analysis of Dyes in Cosmetics: Challenges and Recent Developments

Cosmetics ◽  
2018 ◽  
Vol 5 (3) ◽  
pp. 47 ◽  
Author(s):  
Eugenia Guerra ◽  
Maria Llompart ◽  
Carmen Garcia-Jares
Keyword(s):  
Decisive Role ◽  
Analytical Control ◽  
Synthetic Dyes ◽  
Regulatory Requirements ◽  
Cosmetic Product ◽  
Hydrophilic Nature ◽  
Cosmetic Ingredients ◽  
World Markets ◽  
Recent Developments

Colour plays a decisive role in the marketing of a cosmetic product. Among thousands of substances used to colour, synthetic dyes are the most widespread in the industry. Their potential secondary effects on human health and different regulatory requirements for their use between the main world markets make analytical control necessary to guarantee the safety of a cosmetic product. However, methodologies for the determination of dyes in cosmetics are scarce with respect to those reported for other cosmetic ingredients such as preservatives or ultraviolet UV filters. In addition, most of the existing methods just consider a part of the total of dyes regulated. On the other hand, many methods have been developed for matrices different than cosmetics such as foodstuff, beverages or wastewater. The current paper reviews the recent developments in analytical methodologies for the control of synthetic dyes in cosmetics proposed in the international scientific literature in the last 10 years (2008–2018). A trend towards the use of miniaturized extraction techniques is evidenced. Due to the hydrophilic nature of dyes, liquid chromatography is the most usual choice in combination with absorbance detectors and, more recently, with mass spectrometry.

scholarly journals Fintech and Payments Regulation

2020 ◽  
Vol 20 (75) ◽  
Author(s):  
Tanai Khiaonarong ◽  
Terry Goh
Keyword(s):  
Financial Stability ◽  
Analytical Framework ◽  
International Standards ◽  
Regulatory Requirements ◽  
Regulatory Frameworks ◽  
Structure Changes ◽  
Systemic Risks ◽  
Recent Developments ◽  
Legal Foundations ◽  
Financial Technology

Financial technology (Fintech) has prompted authorities to consider their potential financial stability benefits, risks, and effective regulation. Recent developments suggest that regulatory approaches and their legal foundations need to augment entity-based regulation with increasing focus on activities and risks as market structure changes. This paper draws on recent international experiences in modernizing legal and regulatory frameworks for payment services. An analytical framework based on a four-step process is proposed—(i) identifying payment activities; (ii) licensing entities and designating systems; (iii) analyzing and managing risks, and (iv) promoting legal certainty. As payment activities evolve and potential systemic risks heighten, adherence to international standards and additional regulatory requirements should be warranted.

scholarly journals A framework to support alien species regulation: the Risk Analysis for Alien Taxa (RAAT)

NeoBiota ◽  
2020 ◽  
Vol 62 ◽  
pp. 213-239 ◽  
Author(s):  
Sabrina Kumschick ◽  
John R. U. Wilson ◽  
Llewellyn C. Foxcroft
Keyword(s):  
South Africa ◽  
Sustainable Development ◽  
Risk Analysis ◽  
Well Being ◽  
Decision Makers ◽  
Regulatory Requirements ◽  
The World ◽  
Recent Developments ◽  
Almost All ◽  
New Framework

Human livelihoods and well-being in almost all regions of the world depend on taxa which are alien. Such taxa also, however, threaten human health, sustainable development, and biodiversity. Since it is not feasible or desirable to control all alien taxa, decision-makers increasingly rely on risk analyses to formalise the best available evidence of the threats posed and whether and how they can be managed. There are a variety of schemes available that consider the risks of alien taxa, but we argue a new framework is needed: 1) given major recent developments in international frameworks dealing with biological invasions (including the scoring of impacts); 2) so that decisions can be made consistently across taxa, regions and realms; 3) to explicitly set out uncertainties; and 4) to provide decision-makers with information both on the risks posed and on what can be done to mitigate or prevent impacts. Any such scheme must also be flexible enough to deal with constraints in capacity and information. Here we present a framework to address these points – the Risk Analysis for Alien Taxa (RAAT). It outlines a series of questions related to an alien taxon’s likelihood of invasion, realised and potential impacts, and options for management. The framework provides a structure for collating relevant data from the published literature to support a robust, transparent process to list alien taxa under legislative and regulatory requirements, with the aim that it can be completed by a trained science graduate within a few days. The framework also provides a defensible process for developing recommendations for the management of assessed taxa. We trialled the framework in South Africa and outline the process followed and some of the taxa assessed to date.

scholarly journals QUALITY ASPECTS OF TRUE ORTHOPHOTO IN URBAN AREAS

2020 ◽  
Vol XLIII-B5-2020 ◽  
pp. 191-198
Author(s):  
W. Ostrowski ◽  
V. D. Gulli ◽  
K. Bakula ◽  
Z. Kurczyński
Keyword(s):  
Image Matching ◽  
Urban Areas ◽  
Quantitative Methods ◽  
Quality Evaluation ◽  
Point Clouds ◽  
Dense Image ◽  
Quality Aspects ◽  
Surface Models ◽  
Recent Developments ◽  
2D Data

Abstract. Orthophotos are one of the most popular photogrammetric products and have been a leading source of up-to-date 2D data of urban areas for years. In the last few years, together with innovations in the area of Dense Image Matching, Digital Surface Models created with dense image matching start to be utilized as the height source during orthorectification. Recently this production workflow of true orthophotos were adopted to production standard in many countries. The aim of the presented research was to evaluate recent developments in the area of automatic true orthophoto generation for urban areas and to define factors which have the main influence on the quality of the final product. Obtained results showed that besides of the image overlap, the main factors which have direct influence on the resulted true orthophoto are the occurrence of shadows and vegetation (trees). One of the outcomes of the presented research was that the quantitative methods develop for quality evaluation of Digital Surface Models and Point Clouds are not directly transferable on the quality evaluation of true orthophotos.

scholarly journals COMPARATIVE STUDY OF REGULATORY REQUIREMENTS AND MARKETING AUTHORIZATION FOR MEDICINAL PRODUCTS IN EUROPEAN UNION AND ZIMBABWE

2018 ◽  
Vol 11 (10) ◽  
pp. 10
Author(s):  
Raju Kamaraj ◽  
Linda M Buruwe
Keyword(s):  
European Union ◽  
Comparative Study ◽  
New Drugs ◽  
Marketing Authorization ◽  
Medicinal Products ◽  
Regulatory Requirements ◽  
Regulatory Affairs ◽  
Comparison Results ◽  
Pharmaceutical Industries ◽  
Insight Into

The aim of this study is to evaluate the requirements for marketing authorization procedures of new drugs, generic medicines in developed countries such as Europe and to compare these procedures with those in developing countries such as Zimbabwe. Medicines control authority of Zimbabwe (MCAZ) grants the marketing authorization for medicinal products in Zimbabwe. However, there are still some gaps which need to be filled by the MCAZ to reach other bigger markets in the world. A comparative study of current MCAZ regulatory administration and practices with those of stringent regulators such as European Union will assist in the identification of these loopholes. It also provides the need for improvement with regard to pharmaceutical industries compliance with the relevant standards. This study will give a tremendous reassurance that the MCAZ regulatory affairs acquiescence is being met and gap analysis will systematically challenge the MCAZ regulatory requirements and procedures by comparing them to the European medicines agency regulatory guidelines, which will provide MCAZ with an insight into areas that have room for improvement. The study provides MCAZ with an insight into areas that have room for improvement. Current GMP Supervision of Manufactures and Inspections need to be upgraded; however, currently in Zimbabwe, there is inadequate internal audits, inadequate quality departments to do the validation and self-inspection in pharmaceutical industries. The comparison results obtained showed grey areas needed to be enhanced by MCAZ.

Neue Aspekte des Qualitätsmanagements. Ein Überblick über Neuerungen des Qualitätsmanagements im Krankenhaus

2019 ◽  
Vol 68 (5) ◽  
pp. 439-448
Author(s):  
Vanessa-Emily Schoch ◽  
Marleen Theresa Marleen Theresa
Keyword(s):  
Quality Management ◽  
Regulatory Requirements ◽  
New Developments ◽  
Gesetzliche Vorgaben ◽  
Business Perspective ◽  
Recent Developments ◽  
Technological Developments ◽  
Aktuelle Entwicklungen ◽  
Economic Constraints ◽  
Different Origins

Zusammenfassung Kliniken stehen zunehmend im Spannungsfeld ökonomischer Restriktionen, technologischer Entwicklungen, patientenorientierter Erwartungen und per­sonalabhängiger Möglichkeiten. Eine stetige Sicherung, Verbesserung und Erweiterung der Leistungsfähigkeit sind Aufgabenbereiche des Qualitätsmanagements. Die bisher primär betriebswirtschaftliche Ausrichtung lässt im Untersuchungszeitraum dieses Berichts eine Öffnung für erweiterte, gesellschafts­politische Fragestellungen erkennen. Forderungen nach Transparenz und Effizienz im klinischen Versorgungssystem werden sowohl durch gesetzliche Vorgaben als auch durch Eigeninitiativen gestützt. Die nachfolgend vorgestellte Literaturübersicht dokumentiert neuere Ansätze unterschiedlicher Provenienz zur Verbesserung anstehender Probleme. Sie verschafft einen Überblick über aktuelle Entwicklungen im Qualitätsmanagement und bietet zugleich Orientierungspunkte für die Entwicklung methodologisch fundierter interdisziplinärer Handlungsstrategien. Abstract: New Aspects of Quality Management. An Overview of New Developments in Quality Management in Hospitals Hospitals and clinics are nowadays facing severe challenges regarding economic constraints, technological developments, patient expectations and staff-related opportunities. A comprehensive quality management, that aims to ensure, improve and extend a hospital’s performance is one tool used to solve those challenges. So far, quality management has mainly been viewed from a business perspective. Contrary to that approach, this paper takes specific sociopolitical issues into account as well. The increased demand for transparency and efficiency are supported by both regulatory requirements and hospitals’ own initiatives. Based on a broad literature survey, the authors identify a variety of approaches from different origins to address current and future quality management challenges. The paper furthermore provides an overview over recent developments in the field of quality management. Additionally, this paper guides methodological interdisciplinary strategies.

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