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Enticing Local Governments to Produce FAIR Freedom of Information Act Dossiers
Government transparency is central in a democratic society, and increasingly governments at all levels are required to publish records and data...
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Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019
BackgroundQuality by Design (QbD) is a systematic risk-based approach to development, with predefined characteristics and quality risk management...
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Safety profile of herbal medicines submitted for marketing authorization in Tanzania: a cross-sectional retrospective study
BackgroundThe popular use of herbal medicines necessitates national regulatory authorities to have efficient mechanisms for the control of these...
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Sha** a suitable EU HTA dossier template: why the German template is not fit for purpose
From 2025, Health Technology Developers (HTDs) have to submit EU HTA dossiers. The joint clinical assessment (JCA) aims to streamline HTA processes...
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Socio-economic analysis in REACH restriction dossiers for chemicals management: A critical review
This paper offers a critical review of socio-economic analysis (SEA) in Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)...
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Dossier Novels: The Reader as Detective
This chapter examines lists in the context of dossier novels and uses Charles Warren Adams’s The Notting Hill Mystery (1865) and the Murder Dossier...
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Defence of Biocidal Active Substance Dossiers in the Context of Regulatory Toxicology
In this chapter, the expertise gathered in the broad area of toxicology and its implementation into the regulatory context is illustrated using the...
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Defence of Biocidal Active Substance Dossiers in the Context of Regulatory Toxicology
In this chapter, the expertise gathered in the broad area of toxicology and its implementation into the regulatory context is illustrated using the...
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Ethnicity-Specific Drug Safety Data in European Medicines Agency Registration Dossiers, European Public Assessment Reports, and European and Singapore Drug Labels: Lost in Translation?
BackgroundInformation on drug safety in different ethnic populations reported in public documents such as the European Public Assessment Reports...
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Una muestra bibliográfica [A Bibliographic Sampling] of Latin American Digital Poetry (So Far)
This bibliography is composed of key dossiers, edited books, monographs, and special journal issues, all of which represent important touchstones in...
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Data in CIB
This chapter addresses the three fundamental data objects needed for CIB analysis: descriptors, descriptor variants, and cross-impact data. The basic...
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Role of Economic Evaluations on Pricing of Medicines Reimbursed by the Italian National Health Service
ObjectiveThe main objective of this study was to explore the extent to which the incremental cost-effectiveness ratio (ICER), alongside other...
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Non-disclosure of developmental neurotoxicity studies obstructs the safety assessment of pesticides in the European Union
BackgroundIn the European Union (EU), the safety assessment of plant protection products relies to a large extent on toxicity studies commissioned by...
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Career Opportunities in Toxicology
In Chap. 4 , an overview is given of the career opportunities for toxicologists in the pharmaceutical...
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State of the practice of health information systems: a survey study amongst health care professionals in intellectual disability care
BackgroundCare for people with an Intellectual Disability (ID) is complex: multiple health care professionals are involved and use different Health...
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Huiselijk geweld (inclusief kindermishandeling)
Bij vermoedens van geweld en onveiligheid voor kinderen is er de wettelijke plicht de meldcode te hanteren. Deze is doorlopend aan ontwikkeling...
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KI-gestütztes Recruiting – technische Grundlagen, wirtschaftliche Chancen und Risiken sowie ethische und soziale Herausforderungen
When recruiting new employees, companies today increasingly rely on the support of artificial intelligence (AI). The technical possibilities range...
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10 Years of AMNOG: What is the Willingness-to-Pay for Pharmaceuticals in Germany?
ObjectivesThe German Pharmaceutical Market Restructuring Act (AMNOG, 2011) is a two-stage process to regulate the price of new pharmaceuticals in...
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Der Lernmanager als post-panoptische Kommunikationsplattform
Die Digitalisierung bietet neue technische Möglichkeiten zur Individualisierung des Unterrichts. Während die Entwicklung von Lernsoftware das...