Introduction

This chapter begins with the early regulation of medicines, which was concerned with quality rather than any scientific assessment of efficacy and safety. It describes the latter half of the nineteenth century wherein the need for objective scientific assessment of the safety and efficacy of new medicines and the concept of risk–benefit of medicines was born. It also talks about the configuration of the Licensing Authority in the UK and the European Medicines Evaluation Agency (EMEA) as a key provision of both the Medicines Act 1968 and the European medicines legislation. The chapter analyses Directive 2001/83/EC, which governs all the requirements for the contents of the application dossier and grant of marketing authorisation of medicinal products. It recounts the development of statutory controls in the UK that was consistent with the evolution of the overarching European medicines legislation and the formation of the central European regulatory agency.

Moving the National Institute of Justice Forward: July 2010 through December 2012

Criminologists are often frustrated by the disconnect between sound empirical research and public policy initiatives. Recently, there have been several attempts to better connect research evidence and public policy. While these new strategies may well bear fruit, I believe the challenge is largely an intellectual one. Ideas and research evidence must guide public policy and practice. In this article, I present highlights from my tenure as the Director of the National Institute of Justice (NIJ), the research, development, and evaluation agency in the Department of Justice. One of the ideas that I emphasized at NIJ was “Translational Criminology.” I believe translational criminology acknowledges NIJ’s unique mission to facilitate rigorous research that is relevant to the practice and policy. I also discuss the challenges I faced in bringing research to bear on public policy and practice. I end with a call for my colleagues in criminology and criminal justice to become more involved in government.

From Gaze Perception to Social Cognition: The Shared-Attention System

When two people look at the same object in the environment and are aware of each other’s attentional state, they find themselves in a shared-attention episode. This can occur through intentional or incidental signaling and, in either case, causes an exchange of information between the two parties about the environment and each other’s mental states. In this article, we give an overview of what is known about the building blocks of shared attention (gaze perception and joint attention) and focus on bringing to bear new findings on the initiation of shared attention that complement knowledge about gaze following and incorporate new insights from research into the sense of agency. We also present a neurocognitive model, incorporating first-, second-, and third-order social cognitive processes (the shared-attention system, or SAS), building on previous models and approaches. The SAS model aims to encompass perceptual, cognitive, and affective processes that contribute to and follow on from the establishment of shared attention. These processes include fundamental components of social cognition such as reward, affective evaluation, agency, empathy, and theory of mind.

Changes in the Influence of Social Responsibility Activities on Corporate Value over 10 Years in China

This study analyzes changes in how corporate social responsibility (CSR) affects corporate value in China. We use multiple regression analysis on a sample of A-share listed companies on the Shanghai and Shenzhen Stock Exchanges from 2009 to 2018. We divide the sample into 2009–2012 and 2013–2018 periods according to the development of CSR-related media and corporate policies. The dependent variable is corporate value, measured by Tobin’s Q. The independent variable is the CSR score calculated and published by RKS, a widely recognized CSR evaluation agency in China. We use firm size, sales growth rate, return on equity, top 10 shareholders’ equity, operating cash flow, and debt ratio as control variables. The panel-based regression models find no statistical correlation between CSR score and corporate value from 2009 to 2012 but find that the CSR score has a significantly positive influence on corporate value from 2013 to 2018. The impact of CSR activities on corporate value increases over the 10-year period. This decade saw the Chinese government shift its development strategy from a rapid growth model to a high-quality growth model and pursue sustainable development. This study is useful for Chinese companies considering adopting CSR activities to promote sustainable development.

In Vitro and In Vivo Models for Evaluating the Oral Toxicity of Nanomedicines

Toxicity studies for conventional oral drug formulations are standardized and well documented, as required by the guidelines of administrative agencies such as the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) or European Medicines Evaluation Agency (EMEA), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Researchers tend to extrapolate these standardized protocols to evaluate nanoformulations (NFs) because standard nanotoxicity protocols are still lacking in nonclinical studies for testing orally delivered NFs. However, such strategies have generated many inconsistent results because they do not account for the specific physicochemical properties of nanomedicines. Due to their tiny size, accumulated surface charge and tension, sizeable surface-area-to-volume ratio, and high chemical/structural complexity, orally delivered NFs may generate severe topical toxicities to the gastrointestinal tract and metabolic organs, including the liver and kidney. Such toxicities involve immune responses that reflect different mechanisms than those triggered by conventional formulations. Herein, we briefly analyze the potential oral toxicity mechanisms of NFs and describe recently reported in vitro and in vivo models that attempt to address the specific oral toxicity of nanomedicines. We also discuss approaches that may be used to develop nontoxic NFs for oral drug delivery.

Performance assessment of the Allplex™ STI Essential real-time PCR assay for the diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis infections in genital and extra-genital sites

Background Commercial kits performing Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) nucleic acid amplification tests (NAATs) for genital samples are recommended in association with culture, but the majority of real-time polymerase chain reaction (PCR) methods have not received regulatory approval for diagnostics in extra-genital sites. Since 2017, only the Hologic® Aptima Combo2 assay has an in vitro diagnostic (IVD) certification from the European Medicine Evaluation Agency. Methods We assessed the Allplex™ STI-Essential Assay (EA) for the diagnosis of NG and CT in both genital and extra-genital sites. The performance of the extraction step was studied by means of a standard curve between the concentration of expected cultivable gonococci and the cycle threshold (Ct). Three later-generation NAATs were used as comparators, particularly to assess the specificity (Sp). Results A relation between the gonococcal concentration, expressed as colony-forming unit (CFU) per milliliter logarithm, and the Ct was shown to be linear irrespective of the matrices (95% confidence interval [CI]). The detection limit was 10 CFU/mL, contrasting with the relatively poor sensitivity of culture due to inhibitory effects such as pH and the overgrowth of the commensal flora. NG molecular diagnostic is complex and the method comparisons showed some discrepancies when Ct was above 34. We decided to include interpretative comments on our reports on the basis of the Ct result. For CT, comparisons displayed a satisfactory agreement, and the detection limit was 50 copies/mL. Conclusions The Seegene Allplex™ STI-EA showed acceptable performance characteristics for the detection of genital and extra-genital NG and CT.

Clinical features of kidney involvement in microscopic microscopic polyangiitis

Aim. To evaluate clinical features and outcomes of renal involvement in patients with microscopic polyangiitis (MPA). Materials and methods: We enrolled 99 patients with MPA, diagnosed in accordance with the algorithm of the European Medicines Evaluation Agency (EMEA) and the Chapel Hill consensus conference definition (2012). Serum creatinine (sCr), estimated glomerular filtration rate (eGFR), hematuria and proteinuria were estimated. Frequency of rapidly progressive renal failure (a twofold increase in the sCr level in ≤3 months) was regarded as the clinical equivalent of rapidly progressive glomerulonephritis (RPGN). Results and discussion. Renal involvement was present in 92 (92.9%) patients. RPGN developed in 51 (55,4%) patients. The most common features of kidney involvement were hematuria and subnephrotic proteinuria. Arterial hypertension was revealed in 32 (34.7%) patients and was associated with RPGN (p

COMPARATIVE STUDY FOR GENERIC DRUG APPROVAL PROCESS AND THEIR REGISTRATION AS PER CTD IN EUROPE, USA AND BRAZIL

This aims to compare the generic drug approval and registration process in the regulatory market of Europe, USA andBrazil. Based on the information collected from various sources such as regulatory sites, Government websites,discussion with regulatory agent, interviewing pharma professionals and literature survey from various journals, aclear picture on the generic drug approval and registration process of each country was drawn. The differentauthorities’ viz. European Medicines Evaluation Agency (EMEA) of Europe, Food Drug Administration (FDA) ofUSA and National Health Surveillance Agency (ANVISA) of Brazil carried out the generic drug approval andregistration process in the respective countries. After analysing the various requirements for the generic drug approvalin the above stated countries, it was concluded that the regulatory guidelines of Europe and Brazil was not welldefined. But FDA gives very much well defined requirements.