Historical preconditions of the creation of pharmacovigilance system in

The system of pharmacovigilance in the world appeared in response to series of tragedies related to the use of medicines. The largest of these were «sulfanilamide boom», «thalidomide tragedy» and «bomb with time mechanism». In Ukraine, the pharmacovigilance system has existed since 1996, and since 2002 Ukraine has been a member of the WHO international monitoring program for side effects. In 2000–2001 appeared the first orders of the Ministry of Health of Ukraine that regulated the implementation of pharmacovigilance in Ukraine, and in 2007, when the Order of the Ministry of Health of Ukraine № 898 came into force, the legislative framework in the pharmacovigilance system has been radically changed. This is connected with the reflection of the provisions of Directive 2001/83 / EC of the European Parliament and of the Council on the Community code relating to medicinal products in the order № 898. Today, the development of pharmacovigilance in Ukraine is carried out through adaptation to European legislation, which is stipulated by the Law of Ukraine «On the National Program of Adaptation of Ukrainian Legislation to the Law of the European Union». Among the prospects for the development of pharmacovigilance in Ukraine: - introduction of amendments and additions to the legislative base of Ukraine in the context of pharmacovigilance; - introduction of proactive management of the negative consequences of the use of drugs; - introduction of the Automated Information System with the Pharmacovigilance System (AISЗ) into the health care system of Ukraine; - dissemination of necessary knowledge about adverse reactions among the public, establishing the algorithm of action in case of an adverse reaction, the promotion of compliance and trust between the patient and the physician, reasoning of the rational, cautious and correct use of drugs and the prevention of self-treatment of serious conditions

Forward modeling of collective Thomson scattering for Wendelstein 7-X plasmas: Electrostatic approximation

In this paper, we present a method for numerical computation of collective Thomson scattering (CTS). We developed a forward model, eCTS, in the electrostatic approximation and benchmarked it against a full electromagnetic model. Differences between the electrostatic and the electromagnetic models are discussed. The sensitivity of the results to the ion temperature and the plasma composition is demonstrated. We integrated the model into the Bayesian data analysis framework Minerva and used it for the analysis of noisy synthetic data sets produced by a full electromagnetic model. It is shown that eCTS can be used for the inference of the bulk ion temperature. The model has been used to infer the bulk ion temperature from the first CTS measurements on Wendelstein 7-X

Towards a new image processing system at Wendelstein 7-X: From spatial calibration to characterization of thermal events

Wendelstein 7-X (W7-X) is the most advanced fusion experiment in the stellarator line and is aimed at proving that the stellarator concept is suitable for a fusion reactor. One of the most important issues for fusion reactors is the monitoring of plasma facing components when exposed to very high heat loads, through the use of visible and infrared (IR) cameras. In this paper, a new image processing system for the analysis of the strike lines on the inboard limiters from the first W7-X experimental campaign is presented. This system builds a model of the IR cameras through the use of spatial calibration techniques, helping to characterize the strike lines by using the information given by real spatial coordinates of each pixel. The characterization of the strike lines is made in terms of position, size, and shape, after projecting the camera image in a 2D grid which tries to preserve the curvilinear surface distances between points. The description of the strike-line shape is made by means of the Fourier Descriptors

Globally, songs and instrumental melodies are slower and higher and use more stable pitches than speech: A Registered Report

Both music and language are found in all known human societies, yet no studies have compared similarities and differences between song, speech, and instrumental music on a global scale. In this Registered Report, we analyzed two global datasets: (i) 300 annotated audio recordings representing matched sets of traditional songs, recited lyrics, conversational speech, and instrumental melodies from our 75 coauthors speaking 55 languages; and (ii) 418 previously published adult-directed song and speech recordings from 209 individuals speaking 16 languages. Of our six preregistered predictions, five were strongly supported: Relative to speech, songs use (i) higher pitch, (ii) slower temporal rate, and (iii) more stable pitches, while both songs and speech used similar (iv) pitch interval size and (v) timbral brightness. Exploratory analyses suggest that features vary along a “musi-linguistic” continuum when including instrumental melodies and recited lyrics. Our study provides strong empirical evidence of cross-cultural regularities in music and speech