New Edition of the EAEU Good Pharmacovigilance Practice: What Has Changed?

In late 2016, the Council of the Eurasian Economic Commission adopted the first version of the Rules of Good Pharmacovigilance Practice of the Eurasian Economic Union (EAEU GVP Guideline) based on a similar pharmacovigilance guidance published in the EU in 2014. By Decision No.81 of 19.06.2022, the Council of the Eurasian Economic Commission has amended the EAEU GVP Guideline, and the new version has been effective since 06.12.2022. The amendment has introduced a major revision to the terminology and significant changes to the sections on the risk management system and on organisation of safety information and signal management. The current EAEU GVP Guideline includes new subsections and a reviewed procedure for submitting pharmacovigilance documents to the regulatory authorities.In this interview, we have discussed the importance of the newly introduced pharmacovigilance changes in EAEU member states for the pharmaceutical industry with Dmitriy A. Rozhdestvensky, Candidate of Medical Sciences, Head of the Section of Coordination of Activities in the Sphere of Circulation of Medicines and Medical Products of the Technical Regulation and Accreditation Department of the Eurasian Economic Commission

Robust two-dimensional subrecoil Raman cooling by adiabatic transfer in a tripod atomic system

We demonstrate two-dimensional robust Raman cooling in a four-level tripod system, in which velocity-selective population transfer is achieved by a STIRAP pulse. In contrast to basic 2D Raman cooling with square envelope pulses [Phys. Rev. A 83, 023407 (2011)], the technique presented here allows for a wide variation in the pulse duration and amplitude once the adiabaticity criterion is satisfied. An efficient population transfer together with attaining of a narrow spread of the resonant-velocity group leads to the narrowing of the velocity-distribution spread down to $0.1v_\mathrm{rec}$, corresponding to an effective temperature equal to $0.01 T_\mathrm{rec}$. This robust method opens new possibilities for cooling of neutral atoms.Comment: 8 pages, 3 figure

Methodology for failure analysis of complex technical systems and prevention of their consequences

The paper presents a study on the methodology of failures and their possible consequences analysis. Analysis of failures and their consequences is carried out for newly developed or modernized products and it is one of main activities in the reliability assurance system. The methodology is applied to the analysis of all designed systems, starting from the earliest stage of development, in order to evaluate the approach to development and compare the advantages of the design solution. The considered analysis of failures and their consequences of components is a part of the complex analysis of reliability of the whole product. Depending on the complexity of the design and the available data, a particular approach may be chosen for the analysis. In one case, it is a structural approach, in which a list of individual elements and their possible failures is compiled. In another case, it is the functional approach, which is based on the statement that each element must perform a number of functions that can be classified as solutions. The results provide a scheme for conducting the analysis and finding solutions to prevent them. The conclusions say that the level of detail determines the level at which failures are postulated

PEN: a low energy test of lepton universality

Allowed charged $\pi$ meson decays are characterized by simple dynamics, few available decay channels, mainly into leptons, and extremely well controlled radiative and loop corrections. In that sense, pion decays represent a veritable triumph of the standard model (SM) of elementary particles and interactions. This relative theoretical simplicity makes charged pion decays a sensitive means for testing the underlying symmetries and the universality of weak fermion couplings, as well as for studying pion structure and chiral dynamics. Even after considerable recent improvements, experimental precision is lagging far behind that of the theoretical description for pion decays. We review the current state of experimental study of the pion electronic decay $\pi^+ \to e^+\nu_e(\gamma)$, or $\pi_{e2(\gamma)}$, where the $(\gamma)$ indicates inclusion and explicit treatment of radiative decay events. We briefly review the limits on non-SM processes arising from the present level of experimental precision in $\pi_{e2(\gamma)}$ decays. Focusing on the PEN experiment at the Paul Scherrer Institute (PSI), Switzerland, we examine the prospects for further improvement in the near term.Comment: 11 pages, 5 figures; paper presented at the XIII International Conference on Heavy Quarks and Leptons, 22-27 May 2016, Blacksburg, Virginia, US

Адаптивные формирователи ортогональных составляющих сигналов для микропроцессорных защит

The paper considers adaptive shapers of orthogonal components of microprocessor protections of electrical installations. An algorithm for calculation of shapers of orthogonal signal components has been developed. In order to obtain frequency and dynamic characteristics of the shapers calculation experiments have been carried out. The obtained results of calculations demonstrate improvement quality of shaper characteristics.Рассматриваются адаптивные формирователи ортогональных составляющих микропроцессорных защит электроустановок. Был разработан алгоритм расчета формирователей ортогональных составляющих сигналов. С целью получения частотных и динамических характеристик формирователей проведены вычислительные эксперименты. Полученные’ результаты демонстрируют качество усовершенствования характеристик формирователей

PEN experiment: a precise measurement of the pi+ -> e+ nu decay branching fraction

A new measurement of $B_{\pi e2}$, the $\pi^+ \to e^+\nu(\gamma)$ decay branching ratio, is currently under way at the Paul Scherrer Institute. The present experimental result on $B_{\pi e2}$ constitutes the most accurate test of lepton universality available. The accuracy, however, still lags behind the theoretical precision by over an order of magnitude. Because of the large helicity suppression of the $\pi_{e2}$ decay, its branching ratio is susceptible to significant contributions from new physics, making this decay a particularly suitable subject of study.Comment: 4 pages, 3 figures, talk given at the Tenth Conference on the Intersections of Particle and Nuclear Physics (CIPANP 2009), La Jolla/San Diego, CA, 26-31 May 2009; to appear in Proceedings to be published by the American Institute of Physic