scholarly journals Live biotherapeutic products: the importance of a defined regulatory framework

2020 ◽  
Vol 52 (9) ◽  
pp. 1397-1406 ◽  
Author(s):  
Magali Cordaillat-Simmons ◽  
Alice Rouanet ◽  
Bruno Pot
Keyword(s):  
Health Benefit ◽  
The United States ◽  
Regulatory Framework ◽  
European Medicines Agency ◽  
The European Union ◽  
Technical Requirements ◽  
Regulatory Constraints ◽  
Wide Range ◽  
The Impact ◽  
Intended Use

Abstract Probiotics have been defined as “Live microorganisms that when administered in adequate amounts confer a health benefit on the host”. This definition covers a wide range of applications, target populations and (combinations of) microorganisms. Improved knowledge on the importance of the microbiota in terms of health and disease has further diversified the potential scope of a probiotic intervention, whether intended to reach the market as a food, a food supplement or a drug, depending on the intended use. However, the increased interest in the clinical application of probiotics may require specific attention given their administration in a diseased population. In addition to safety, the impact of the type of product, in terms of quality, production method and, e.g., the acceptance of side effects, is now part of the current regulatory constraints for developers. In the European Union, foods are regulated by the European Food Safety Authority and drugs by the European Medicines Agency; in the United States, the Food and Drug Administration (FDA) deals with both categories. More recently, the FDA has defined a new “live biotherapeutic products” (LBP) category, clarifying pharmaceutical expectations. Since 2019, the quality requirements for this category of drug products have also been clarified by the European Pharmacopoeia (Ph. Eur.). Similar to all products intended to prevent or treat diseases, LBPs will have to be registered as medicinal products to reach the market in the US and in Europe. In this area, regulatory authorities and the pharmaceutical industry will routinely use guidelines of the “International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use” (ICH). Although ICH guidelines are not legally binding, they provide very important recommendations, recognized by almost all drug authorities in the world. In this review, we discuss some aspects of this regulatory framework, especially focusing on products with an intended use in a diseased or vulnerable target population.

Harmonization of Ethics Policies in Pediatric Research

2011 ◽  
Vol 39 (1) ◽  
pp. 70-78 ◽  
Author(s):  
Valarie Blake ◽  
Steve Joffe ◽  
Eric Kodish
Keyword(s):  
United States ◽  
European Union ◽  
Human Study ◽  
The United States ◽  
New Drugs ◽  
European Medicines Agency ◽  
The European Union ◽  
Drug Marketing ◽  
Technical Requirements ◽  
Recent Initiative

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation.

A New World Economic order formation

2021 ◽  
pp. 932-950
Author(s):  
Vladislav Vyacheslavovich Emelyanov
Keyword(s):  
Oil And Gas ◽  
World Order ◽  
The United States ◽  
New Order ◽  
The West ◽  
Wide Range ◽  
The World ◽  
The Usa ◽  
World Economic Order ◽  
The Impact

Every few decades, the world order changes due to various geopolitical, economic and other circumstances. For example, as a result of globalization, the world order has undergone significant changes in the last forty years. Globalization has led to the destruction of the postwar world order, as well as to world leadership by the United States and the West. However, in recent decades, as a result of globalization, the U.S. and the West began to cede their leadership to developing countries, so there is now a change in the economic structure of relations in the world system. Today the center of economic growth is in the East, namely in Asia. There are no new superpowers in the world at the moment, but the unipolar world will cease to exist due to the weakening of the U. S. leadership, which will lead to a change in the world order. A new leader, which may replace the U. S., will not have as wide range of advantages as the USA has. Most likely, the essence of the new order will be to unite the largest countries and alliances into blocks, for example, the USA together with the Trans-Pacific Partnership, the EU, etc. The article outlines forecasts of GDP growth rates as well as the global energy outlook; analyzes the LNG market as well as the impact of the pandemic on the global oil and gas market; and lists the characteristics of U. S. geopolitics.

scholarly journals Sustainability of micro-enterprises in the digital economy

2021 ◽  
Vol 250 ◽  
pp. 06008
Author(s):  
Oksana Mukhoryanova ◽  
Larisa Kuleshova ◽  
Nina Rusakova ◽  
Olga Mirgorodskaya
Keyword(s):  
Sustainable Development ◽  
The United States ◽  
Sharing Economy ◽  
Digital Economy ◽  
Small Enterprises ◽  
The European Union ◽  
The Sustainable Development ◽  
Traditional Industry ◽  
The Impact ◽  
Micro Enterprises

This paper aims at investigating the predisposition leading to the sustainability of micro-enterprises in the digital economy, especially the sharing economy. This area represents a new field since the research of the impact of the sharing economy on small enterprises is still in its infancy. We study the role of the entrepreneurial approach and entrepreneurial philosophy of the small business with regard to the digitalization and the sustainable development and growth using examples from the European Union and the United States. Some common features and trends are derived and the outcomes are discussed. Our results point at the fact that by creating an economy for micro-entrepreneurs, the sharing economy thrives on traditional industry disrupted by technology. Since micro-enterprises constitute a backbone of the economy in many developed and developing countries, more research is required to shed the light of the sustainable development of these types of enterprises in the globalized and digitalized world.

scholarly journals UNWTO World Tourism Barometer and Statistical Annex, October 2020

2020 ◽  
Vol 18 (6) ◽  
pp. 1-36 ◽  
Keyword(s):  
The United States ◽  
International Travel ◽  
International Tourism ◽  
The European Union ◽  
International Tourist ◽  
The Pacific ◽  
Slow Virus ◽  
Travel Restrictions ◽  
Main Barrier ◽  
The Impact

International travel plunges 70% in the first eight months of 2020 International tourist arrivals (overnight visitors) declined 70% in the first eight months of 2020 over the same period of last year, amid global travel restrictions including many borders fully closed, to contain the ongoing COVID-19 pandemic. International arrivals plunged 81% in July and 79% in August, traditionally the two busiest months of the year and the peak of the Northern Hemisphere summer season. Despite such large declines, this represents a relative improvement over the 90% or greater decreases of the previous months, as some destinations started to reopen to international tourism, mostly in the European Union. The decline in January-August 2020 represents 700 million fewer international tourist arrivals compared to the same period in 2019, and translates into a loss of US$ 730 billion in export revenues from international tourism, more than 8 times the loss in 2009 under the impact of the global economic crisis. Asia and the Pacific, the first region to suffer the impact of the pandemic, saw a 79% decrease in arrivals in January-August 2020. Africa and the Middle East both recorded a 69% drop this eight-month period, while Europe saw a 68% decline and the Americas 65%. Data on international tourism expenditure continues to reflect very weak demand for outbound travel, though in several large markets such as the United States, Germany and Italy there is a small uptick in spending in the months of July and August. Based on latest trends, a 75% decrease in international arrivals is estimated for the month of September and a drop of close to 70% for the whole of 2020. While demand for international travel remains subdued, domestic tourism is strengthening recovery in several large markets such as China and Russia. The UNWTO Confidence Index continues at record lows. Most UNWTO Panel Experts expect a rebound in international tourism by the third quarter of 2021 and a return to pre-pandemic 2019 levels not before 2023. Experts consider travel restrictions as the main barrier weighing on the recovery of international tourism, along with slow virus containment and low consumer confidence.

scholarly journals Path to European quantum unicorns

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Markku Räsänen ◽  
Henrikki Mäkynen ◽  
Mikko Möttönen ◽  
Jan Goetz
Keyword(s):  
Quantum Computing ◽  
The United States ◽  
Current Status ◽  
The European Union ◽  
Successful Business ◽  
The Creation ◽  
Quantum Technology ◽  
The Impact ◽  
Future Growth ◽  
The Eu

AbstractQuantum computing holds the potential to deliver great economic prosperity to the European Union (EU). However, the creation of successful business in the field is challenging owing to the required extensive investments into postdoctoral-level workforce and sophisticated infrastructure without an existing market that can financially support these operations.This commentary paper reviews the recent efforts taken in the EU to foster the quantum-computing ecosystem together with its current status. Importantly, we propose concrete actions for the EU to take to enable future growth of this field towards the desired goals. In particular, we suggest ways to enable the creation of EU-based quantum-computing unicorns which may act as key crystallization points of quantum technology and its commercialization. These unicorns may provide stability to the otherwise scattered ecosystem, thus pushing forward global policies enabling the global spread of EU innovations and technologies.The unicorns may act as a conduit, through which the EU-based quantum ecosystem can stand out from similar ecosystems based in Asia and the United States. Such strong companies are required because of the level of investment currently required in the marketplace. This paper suggests methodologies and best practices that can enhance the probability of the creation of the unicorns.Furthermore, we explore future scenarios, in which the unicorns can operate from the EU and to support the EU quantum ecosystem. This exploration is conducted focusing on the steps to be taken and on the impact the companies may have in our opinion.

scholarly journals Quebec’s Economic and Commercial Linkages with the United States, 1994–2017

2017 ◽  
Author(s):  
Earl H. Fry
Keyword(s):  
United States ◽  
Trade Agreement ◽  
The United States ◽  
The North ◽  
Nation States ◽  
Wide Range ◽  
The Us ◽  
Us Government ◽  
Big Picture ◽  
The Impact

This article examines the ebb and flow of the Quebec government’s economic and commercial relations with the United States in the period 1994–2017. The topic demonstrates the impact of three major forces on Quebec’s economic and commercial ties with the US: (1) the North American Free Trade Agreement (NAFTA) which became operational in 1994 and was fully implemented over a 15-year period; (2) the onerous security policies put in place by the US government in the decade following the horrific events of 11 September 2001; and (3) changing economic circumstances in the United States ranging from robust growth to the worst recession since the Great Depression of the 1930s. The article also indicates that the Quebec government continues to sponsor a wide range of activities in the United States, often more elaborate and extensive than comparable activities pursued by many nation-states with representation in the US. 1 1 Stéphane Paquin, ‘Quebec-U.S. Relations: The Big Picture’, American Review of Canadian Studies 46, no. 2 (2016): 149–61.

scholarly journals Criminal Liability of Medical Profecionals Negligience: Comparative Analysis

2020 ◽  
Vol 38 (Especial II) ◽  
pp. 251-263
Author(s):  
Kateryna Danchenko ◽  
Olga Taran
Keyword(s):  
Comparative Method ◽  
Criminal Liability ◽  
The United States ◽  
Medical Professionals ◽  
The European Union ◽  
Judicial Decision ◽  
Criminal Proceedings ◽  
Medical Office ◽  
The Us ◽  
The Impact

The purpose of this article is to study the criminal liability of medical professionals in cases of suspension, in accordance with jurisprudence in Ukraine, the European Union and the United States of America (USA). He made the comparative method. According to the investigation, the number of criminal proceedings in Ukraine by the authority and misconduct of medical doctors is about 2% per population, my figure that rises to 30% in Europe and is the stable yes in the US and is 28%. 32%. The main objective of the article is often area identify specializations in the medical office occurs with the mayor based on Ukrainian jurisprudence (data from Ukraine’s only state judicial decision register from 2016 to 2019). In addition, the study analyses the impact of the main influences on the ability of medical professionals for their professional functions. From counting the results show that surgeons, gynecologists, paramedics, and anesthesiologists are the most prone to deviation and medical error. Key proposed criteria have been proposed as medical errors differ from medical writing.

Duterte’s Foreign Policy Pivot and Its Impact on Philippine Trade and Investments: An International Political Economy Perspective

2020 ◽  
Vol 41 (1-2) ◽  
pp. 127-160
Author(s):  
Jenny D. Balboa
Keyword(s):  
Political Economy ◽  
Foreign Policy ◽  
International Political Economy ◽  
The United States ◽  
The Philippines ◽  
The Political ◽  
The European Union ◽  
Economic Relations ◽  
The Impact ◽  
Trade And Investment

Abstract Since the Philippines elected President Rodrigo Duterte in 2016, the country’s foreign policy seems to have become more uncertain. President Duterte’s mercurial personality and antagonistic tirades against the country’s traditional Western allies, including the United States (US) and the European Union (EU), and his statements of building closer ties with China and Russia, had changed the political and diplomatic tone of the Philippines overall. Certainly, the political relationship between the Philippines and the West has been changed by Duterte’s strong remarks against the US and EU. Has this change spilled over to the economy? The paper presents an international political economy framework in examining the impact of Duterte’s foreign policy pivot to the country’s foreign economic relations, focusing on trade and investment. The paper argues that Duterte’s foreign policy shift is mainly shaped by Duterte’s “politics of survival”. Not firmly anchored in any idea, norms, or interest that can clearly benefit the country, Duterte is unable to provide coherent guidance and leadership on the foreign policy pivot, particularly on the economy. Duterte’s lack of guidance provided the technocrats with the policy space to continue the policies from the previous administration and not to divert radically from previous economic policies. The stability of the economic institutions provided a refuge in the period of uncertainty. As a result, the foreign economic relations of the Philippines has not radically shifted. The trade and investment situation of the Philippines remained stable, and economic relations with traditional partners are maintained.

Cloudy days ahead: Cross-border evidence collection and its impact on the rights of EU citizens

2019 ◽  
Vol 10 (3) ◽  
pp. 227-250
Author(s):  
Lawrence Siry
Keyword(s):  
Law Enforcement ◽  
Cloud Storage ◽  
The United States ◽  
Legal Assistance ◽  
The European Union ◽  
Law Enforcement Agencies ◽  
Cross Border ◽  
Use Of Data ◽  
Evidence Collection ◽  
The Impact

In recent years, the development of cloud storage and the ease of cross-border communication have rendered the area of evidence collection particularly difficult for law enforcement agencies (LEAs), courts and academics. Evidence related to a criminal act in one jurisdiction might be stored in a different jurisdiction. Often it is not even clear in which jurisdiction the relevant data are, and at times the data may be spread over multiple jurisdictions. The traditional rules related to cross-border evidence collection, the mutual legal assistance treaty (MLAT) regimes, have proved to be out-dated, cumbersome and inefficient, as they were suited for a time when the seeking of cross-border evidence was more infrequent. In order to tackle this problem, the United States has enacted the Clarifying Lawful Overseas Use of Data Act, which gives extraterritorial e-evidence collection powers to US courts. Simultaneously, the European Union (EU) has proposed similar sweeping changes which would allow for LEAs in Member States to preserve and collect cloud-based evidence outside of the MLAT system. This article critically evaluates these developments from the perspective of the impact on the rights of EU citizens.

scholarly journals The Impact of International Sanctions on Russian Financial Markets

Economies ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. 107
Author(s):  
Mirzosaid Sultonov
Keyword(s):  
Exchange Rate ◽  
Stock Price ◽  
Price Index ◽  
The United States ◽  
The European Union ◽  
Stock Price Index ◽  
The Exchange Rate ◽  
Long Term Impact ◽  
The Impact

Russia’s international comportment and geostrategic moves, particularly the invasion of Ukraine and the annexation of Crimea in 2014, caused a substantial change in its international economic and political relations. In response to Russia’s invasion, the United States of America, the European Union, and their allies imposed a series of sanctions. In this study, by applying an exponential generalized autoregressive conditional heteroscedasticity model to daily logarithmic returns of the ruble exchange rate and the closing price index of the Russian Trading System, we analyze how the returns and volatility of the exchange rate and the stock price index responded to the sanctions and oil price changes. The estimation results show that the sanctions have a significant positive short-term impact on exchange rate returns. Economic sanctions have a significant negative long-term impact on the returns and variance of the exchange rate and a significant positive long-term impact on the returns of the stock price index. Financial sanctions have a positive/negative long-term impact on the returns of the exchange rate/stock price index and a positive long-term impact on the variance of the exchange rate and the stock price index. Corporate sanctions have a positive long-term impact on exchange rate returns.

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