scholarly journals Artificial Hair: By the Dawn to Automatic Biofibre® Hair Implant

2017 ◽  
Vol 6 (1) ◽  
pp. 156-162 ◽  
Author(s):  
Maria Roccia ◽  
Katlein França ◽  
David Castillo ◽  
Georgi Tchernev ◽  
Uwe Wollina ◽  
...  
Keyword(s):  
Twentieth Century ◽  
European Union ◽  
North America ◽  
Medical Treatment ◽  
Medical Devices ◽  
Medical Personnel ◽  
The European Union ◽  
Restoration Technique ◽  
Appropriate Treatment ◽  
Improper Use

Since the beginning of the twentieth century, there have been attempts at creating artificial hair to treat baldness. Major evolution took place at the end of 1970’s when, unfortunately, artificial hair treatments were applied without appropriate medical controls, resulting in sub-standard results from the use of unsuitable materials and technique. The large improper use of this technique in North America from no medical personnel and with dangerous fibres led the Food and Drug Administration (FDA) to suspend the procedure in 1983. In Europe, a new trial on artificial hair procedure started at the beginning of 1990’s.In 1995 the European Union (UE) recognised the artificial hair implant as a legitimate medical treatment and outlined the rules related to that procedure. In 1996, biocompatible fibres (Biofibre®) produced by Medicap® Italy were approved by the UE Authorities and by the Australian Therapeutic Goods Administration (TGA) as medical devices for hair implant. An effective medical protocol was developed during the following years to provide correct guidelines for appropriate treatment, and to reduce possible related complications. Automatic Biofibre® hair implant represents the last achievement in this hair restoration technique with significant advantages for the patients.

Migration and outward FDI: a double direction approach

2018 ◽  
Vol 28 (2) ◽  
pp. 240-257 ◽  
Author(s):  
Jorge Alcaraz ◽  
Elizabeth Salamanca
Keyword(s):  
European Union ◽  
Latin America ◽  
Social Network ◽  
North America ◽  
International Migration ◽  
Network Theory ◽  
Social Network Theory ◽  
Best Interests ◽  
The European Union ◽  
Content Type

Purpose The purpose of this study is to identify, based on social network theory, the relationship between the direction of international migration (immigration/emigration) and the international movement of enterprises and their location. Design/methodology/approach A traditional gravity model and the Tobit estimation method are applied to three groups of countries from three different regions: Latin America, North America and the European Union. The study considers a period from 2001 to 2012. Findings The main results suggest that the international migration that goes from the European Union and North America to Latin America is related with the firms’ internationalization and their respective location. Practical implications Given that migration can be an important and reliable source of information, trust and knowledge, managers should see it as a “bridge” between the home and host countries, which, in turn, can increase their competitive advantage. Social implications Governments can learn how migration and outward foreign direct investment interact. In addition, they could develop political frameworks to accurately and effectively manage international migration (immigration and emigration) and FDI in the best interests of the stakeholders. Originality/value This study extends the social network theory by suggesting that networks are not only related with firms’ expansion abroad but as well with their location. This statement could be generalizable as long as emigration/networks (ethnic ties) are considered the links between the home and the host country.

A Regulatory and Safety Perspective on Medical Devices

2021 ◽  
pp. 1815-1826
Author(s):  
Carla Pires ◽  
Dinah Duarte
Keyword(s):  
European Union ◽  
Adverse Events ◽  
Member State ◽  
Medical Devices ◽  
Future Development ◽  
The European Union ◽  
Serious Adverse Events ◽  
International Laws ◽  
Counterfeit Products

In the European Union (EU), medical devices (MD) industry is a representative employer, with the MD sales accounting for EUR 100 billion. This chapter presents the classification and give some examples of MD in EU and describes and analyzes all safety alerts on MD of a member state of EU in 2017. International laws were used to define MD. Examples and safety alerts of MD of the Portuguese medicine agency were considered. MD are not medicines, but they have a medicinal application. MD are classified in Classes I-III. Only 32 safety alerts were identified in Portugal, none related to serious adverse events, and 6 related to devices voluntarily withdrawal from the market, for example, counterfeit products. The concept of MD is clearly defined in regulations. Although alerts on MD are limited, falsified products were identified in EU market, which is extremely regulated. For instance, future development of safety, traceable, and economic devices is very important to assure, patients' safety and access.

Unmaking Democratic Europe

2020 ◽  
pp. 294-312
Author(s):  
Martin Conway
Keyword(s):  
Twentieth Century ◽  
European Union ◽  
Large Degree ◽  
Global Capitalism ◽  
The Other ◽  
Democratic Politics ◽  
The European Union ◽  
Institutional Structures ◽  
Post War ◽  
First Time

This concluding chapter describes how the Europe of the 1990s was for the first time in its history both united and democratic. But the sudden turning point of 1989 lacked something of the global significance of the other European post-war moments of the twentieth century in 1918 and 1945. Europe no longer stood at the centre of its own history, as demonstrated by the ineffective response of the European Union to the violent disintegration of Yugoslavia during the 1990s, and by the divisions that emerged among European states during the American-led wars in Iraq and Afghanistan. In economic terms, too, the ascendancy of a new global capitalism obliged Europe to accept the economic weather generated by more distant or universal forces. In addition, however, Europe had lost confidence in the democratic model that it had developed and, to a large degree, patented. The more fractured and fluid politics that had emerged in Europe by the end of the twentieth century might be more appropriately described as post-democracy: a politics still conducted through the language and institutional structures of democracy, but which lacked much of the former substance of democratic politics.

scholarly journals Regulating drugs, medical devices, and diagnostic tests in the European Union: early lessons from the COVID-19 pandemic?

2020 ◽  
Vol 41 (23) ◽  
pp. 2140-2144 ◽  
Author(s):  
Alan G Fraser ◽  
Piotr Szymański ◽  
Elizabeth Macintyre ◽  
Martin Landray
Keyword(s):  
European Union ◽  
Medical Devices ◽  
Diagnostic Tests ◽  
The European Union

scholarly journals Measles Induced Death in Eastеrn Europe

2014 ◽  
Vol 41 (2) ◽  
pp. 80-87
Author(s):  
Ju. Ananiev ◽  
Iv. Vassilev ◽  
G. Arabadjiev ◽  
V. Ramdan ◽  
A. Chokoeva ◽  
...  
Keyword(s):  
European Union ◽  
Bacterial Infections ◽  
Clinical Symptoms ◽  
Fatal Outcome ◽  
Medical Personnel ◽  
Medical Intervention ◽  
The European Union ◽  
Irreversible Damage ◽  
Standard Type ◽  
Roma Population

Summary The infectious disease of measles is becoming a rarity in the member states of the European Union. After the implementation of the mandatory immunization calendar, cases of measles among children rarely encounter while those that have been registered usually pass lightly and without any significant complications. We present two cases of a measles-type infection with a fatal outcome for two children - 4 and 11 years of age respectively - who had not been immunized by the time of the event and who developed an unfolding clinical picture with the respective complications. In a number of countries in the European Union (as well as within some ethnical groups, the Roma population included), standard-type vaccinations may appear to be problematic. The most frequently encountered complications, resulting from such “blunders”, are pneumonia and encephalitis but controlling the clinical symptoms is not always possible because of: 1) late medical intervention due to the poor knowledge ability of the respective ethnical group (overdue contact with the specialized medical personnel), as well as 2) the superposed bacterial infections which unmask the initial diagnosis. Obtaining a clear picture of the symptoms in such patients is difficult. In the rare cases, when the therapy is rewarded with some success, patients remain partial or permanent invalids because of the irreversible damage to the brain and/or the functions of the lungs.

The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

2019 ◽  
pp. 216847901987073 ◽  
Author(s):  
Beata Wilkinson ◽  
Robert van Boxtel
Keyword(s):  
European Union ◽  
Medical Device ◽  
Clinical Evaluation ◽  
Medical Devices ◽  
Real World ◽  
The European Union ◽  
Clinical Investigations ◽  
Clinical Benefits ◽  
The Eu ◽  
Medical Device Regulation

This article comments on the new approach to the clinical evaluation of medical devices in the European Union (EU), which adds consideration of intended clinical benefits to the traditional focus on safety and performance. The article also discusses types of clinical benefits that may be claimed and how evidence for them may be generated. In the EU, determining the benefit-risk profile is an existing core requirement of the clinical evaluation performed according to MEDDEV 2.7/1 Rev 4 guidelines, but under the new Medical Device Regulation (MDR), “intended” clinical benefits must be determined first. The MDR sets high standards for ensuring reliable data are generated from clinical investigations. It stipulates that the endpoints of clinical investigations should include clinical benefits. However, many clinical-use questions arise only after a device is made widely available to patients. For all medical devices, particularly for on-the-market devices never subjected to randomized controlled trials and for new devices developed when these trials were inappropriate/impossible, the postmarket phase of the device is a valuable source of clinical-benefit data. Postmarket clinical follow-up can corroborate and refine predictions of clinical benefits over time. Indirect clinical effects, which may affect treatment adherence and influence patients’ well-being, may surface in the postmarket phase. Real-world clinical data will improve the manufacturer’s understanding of their device’s clinical benefits, potentially changing claims of intended clinical benefits in subsequent clinical evaluations. A paradigm change in clinical evaluation of medical devices in the EU will ensue when manufacturers ensure that their devices deliver real-world clinical benefits.

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