scholarly journals Hand Sanitizer: Regulatory Perspective in Different Countries

2021 ◽  
Vol 71 (2) ◽  
Author(s):  
Shivali Rahi ◽  
Ajay Kumar ◽  
Arpana Rana
Keyword(s):  
Marketing Authorization ◽  
Hand Sanitizer ◽  
Regulatory Authorities ◽  
Regulatory Perspective ◽  
Set Up ◽  
Business Sectors

Considering the new Coronavirus pandemic, the interest for antimicrobial products, for example, sanitizers and hand sanitizers are soaring. Regulatory authorities are performing their function by giving approvals to hand sanitizers in various countries through various regulations and marketing authorization procedures. The point of this article is to help in understanding the administrative prerequisites expected to bring the hand sanitizers or sanitizer items into various business sectors, just as the current administrative exceptions and interval gauges set up to help react to COVID-19.

scholarly journals Preparation of alcohol-based handrub in COVID-19 Alsatian cluster

2020 ◽  
Vol 5 (1) ◽  
Author(s):  
Elodie Di-Falco ◽  
Johan Bourbon ◽  
Isalyne Sbaffe ◽  
Jean-Daniel Kaiser
Keyword(s):  
Critical Period ◽  
Hospital Management ◽  
Management Team ◽  
The Other ◽  
Packaging Materials ◽  
Local Production ◽  
Technical Grade ◽  
Hand Sanitizer ◽  
Set Up ◽  
Real Challenge

AbstractAlsace, in particular Haut-Rhin, is one of the main clusters of COVID-19 in France. There has been a shortage of essential supplies in the area, especially alcohol-based hand sanitizer. In this context, and in accordance with the decree dated March 6, 2020, our hospital management team asked us to start local production of alcohol-based handrub. This was a real challenge: In one week, we had to implement the production of handrub to meet the needs of a 1,400-bed hospital. The production had to comply with the French preparation guidelines and take place on specific premises, with qualified and calibrated equipment, by qualified staff, under the supervision of a pharmacist. The other big challenge we faced was the supply of pharmaceutical raw and packaging materials. During this particular critical period, all suppliers were out of stock. Here, we describe the organizational set-up and the decisions made, e. g., to use technical-grade ethanol before the publication of the decrees dated March 13 and March 23, 2020.

scholarly journals Digital Transformation vs COVID-19: the Case of Japan

2020 ◽  
Vol 1 (2) ◽  
pp. 8-16 ◽  
Author(s):  
Junzo Iida
Keyword(s):  
Japanese Society ◽  
Digital Transformation ◽  
Government Agencies ◽  
The Past ◽  
Electronic Contracts ◽  
Court Proceedings ◽  
The Government ◽  
Set Up ◽  
Second Wave ◽  
Business Sectors

Whilst the DX policy of the Japanese government started in 2001, then called the E-Japan Strategy and being replaced a few years later by the i-Japan Strategy, in the 20 years since then IT has not been a success in Japan’s administrative system. On the other hand, the private sector, concerned about Japan’s lagging in its adoption of information technology, has been gradually moving forward to DX measures, such as electronic contracts. Then, this year, the COVID-19 pandemic broke out. Japan is (as of July 2020) about to experience a second wave of this disease. The need for DX has become imperative in all aspects of Japanese society, especially the government and business sectors. In the first half of 2020, the government set up DX policy rapidly; for example, civil court proceedings, the traditional carve seals custom, and the submission of administrative documents to government agencies have also been forced to move forward to DX due to COVID-19. It might be said that the crisis has been the catalyst for Japan’s shift to DX. However, it will be at least a few years before it can be known whether Japan’s DX will succeed, looking at the past examples within the Japanese bureaucratic system and politicians’ attitudes towards DX.

scholarly journals Efficacy, Safety, and Economics of Innovative Medicines: The Role of Multi-Criteria Decision Analysis and Managed Entry Agreements in Practice and Policy

2021 ◽  
Vol 3 ◽  
Author(s):  
Tanja Fens ◽  
Eugène P. van Puijenbroek ◽  
Maarten J. Postma
Keyword(s):  
Decision Analysis ◽  
Safety Data ◽  
Evidence Base ◽  
Point Of View ◽  
Marketing Authorization ◽  
Multi Criteria Decision Analysis ◽  
Regulatory Bodies ◽  
Managed Entry Agreements ◽  
Set Up

Through the years, solutions for accelerated access to innovative treatments are implemented in models of regulatory approvals, yet with limited data. Besides efficacy data, providing adequate safety data is key to transferring conditional marketing authorization to final marketing authorization. However, this remains a challenge because of the restricted availability and transferability of such data. Within this study, we set up a challenge to analyze the answers of two questions. First, from regulatory bodies' point of view, we bring the question of whether multi-criteria decision analysis (MCDA) is an adequate tool for further improvement of health technology assessment (HTA) of innovative medicines. Second, we ask if managed entry agreements (MEAs) pose solutions for facilitating the access to innovative medicines and further strengthening the evidence base concerning efficacy and effectiveness, as well as safety. Elaborating on such challenges brought us to conclude that increasing the attention to safety in MCDAs and MEAs will increase the trust of the authorities and improve the access for the manufacturers and the early availability of safe and effective medicines for the patients.

The Regulatory Management in the Energy and Electronic Communications Sectors: Towards Institutional Convergence?

2005 ◽  
Vol 23 (1) ◽  
pp. 87-97
Author(s):  
Stefano da Empoli
Keyword(s):  
Institutional Design ◽  
Electronic Communications ◽  
Regulatory Authorities ◽  
Italian Case ◽  
Eu Directives ◽  
Institutional Convergence ◽  
Parallel Pattern ◽  
Set Up ◽  
Two Sectors ◽  
Regulatory Management

Abstract Regulatory authorities in the energy and electronic communications sectors have followed a parallel pattern due to the liberalization process that has interested the two sectors during the last decade in Europe. The reason can be partly traced back to a same legislative origin (EU directives promoted by the European Commission). In some European countries, a single authority is envisioned as a conclusion to such a common institutional path. This article inquires if institutional convergence may be justified by similar regulatory needs. Based on several critical factors, it is argued, however, that a different institutional design for the two regulatory authorities would be a more efficient solution.These findings are then applied to the Italian case, where the Energy Authority (AEEG) and the Communications Authority (AGCOM) were set up during the late 90s. In this case, no particular convergence can be found. However, differences reflect a heavily inefficient institutional design.

India: Similar biologics guidelines and implementation

2012 ◽  
Vol 9 (4) ◽  
pp. 181-186 ◽  
Author(s):  
Smita Suneel Singhania ◽  
Krishan Kumar Tripathi
Keyword(s):  
Task Force ◽  
Marketing Authorization ◽  
Guidance Document ◽  
Regulatory Pathway ◽  
Regulatory Authorities

Indian regulatory authorities for biologics, jointly at Department of Biotechnology and Central Drug Standard Control organization in association with the task force comprising Indian biologics manufacturers laid down the regulatory pathway for manufacturing and marketing authorization of similar biologics, claiming to be similar to an already authorized reference biologic. This guidance has come in force from 15 September 2012 in India. This guidance document is a simple abridged process for evaluation of ‘Similar Biologics’ that are approved and marketed either in India, Europe or USA or any other country for more than 4 years.

The Effects of Drying Techniques on Clay-Rich Soil Texture

1974 ◽  
Vol 32 ◽  
pp. 466-467
Author(s):  
T. G. Naymik
Keyword(s):  
Critical Point ◽  
Liquid Nitrogen ◽  
Liquid Nitrogen Temperature ◽  
Drying Methods ◽  
Air Drying ◽  
Freeze Dried ◽  
Critical Point Drying ◽  
Set Up ◽  
The Relationship ◽  
Quartz Grains

Three techniques were incorporated for drying clay-rich specimens: air-drying, freeze-drying and critical point drying. In air-drying, the specimens were set out for several days to dry or were placed in an oven (80°F) for several hours. The freeze-dried specimens were frozen by immersion in liquid nitrogen or in isopentane at near liquid nitrogen temperature and then were immediately placed in the freeze-dry vacuum chamber. The critical point specimens were molded in agar immediately after sampling. When the agar had set up the dehydration series, water-alcohol-amyl acetate-CO2 was carried out. The objectives were to compare the fabric plasmas (clays and precipitates), fabricskeletons (quartz grains) and the relationship between them for each drying technique. The three drying methods are not only applicable to the study of treated soils, but can be incorporated into all SEM clay soil studies.

Evaluation of Freezing Methods by Low Temperature X-Ray Diffraction

1977 ◽  
Vol 35 ◽  
pp. 330-333
Author(s):  
T. Gulik-Krzywicki ◽  
M.J. Costello
Keyword(s):  
Biological Materials ◽  
Molecular Organization ◽  
X Ray Diffraction ◽  
Glass Capillary ◽  
X Ray ◽  
Rate Dependent ◽  
Before And After ◽  
Freeze Etching ◽  
Diffraction Patterns ◽  
Set Up

Freeze-etching electron microscopy is currently one of the best methods for studying molecular organization of biological materials. Its application, however, is still limited by our imprecise knowledge about the perturbations of the original organization which may occur during quenching and fracturing of the samples and during the replication of fractured surfaces. Although it is well known that the preservation of the molecular organization of biological materials is critically dependent on the rate of freezing of the samples, little information is presently available concerning the nature and the extent of freezing-rate dependent perturbations of the original organizations. In order to obtain this information, we have developed a method based on the comparison of x-ray diffraction patterns of samples before and after freezing, prior to fracturing and replication.Our experimental set-up is shown in Fig. 1. The sample to be quenched is placed on its holder which is then mounted on a small metal holder (O) fixed on a glass capillary (p), whose position is controlled by a micromanipulator.

Eels Under Standing Wave Conditions

1982 ◽  
Vol 40 ◽  
pp. 492-495
Author(s):  
O.L. Krivanek ◽  
J. TaftØ
Keyword(s):  
Standing Wave ◽  
Wave Conditions ◽  
Set Up ◽  
A Site ◽  
Complex Crystal

It is well known that a standing electron wavefield can be set up in a crystal such that its intensity peaks at the atomic sites or between the sites or in the case of more complex crystal, at one or another type of a site. The effect is usually referred to as channelling but this term is not entirely appropriate; by analogy with the more established particle channelling, electrons would have to be described as channelling either through the channels or through the channel walls, depending on the diffraction conditions.

Low-Loss Images in a Stem/Tem Microscope

1976 ◽  
Vol 34 ◽  
pp. 496-497 ◽  
Author(s):  
David C. Joy ◽  
Dennis M. Maher
Keyword(s):  
High Resolution ◽  
Surface Topography ◽  
Beam Direction ◽  
Low Loss ◽  
Specimen Holder ◽  
Glancing Angle ◽  
High Resolution Images ◽  
Set Up ◽  
Conventional Manner ◽  
Objective Type

High-resolution images of the surface topography of solid specimens can be obtained using the low-loss technique of Wells. If the specimen is placed inside a lens of the condenser/objective type, then it has been shown that the lens itself can be used to collect and filter the low-loss electrons. Since the probeforming lenses in TEM instruments fitted with scanning attachments are of this type, low-loss imaging should be possible.High-resolution, low-loss images have been obtained in a JEOL JEM 100B fitted with a scanning attachment and a thermal, fieldemission gun. No modifications were made to the instrument, but a wedge-shaped, specimen holder was made to fit the side-entry, goniometer stage. Thus the specimen is oriented initially at a glancing angle of about 30° to the beam direction. The instrument is set up in the conventional manner for STEM operation with all the lenses, including the projector, excited.

Sign in / Sign up

Export Citation Format

Share Document