Search results for "Authorization"
showing 10 items of 32 documents
Italian incentive strategy and regulations on small wind power turbines: A critical overview
2016
Small wind power industry in Italy had its kick-start in 2009, after the Government implemented two measures introducing both the simplified regime and incentive rates for small wind power plants. In the last six years, a lot of plants and small wind turbines have been installed in Italy, especially in the South. Aim of this paper is to examine how local standards, incentive policy and regulations have affected the spread of small wind turbines in Italy. After examining national and regional legislation, an analysis of the data on the penetration of wind systems in Italy has been carried out, with particular attention to six Southern regions (Basilicata, Calabria, Campania, Apulia, Sardinia…
Cell therapy medicinal product regulatory framework in Europe and its application for MSC-based therapy development
2012
Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundation…
Mutual entity authentication for LTE
2011
In this paper we outline the Authentication and Key Agreement protocol (EPS-AKA) found in Long-Term Evolution (LTE) systems. This architecture is the 3GPP version of a 4G access security architecture. The LTE security architecture is a mature evolved architecture, with both strengths and weaknesses. In this paper we propose an amendment to the EPS-AKA protocol to make it a full mutual (online) entity authentication protocol. We also analyze the proposal, highlighting both the improvements and the drawbacks of the new AKA protocol.
Regulatory evaluation of Glybera in Europe — two committees, one mission
2013
Representing the first gene therapy to be approved in the Western world, alipogene tiparvovec (Glybera; Uniqure) has recently been said to have had a “substantial impact from a regulatory perspective” (Nature Rev. Drug Discov. 11, 664; 2012) 1 . The therapy was granted marketing authorization in the European Union for the treatment of lipoprotein lipase deficiency, which results in a clinically heterogeneous condition with a risk of potentially life-threatening pancreatitis 2 , at the end of 2012. The decision followed a positive opinion by the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) 3
Zur Einberufung der Hauptversammlung durch die nach § 122 Abs. 3 AktG ermächtigte Aktionärsminderheit
2014
DeutschDie durch eine Aktionarsminderheit einberufene auserordentliche Hauptversammlung der Balda AG vom 18. 7. 2013 1 hat gezeigt, dass Rechtsstellung und Befugnisse der gerichtlich zur Einberufung ermachtigten Minderheit bislang wenig geklart sind. In besonderer Weise gilt dies fur die Frage, ob der einberufende Aktionar befugt ist, eine Anmeldestelle zu benennen, und in der Folge Aktionare, die sich innerhalb der Frist des § 123 Abs. 3 Satz 2 AktG unter der angegebenen Adresse anmelden, zur Teilnahme an der Hauptversammlung berechtigt sind. Der Beitrag bejaht diese Frage. EnglishUnder Section 122 Para. 3 of the German Stock Corporation Act, a court may authorise shareholders to call a sh…
Pharmacy and pharmacology of biosimilars
2008
Biosimilar medicines are biological medicinal products that can obtain a marketing authorization in the EU after the original product (biological reference medicine) has run out of patent. As a prerequisite, studies including clinical trials are to be conducted to compare the quality, safety, and efficacy of the biosimilar and reference medicine. Due to the specific characteristics of biopharmaceuticals like complex 3-dimensional (glyco) protein structure, immunogenicity, production in living organisms, which causes heterogeneity, complex manufacturing process and analysis, interchangeability of the biosimilar with its reference drug product is not guaranteed. In addition, INN (internationa…
Transformations in Lifelong Guidance Provision
2012
In this chapter, the transformations taking place at the different levels of guidance provision are analyzed. The aim was to provide a tool to examine the interface between multisectoral guidance practice and policy development. On the basis of earlier research on regional guidance networks, a model is introduced in which schools, social, health, and public employment services can jointly design, implement, and evaluate guidance services. The model for Networked Guidance Service Provision (NEGSEP) focuses separately on the developmental needs of guidance services visible to clients, both with regard to service delivery and strategic dimensions. Along this line, a framework for networked gui…
Monitoring resource consumption and anthropogenic substances in the EU and Latvia
2011
PurposeThe aim of this paper is to assess how the indicator sets presently used to monitor sustainable development in the European Union (EU) and Latvia reflect resource consumption and the production and use of anthropogenic substances.Design/methodology/approachThe study was conducted by analyzing different sources as well as statistical information on development character in Latvia and human impact at first in respect to use of chemicals.FindingsMany of the analyzed sustainable development indicators related to resource consumption interpret a reduction in consumption as a negative phenomena and thus contradictory to sustainability. The only relevant EU and Latvian indicator related to …
A novel scheme for privacy preserving in RBAC
2013
Role Based Access Control (RBAC) Model has been proved to be quite useful and has drawn a lot of research interest over the last fifteen years. In this paper we discuss general context-aware RBAC model. We analyze potential privacy threats associated with use of context-aware RBAC and propose a novel scheme that provides privacy-preserving for access models based on RBAC.
Manufacturing, characterization and control of cell-based medicinal products: challenging paradigms toward commercial use
2015
During the past decade, a large number of cell-based medicinal products have been tested in clinical trials for the treatment of various diseases and tissue defects. However, licensed products and those approaching marketing authorization are still few. One major area of challenge is the manufacturing and quality development of these complex products, for which significant manipulation of cells might be required. While the paradigms of quality, safety and efficacy must apply also to these innovative products, their demonstration may be demanding. Demonstration of comparability between production processes and batches may be difficult for cell-based medicinal products. Thus, the development …