Search results for "Authorization"
showing 10 items of 32 documents
Assessment of genetically modified maize GA21 for renewal of authorisation under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐RX‐005)
2017
Efsa Panel On Genetically Modified Organisms (gmo) Requestor: European Commission (DG SANTE)Question number: EFSA-Q-2016-00714Correspondence; Following the submission of application EFSA-GMO-RX-005 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application of the herbicide-tolerant genetically modified maize GA21. The data received in the context of this renewal application contained post-market environmental monitoring reports, a systematic search and eval…
Myotonic dystrophy type 1 drug development: A pipeline toward the market
2021
Highlights • Myotonic dystrophy, a neuromuscular disease, affects at least around half a million people worldwide. • Close to two dozen preclinical and clinical drug development programs active. • Drugs encompass new chemical entities, repurposing, oligonucleotide, and gene therapy. • Tideglusib, mexiletine, and metformin are close to reaching marketing authorization.
Scientific Opinion on application EFSA‐GMO‐BE‐2013‐118 for authorisation of genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 591…
2017
Abstract In this opinion, the GMO Panel assessed the five‐event stack maize MON 87427 × MON 89034 ×1507 × MON 88017 × 59122 and its 25 subcombinations, independently of their origin. The GMO Panel has previously assessed the five single events combined to produce this five‐event stack maize and 11 subcombinations of these events and did not identify safety concerns. No new data on the single events or their previously assessed subcombinations, leading to modification of the original conclusions were identified. The combination of the single events and of the newly expressed proteins in the five‐event stack maize did not give rise to issues – based on the molecular, agronomic/phenotypic or c…
Trends in individual reimbursement of orphan drugs in Latvia in 2008–2011
2014
Orphan drugs (ODs) are medicinal products intended for diagnosis, prevention or treatment of life-threatening or very serious diseases affecting less than 5 in 10 000 people in the European Union (EU). These drugs are called “orphans” because the pharmaceutical industry has little interest, under normal market conditions, in developing and marketing products intended for only a small number of patients suffering from very rare conditions. Because of the small market, ODs are often very expensive. Whereas decisions surrounding orphan designation and marketing authorization of ODs are taken at the EU level, decisions governing pricing and reimbursement of ODs are a member state responsibility…
Analyzing the security of Windows 7 and Linux for cloud computing
2013
We review and analyze the major security features and concerns in deploying modern commodity operating systems such as Windows 7 and Linux 2.6.38 in a cloud computing environment. We identify the security weaknesses and open challenges of these two operating systems when deployed in the cloud environment. In particular, we examine and compare various operating system security features which are critical in providing a secure cloud. These security features include authentication, authorization and access control, physical memory protection, privacy and encryption of stored data, network access and firewalling capabilities, and virtual memory.
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.
The Polyphonic Theology of the Church Fathers
2014
Prof. Dr. Dres. H. c. Christoph Marschies (Humboldt University Berlin, Germany) in collaboration with Prof. Dr. Michael Welker (Heidelberg University, Germany) initiated an international project to which about 25 international scholars of high profile were invited to participate. The purpose of the project is to gain a new and nuanced perspective on the theology of 19 church fathers: Justin the Martyr, Irenaeus of Lyon, Tertullian, Origen, Cyprian, Eusebius, Athanasius of Alexandria, Basil the Great, Gregory of Nazianzus, Gregory of Nyssa, John Chrysostom, Augustine, Cyril of Alexandria, Leo the Great, Theodoret of Cyrus, Boethius, Isidore, Maximus the Confessor and John Damascene. Research…
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 …
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 …
Autorizzazioni amministrative e liberalizzazione dei mercati tra diritto europeo e diritto interno
2018
Il libro ripercorre le trasformazioni della disciplina nazionale delle autorizzazioni amministrative per l'influenza del diritto dell'Unione europea che ha profondamente modificato la base giuridica del potere autorizzatorio. Dopo un'ampia premessa dedicata all'affermazione delle politiche di liberalizzazione in Europa, un'ampia parte del lavoro è rivolta ad esaminare i nuovi principi in materia di procedimenti autorizzatori che si possono ricavare dalla giurisprudenza della Corte di giustizia e dalla normativa europea. Inoltre, sono analizzati i cambiamenti che hanno riguardato i diversi settori nazionali in cui trovano applicazione le autorizzazioni amministrative, per dimostrare la progr…