scholarly journals Guideline on current good radiopharmacy practice (cGRPP) for the small-scale preparation of radiopharmaceuticals

2021 ◽  
Vol 6 (1) ◽  
Author(s):  
Nic Gillings ◽  
Olaug Hjelstuen ◽  
Jim Ballinger ◽  
Martin Behe ◽  
Clemens Decristoforo ◽  
...  

AbstractThis guideline on current good radiopharmacy practice (cGRPP) for small-scale preparation of radiopharmaceuticals represents the view of the Radiopharmacy Committee of the European Association of Nuclear Medicine (EANM). The guideline is laid out in the format of the EU Good Manufacturing Practice (GMP) guidelines as defined in EudraLex volume 4. It is intended for non-commercial sites such as hospital radiopharmacies, nuclear medicine departments, research PET centres and in general any healthcare establishments. In the first section, general aspects which are applicable to all levels of operations are discussed. The second section discusses the preparation of small-scale radiopharmaceuticals (SSRP) using licensed generators and kits. Finally, the third section goes into the more complex preparation of SSRP from non-licensed starting materials, often requiring a purification step and sterile filtration. The intention is that the guideline will assist radiopharmacies in the preparation of diagnostic and therapeutic SSRP’s safe for human administration.

Author(s):  
Faruk Jayanto Kelutur ◽  
Holis Abdul Holik

A B S T R A C TTechnetium-99m ( 99m Tc) has been applied in nuclear medicine as a radiopharmacyfor both diagnosis and therapy. 99m Tc is obtained from a 99 Mo/ 99m Tc (half-life 66 h)generator in the form of sodium pertechnetate (Na[ 99m TcO 4 ]) by decaying to 99 Tc for 6hours and emitting gamma energy rays (Eɤ = 140 keV). This radionuclide has anelectron configuration of 4d 5 5s 2 , which will form complexes with different ligandsand have oxidation rates from +1 to +7. The coordinated complex of technetium-99mhas been utilized in nuclear medicine in tissues and organs (thyroid, red and whiteblood cells, kidneys, brain, myocardial, and bone). The resulting kit production musthave based on Good Manufacturing Practice, which consists of batch planning,washing, sterilization of glassware and stopper, starting material, preparation oflarge quantities of the solution, sterile filtration, dispensing, crimping, a summary ofprocess control, quarantine, packaging and leaving the production premises.


2021 ◽  
Vol 13 (13) ◽  
pp. 7393
Author(s):  
Agata Nicolosi ◽  
Donatella Di Gregorio ◽  
Giuseppe Arena ◽  
Valentina Rosa Laganà ◽  
Donatella Privitera

The study looks at the problems facing coastal fishing communities. It highlights the impacts that, in the complex framework of the EU reforms, have manifested themselves on economic activities and on society. The aim of the paper is twofold: to examine small-scale artisanal fishing in an area of Southern Italy in order to develop resilience and diversification and at the same time to outline the profiles of local bluefish buyers to highlight development strategies for the sector. The research carried out through a direct survey by administering a questionnaire to fishermen operating in areas of Southern Italy and the data cross-referenced with the opinions of local consumers. A conjoint experiment, followed by a multiple correspondence analysis and cluster identification, was used to outline the profiles of local bluefish buyers. The results of the analysis reveal that the fish market and the restaurant sector are the main distribution channels preferred by fishermen. Furthermore, fishermen are very sensitive to environmental issues and are willing to collaborate and actively participate in the environmental protection of the sea. Consumers recognise the quality of local bluefish, and they implicitly perceive the sustainability of the method of capture. The results show the need to undertake synergistic actions for the fishing industry, capable of activating marketing strategies adequately to support, promote and develop the sector. The results of the study provide helpful information for food companies in order to better segment their market and target their consumers, as well as to effectively promote their product using brands, certifications and traceability.


Polar Record ◽  
2011 ◽  
Vol 48 (4) ◽  
pp. 361-371 ◽  
Author(s):  
Timo Koivurova ◽  
Kai Kokko ◽  
Sebastien Duyck ◽  
Nikolas Sellheim ◽  
Adam Stepien

ABSTRACTThe European Union's (EU's) intention of becoming a permanent observer in the Arctic Council and the reluctance of Arctic actors to grant it that status have made the union's aspirations in the Arctic the subject of a continuing debate. The discussion appears to be dominated by geographical considerations and the EU's gradually emerging Arctic policy. This article puts forward a different view of the EU's presence in the region, one drawing on an analysis of relevant EU competences. As a complex international actor, the EU has acquired a broad array of decision-making powers from its member states, powers that partly extend to Iceland and Norway via the EEA Agreement. Moreover, the EU has in many cases become a relevant actor in international negotiations and treaty making processes the outcomes of which are of crucial importance for the governance of the Arctic. Our argument in the third and concluding section is that only by including the EU in Arctic governance can the international community provide better prospects for the union to sensitise its policies and discourses to the Arctic realities and for other Arctic actors to understand how the union functions. This argument is supported by an analysis of the EU's restrictions on the import of seal products and the ensuing litigation.


2021 ◽  
Vol 45 (1) ◽  
pp. 48-63
Author(s):  
Panagiotis Liargovas ◽  
Nikolaos Apostolopoulos

Abstract The focus of this article is on the main aspects of economic governance in Greece during the period 2015–19 where the syriza-anel coalition party was in power. In August 2015, the syriza-anel government faced the dilemma either to accept a new agreement with the EU partners (as eventually happened) or go bankrupt and leave the Eurozone, becoming detached from EU solidarity mechanisms. A third program was agreed, offering Greece an additional €86 billion loan over a three-year period. The third programme was unnecessary considering that the syriza-anel governance inherited 0.8% growth rate and some progress in the structural reforms demanded during the first two agreements in 2010 and 2011. However, the political choices made had the consequence of Greece returning to recession in 2015 and 2016.


2017 ◽  
Vol 18 (7) ◽  
pp. 1617-1640 ◽  
Author(s):  
Pietro Faraguna

This Article consists of five sections. In the first section, it describes why identity questions matter, particularly in Europe. In the second section, the Article tackles the issue of multiple structural ambiguities affecting the concept of constitutional identity in the European constitutional vocabulary. In the third section, the Article explores trends concerning the use of constitutional identity in the European legal discourse and practice, including the development of alternative interpretations and applications of the notion of constitutional identities in the Member States. The fourth section of the Article combines the analytical accounts outlined in the second section with the trends identified in the third section, contending that different conceptions and applications of constitutional identity have varying effects on the European composite constitutional adjudication system and that the institutional and procedural framework should be calibrated accordingly. The final section of this Article draws some conclusions.


2008 ◽  
Vol 17 (1) ◽  
pp. 31 ◽  
Author(s):  
N. VASILIEV ◽  
A. ASTOVER ◽  
M. MÕTTE

The aim of this study is to analyse the efficiency of Estonian grain farms after Estonia’s transition to a market economy and during the accession period to the European Union (EU). The non-parametric method Data Envelopment Analysis (DEA) was used to estimate the total technical, pure technical and scale efficiency of Estonian grain farms in 2000–2004. Mean total technical efficiency varied from 0.70 to 0.78. Of the grain farms 62% are operating under increasing returns to scale. Solely based on the DEA model it is not possible to determine optimum farm scale and the range of Estonian farm sizes operating efficiently is extensive. The most pure technically efficient farms were the smallest and the largest but the productivity of small farms is low compared to larger farms because of their small scale. Therefore, they are the least competitive. Since pre-accession period to the EU, large input slacks of capital have replaced the former excessive use of labour and land. This raises the question about the effects on efficiency of the EU’s investment support schemes in new member states.;


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