Centralisation

Figure 11.4 Centralised versus remote production testing...

First we will look at the constraints in the above groupings, but they are most effectively managed In an Integrated approach, since they all act simultaneously on the profitability of the producing field. This requires careful planning and control by a centralised, integrated team, which will also be discussed. 

Quite generally, each sensitive spectiometric approach today requires instruments of rapidly escalating cost, and these have to be centralised for numerous users, with resident experts on tap. The experts, however, often prefer to devote themselves to improving the instruments and the methods of interpretation so there is a permanent tension between those who want answers from the instruments and those who have it in their power to deliver those answers. 

The final legal instrument is a Decision. A decision focuses on an individual measure and is directly binding in its entirety on the specific individuals or entities to whom it is addressed. The Commission uses Decisions to issue marketing authorisations for approval of new drugs granted under a centralised procedure (see Chapter 6). Figure 1.2 summarises the relationship between various legal instruments used in Europe. 

The pharmaceutical unit is the more active of the units as there is much greater use of EU-centralised procedures in drug regulation compared to devices. However, the activities of both units can be broken down under four main headings legislation support and guidance external relations and information technology. 

Evaluation of applications for drug marketing authorisations made either directly to the national authority or indirectly via the centralised procedure to the EMEA... 

Figure 6.14 Human medicinal products that may be authorised via the centralised procedure.

The decentralised procedure can be used in cases where the product has never been authorised in any of the Member States, and the applicant wishes to obtain a license in a number of states simultaneously. The applicant must submit applications with the complete dossier to the Competent Authorities of each of the Member States where authorisation is desired. A single Member State should be chosen as the reference state to undertake the scientific assessment ofthe complete dossier, while the other states are designated as concerned states. The review process has many parallels vhth the centralised procedure, in that similar time lines exist, the reference State plays the role ofthe rapporteur, and the concerned States replace the CHMP. Once all States have validated that the dossiers are complete, the reference State is allowed 70 days to review the dossier and prepare a preliminary assessment report, which is circulated to the concerned Member States and the applicant. Comments from the concerned Member States and applicant responses are collected so that by day 120 the reference State may issue a draft assessment report together vhth draft SPC, label and leaflet texts. The clock may be stopped until requested responses from the applicant are received. The application then enters the second step in the assessment process, during which all the concerned Member States consider the... 

The review of MRL applications is similar to that for centralised marketing authorisations conducted by the EMEA, in that rapporteurs are responsible for the hands-on evaluation, which is then reported back to the CVMP for consideration. If there are outstanding issues, a list of questions is forwarded to the applicant for his or her response. Otherwise, a formal opinion is prepared and presented to the Commission for legal implementation as a decision. The maximum time allowed to deliver a CVM P opinion is 120 days, excluding the time taken for an initial validation of the application and review of responses form the applicant where necessary. 

The procedures and timelines for obtaining marketing authorisations for veterinary products are essentially the same as those for human medicines. Extensive guidance can be found in The Rules Governing Medicinal Products in the European Union, Volume 6 - Notice to Applicants, Veterinary Medicinal Products. The products that may follow centralised procedures and receive Community authorisations are shown in Eigure 7.5. All other products must obtain authorisations from national... 

MedWatch A centralised MedWatch programme is provided to encourage the voluntary reporting of adverse drug reaction(s) by the medical profession. 

The storage is linked to a local district heating and cooling system that serves a newly established residential area in Vastra Hamnen (West Harbour) in the city of Malmo (Figure 87). The storage is an essential part of the system that also contains a centralised heat pump and chiller system. Electricity to run the system is obtained from a windmill. 

In practice, the injected solute will occupy a finite volume, and the injection may not be properly centralised either. Both of these have the effect of making dc greater, or L smaller, for infinite diameter behaviour, than the values calculated from Eq. 2.3e. If these effects are allowed for, it can be shown that columns of 25 cm or less, with injections of 10 fil or less, show infinite diameter behaviour when their diameters are greater then about 4 mm. 

This is an abstract model of the state of the whole System, and says nothing about its construction — whether it is distributed or centralised, whether the links are database keys or pointers, whether the types can be found in the implementation as individual classes. These matters are all left to the design phase a distributed object implementation, or a server-based one with remote screen-control clients would both be equally valid choices. 

How do different geographical demand scenarios and hydrogen introduction strategies affect the choice of production technology, production structure (centralised vs. decentralised production) and means of transportation (trailer or pipeline) ... 

The use of hydrogen for electric energy production from fossil fuels in large centralised plants will contribute positively to achieve important reductions of C02... 

Using hydrogen to produce electrical energy from fossil fuels in large centralised plants will contribute positively to achieving important reductions of C02 emissions, if this is combined with C02 capture and sequestration processes. Such plants will also help to increase the diversification of resources, since a variety of fossil feedstocks can be used, including resources such as coal and waste that otherwise cause major impacts on the environment, as well as biomass. 

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