Programme amending

The amendments shown in Table 2 above should not increase the amount of NDE applied in quality conscious yards and in some cases may give a reduction by eliminating the double checking that can sometimes occur. Other yards may find that a more extensive NDE programme will be required. The benefits obtained from an enhanced inspection scheme should be apparent in the improved fatigue life of the ships. 

Agreement on the NDE plan will be dependent on the extent and relevance of theschedule. Under the amendments proposed to the Rules Surveyors will check that structurally significant welds are included in the shipyard s quality control programme. When agreement has been reached the Surveyor will endorse the plan. 

Regulation amending Regulation 3600/92 on the implementation of the first stage of the programme... 

United Nations Environmental Programme (2009) Stockholm convention on persistent organic pollutants (POPs) as amended in 2009... 

The European Commission has bowed to government and industry pressure, and made a series of amendments to water down its proposed European Union chemical policy. Proposals to test polymers under the policy s Reach programme have been all but scrapped, and the number of intermediates requiring testing has been drastically reduced. The concessions mean that the number of chemicals to be tested under Reach has fallen from about 30,000 to about 10,000. Some polymers may have to be registered under the revised version of Reach, but only after a review of the risks they pose, and taking into account the impact on competitiveness, innovation and protection of human health and the environment. EUROPEAN COMMISSION... 

One of the measures of the quality of the preregistration clinical programme is the total time from the decision to enter full development to the first regulatory approval in a major market. It is also important to monitor quality in other ways. One option is to assess the frequency with which predetermined milestones are achieved. More subtly, quality can be assessed by examining the number of incomplete, inaccurate or indecipherable CRFs that are returned or the number of protocol amendments made which are not based on new information. Milestones may still be achieved when quality is poor, that is, when there is inefficiency, but this means that they were wrongly established and can be improved if efficiency improves. 

The FDA pace of implementation of the 1962 Amendments was, however, necessarily slow. The American Public Health Association therefore brought a lawsuit to require FDA to complete its DESI programme for pre-1962 new drugs. 

The IND evolves with the development programme. It is amended with each new protocol and with each meaningful change in an existing... 

COMMISSION REGULATION (EC) No 2032/2003 of4 November 2003 on the second phase ofthe 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, and amending Regulation (EC) No 1896/2000. Official Journal L 307 (24 November 2003), 1-96. 

Since the launch of its nuclear use and development programme, Japan has limited nuclear uses to peaceful purposes and has managed the programme under a strict domestic control system. In response to the ratification of the NPT in 1976, the government amended the Nuclear Regulation Law and set up a national system which enabled the country to cope with the IAEA s full scope safeguards. An outline of the system is shown in Fig. 11.2. 

Health Canada is the responsible Ministry for the enforcement of the Food and Drugs Act and for the formulation of and amendments to the Drugs Regulations. The former Drugs Directorate and the Medical Devices Bureau of the Health Protection Branch (HPB) have been combined to form a new agency, the Therapeutic Products Programme (TPP). 

The programmes shall be reviewed and updated regularly, at least every four years, in the light in particular of technical progress and of the economic and environmental situation. Amended programmes shall be communicated to the Commission in good time. 

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