Meetings and recommendations

Outside of the regular planned meetings, details of all SAEs should be supplied to the DMC in real time and the DMC members should arrange to discuss these, by email or teleconference for example, as and when they feel necessary. 

Recommendations to the sponsor coming out of the regular DMC meetings will be one of the following  

Clearly if the recommendation is anything other than continue unchanged then additional information would need to be supplied to support these recommendations. The recommendations are not binding on the sponsor, although as mentioned earlier it would be very unusual to see these recommendations being ignored. 

This was a multi-centre, pan-European, randomised double-blind placebo-controlled clinical trial in acute stroke to evaluate the effect of ancrod, a natural defribrinogenating agent (Hennerici et al. (2006)). The primary endpoint was based on the Barthel Index a favourable score of 95 or 100 or a return to the pre-stroke level at three months was viewed as a success. The primary method of statistical analysis was based on a logistic model including terms for treatment, age category, baseline Scandinavian Stroke Scale and centre. 

The proposed sample size was 600 patients and two interims were planned after 200 and 400 patients (completing 3 months follow-up) using the O Brien and Fleming scheme with adjusted two-sided significance levels of 0.00052, 0.014 and 0.045. A futility rule was also introduced, based on conditional power (under the current trend) being below 30 per cent for the trial to be stopped. 

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Chaignat CL, Monti V (2007) Use of oral cholera vaccine in complex emergencies What next Summary report of an expert meeting and recommendations of WHO. J Health Pop Nutr 25(2) 244-261... 

Although ASTM specifies certain quaUty levels, there are a number of factors that contribute to other quaUty levels in the marketplace. At times, government regulations are more restrictive than ASTM specifications, especiaHy with respect to environmental issues. Secondly, competitive forces may encourage companies to provide fuel quaUty that is better than that defined by ASTM. Thirdly, ASTM specifications do not have the force of law, and certain companies may decide to exceed or not meet their recommended values. In response to this last factor, some states have adopted ASTM fuel quahty specifications as state regulations, thus forcing a minimum quaUty level in the field. 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

Conduct customer focus meetings to gather opinion and recommendations for action, using data gathered from questionnaires and periodic customer feedback. 

As an alternative option, the insulation should meet the recommendations of BS 5422 1977. This Standard tabulates thicknesses of insulation too numerous to mention here, according to whether (1) the pipes carry central heating or domestic hot water, (2) the system is heated by gas and oil or solid fuel, (3) the water temperature is 75°C, 100°C or 150°C and (4) the thermal conductivity of the insulant is 0.04, 0.55 or 0.70 W/mK at the appropriate mean temperature. 

The regulation states The report must be reviewed with all affected personnel whose job tasks are relevant to the incident findings, including contract employees where applicable. The aim of this clause is to ensure that all affected employees understand why the incident occurred and what actions could prevent a recurrence. While the regulation does not specifically define the methods to comply with this requirement, it is imperative that the review is prompt and complete. In almost all cases, the review requires personal meetings, either individually or in small groups, to thoroughly review the incident and recommend corrective actions. 

The NRC subcommittee s review of the AEGL reports prepared by NAC and its contractors involves oral and written presentations to the subcommittee by the authors of the reports. The NRC subcommittee provides advice and recommendations for revisions to ensure scientific validity and consistency with the NRC guideline reports (NRC 1993, in press). The revised reports are presented at subsequent meetings until the subcommittee is satisfied with the reviews. Because of the enormous amount of data presented in the AEGL reports, the NRC subcommittee can not verify all the data used by NAC. The NRC subcommittee relies on NAC for the accuracy and completeness of the toxicity data cited in the AEGLs reports. 

Anmunition Plant. In the analysis, the probability levels of Table VI were used as requirements, and recommendations for changes made to subsystems which did not meet these requirements. 

Book clubs are a great way to meet new friends or keep in touch with old ones, while keeping up on your reading and participating in lively and intellectually stimulating discussions. If you re interested in starting a book club, you should consider the following options and recommendations. 

The Environment Committee endorsed the MPD and recommended it to the Council for action at its May 1981 meeting. However, the Council, in the face of new U.S. opposition to enactment of the MPD as written, failed to enact either a Decision or a Recommendation concerning MPD. 

After the investigation is completed and the findings and recommendations are issued in the report, a system must be in place to implement those recommendations. This is not part of the investigation itself, but rather the follow-up related to it. It is not enough to put a technological, procedural, or administrative response into effect. The action should be monitored periodically for effectiveness and, where appropriate, modified to meet the intent of the original recommendation. 

SIDS initial assessment and agreement on conclusions on hazard and recommendations at SIDS Initial Assessment Meeting (SIAM)... 

The SIAR, which includes evaluations, conclusions, and recommendations and a SIDS Initial Assessment Profile (SlAP, see below), is discussed at the SIDS Initial Assessment Meeting (SIAM), resulting in an internationally agreed assessment for each chemical with agreed conclusions and recommendations. 

The SlAP is a 1-2 page executive summary of the SIAR, which summarizes the rationale for the conclusions and clarifies the recommendations further, if appropriate. The SlAP is used to transmit the conclusions and recommendations of the SIAM on a chemical to the Joint Meeting for... 

WHO can advise UNICH and other UN agencies whether vaccines and other medicines included in die prequaUfication scheme effectively meet WHO-recommended requirements only if die national regulatory audiority of die producing country exercises independent and appropriate oversight of die pharmaceuticals concerned, and if they have been adequately assessed by diat authority (WHO, 2002). 

In 2007, the DART committee held a workshop on alternative assays, which was followed up by a workshop held at the European Teratology Society Annual Meeting in 2009. These workshops focused on three alternative assays (1) whole embryo culture (WEC), (2) mouse embryonic stem cell tests (mESC), and (3) zebrafish. Each assay was presented and data from users were shared, and strengths and limitations were discussed. It should be noted that the WEC and mESC are validated by ECVAM as alternative embryotoxicity assays. Still, there are numerous research needs before even validated tests can achieve regulatory acceptance. The discussions, conclusions, and recommendations of the 2007 workshop were published by Chapin et al. (14). Bullet lists of next steps to move forward were defined for each assay (14) and are briefly summarized here ... 

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