Strategy. As an organization without operational services (fuel, maintenance, etc.), and in consideration that the majority of potential issues come from boat maintenance whereby the boats are personal property, the predominant strategy will be the minimization of on-site waste. With this approach, the organization will have minimal potential impact on the environment and reduce regulatory risk. To accomplish this, requirements will be established by policy, periodic communications shall occur, and audits will be utilized to provide feedback for improvement.
Strategy. The strategy is to complete a minimal additional amount of preclinical safety in parallel with the clinical development program. [**]. The filing will be based on a [**]. We note that the current phase 2 study has no control group, and can give only general information about safety and tolerability, and no real information on efficacy in humans. For this reason the [**] will be designed with a ‘vanguard’ cohort of approximately [**] patients. Once the vanguard has completed 6 months of follow up, and interim analysis will be performed, assessing the study for 1) safety, 2) efficacy or futility and 3) performance of the endpoint. Specific, detailed and comprehensive criteria will be established to allow for stopping or continuation, or adjustments in sample size or inclusion criteria. The rules for the interim analysis will be agreed with regulatory authorities in advance of any unblinding, and appropriate adjustments will be made for type 1 error. Following the interim analysis the number of participating centers will be increased to speed enrollment, and the study will continue to completion. Endpoint and sample size We will define [**] and then power the study to show at least a [**] with BL-1040 compared to placebo. This difference is clinically meaningful. To give maximum power we want to define an endpoint that has a [**] after treatment, which would be reduced to [**]. We will design a [**] that ensures an event rate that is [**] in the control arm. Failure could include [**] Any one of these events and the patient is [**]; none of these events and the patient is considered [**]. It is possible that other clinically relevant events may be added to the composite. Next we will estimate how often each of these events will happen. [**]. Control Group Event Rate Treatment Group Event Rate Sample size per arm 90% power and type 1 error < 5% Total [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] Although not required under device approval regulations, approximately [**] patients would be desirable for a safety database. If we assume that the placebo event rate will be approximately [**], we would estimate the sample size of the pivotal study to be approximately [**] patients, including the [**] patients in the vanguard cohort. Budget 2009 2010 2011 2012 2013 2014 2015 2016 TOTAL [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] TOTAL [**] [**] [**] [**] [**] [**] [**] [**] [**] Phase III Study Budget will assume [**]...
Strategy. The Distributor and the Supplier will strive to optimize the exchange of information with regard to market developments and the strategic approach of the market.
Strategy. The Area Tourism Plan for the Outer Hebrides was the first one to be completed in Scotland and is commended as a good example of best practice in area tourism planning and partnership working. A number of meetings of the Area Tourism Partnership Group comprising CnES, VisitScotland, HIEIG, and the Outer Hebrides Tourism Industry Association have taken place with the venue for these meetings being rotated throughout the islands. Good progress has been made towards delivery of the Area Tourism Plan to 2009. An advisory paper on use of Gaelic within and by VisitScotland was also produced. TOURIST INFORMATION SERVICES VisitScotland operated five Tourist Information Centres in Castlebay, Lochboisdale, Lochmaddy, Tarbert, and Stornoway during the tourism season employing 14 staff. The TIC’s had over 80,000 visitor customers (an increase of 24%), dealt with over 10,000 telephone enquiries, over 3,000 email enquiries, 500 letter enquiries and also transacted 1,156 accommodation bookings (an increase of 6.5%). VisitScotland also provide information via a number of unmanned Tourist Information Points throughout the islands as well as at inter-island ferry waiting rooms and libraries. VisitScotland undertook a £10,000 refurbishment of Stornoway TIC and Castlebay and Lochboisdale TIC’s are currently having upgrading work done. Brochures were also distributed at CalMac offices at mainland ferry ports to foot passengers and car drivers. A bid has been made for funding to introduce Plasma information screens to all TIC’s.
Strategy. All hours outside the retainer option selected will attract a fee of $150+GST per hour but will be discussed before actioned.
Strategy. Homeland Preparedness Project (HPP) will promote these volunteer opportunities through an integrated strategy of awareness, outreach, and public information.
Strategy. A method, approach, or activity chosen to bring about a desired prevention Outcome.
Strategy. The deployment of the PPB Officers will be accomplished to provide the best direct support of the Clean & Safe Safety Coordinators and other personnel. They will be on a common radio frequency allowing the PPB Officers to use the Safety Coordinators as "eyes and ears". The PPB Officers will also monitor the BOEC police dispatch channel. They will focus on order maintenance, high visibility patrol, and fixing chronic problems (problem solving). The PPB Officers will generally be deployed on bicycles to better facilitate this strategy. Day to day deployment and coordination of the PPB Officers will be the joint responsibility of the Clean & Safe security vendor and a Central Precinct Sergeant as designated by the Central Precinct Commander. To ensure objective #2, the PPB officers will attend the Clean and Safe Security roll call at the start of their shift as well as the Central Precinct afternoon pre-relief roll call at mid-shift. The PPB Officers assigned to the District will be available to Central Precinct Patrol Officers for high priority cover situations but will not normally be available for dispatched calls. Priorities:
Strategy. The Strategy document details the policies, strategies, roles and responsibilities for each component of the NFMS. Key components include: • An integrated harvest planning system that incorporates the environmental , social and environmental and socio-economic considerations that must be addressed. • Skill development, training and codes of practice (refer to attachment 6) for staff and contractors. • Measuring and improving performance through monitoring and audit. • Communication and transparent decision making processes for forest management. • Participation processes for implementing Regional Forest Agreement outcomes. • Information systems using best available knowledge. • Research & development. • Silviculture strategy based on maintaining or increasing the productive capacity of the forest while managing for ecological values. • Review & continuous improvement processes.
Strategy. As the term is used in its application to prevention, it encompasses broad-based approaches or generalized activities to be used in attempts to delay the onset, reduce, or cause the cessation of the use of alcohol among minors and/or the use and abuse of legal and illegal drugs and substances by all members of a given population.
