This would not only result in less reliance on one person and a more rapid update of the information but would allow everyone to contribute.
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In the last section, the TRACE example will be used as the base for discussion and perspectives regarding the communication systems in such European research projects. For the communication between the partners, in addition to the conventional methods of communication e.
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In the framework of the TRACE project, the scientific committee decided to centralise the communication inside the consortium around the Intranet to facilitate the exchange of information between participants, to encourage them to collaborate and to manage the project in real time Vermeulen et al. The successful experience of some partners with MS SharePoint directed the choice to this software. To ensure the confidentiality of the information and data, a website secure server certificate SSL was installed and personal logins and passwords delivered to each TRACE partner giving him access rights depending on his management level in the project.
To facilitate the communication between the actors of the project, different tools and functions are available such as TRACE mailing lists, alert system and discussion boards. It is managed by the webmaster in close collaboration with the coordination team and the scientific committee. It was agreed at an early stage in planning of the project that the Intranet would be the only major internal communication route for the consortium.
This strategy was enforced despite initial resistance preference for e-mails by reluctant users of the new system. They crucially inform all the partners about the project management and announce the meetings scheduled in the frame of the project.
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To be sure that all the partners are well informed, an automatic alert e-mail notifies each of them when an announcement is made or an event entered. Each event can be linked to a workspace dedicated to give information about the attendees, the agenda, the presentations, the report and any document concerning the event. Each workspace is managed by the meeting organiser and access is restricted to members of the relevant group. A short description displayed at the top of the library mentions to the user the content and the access rights.
In the general documents section, each document can be classified regarding the work package WP1 to WP14 , the deliverable, the type of document EC document, template, reports, etc. Other sections include documents regarding contribution to standards, dissemination activities, financial or intellectual property aspects. This library can be accessed by all members of the consortium. Different views have been defined to retrieve easily a list of people with the same role in the project Scientific Committee, Group1, WP13, trainees, etc. This information is also used for the public website.
All the information dedicated to the public website has to be validated by members of the scientific committee or by the web-correspondents before it is included in the relevant databases and to be disseminated on the Internet.
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This provides secure internal partitioning of workspace and allows the partner to share drafts within his work group. Such security is valuable in addressing IP concerns and ensuring that the workspace is used. Each work package leader is free to organise the documents as he wants, through a library to upload the documents or through a sub-Intranet he can manage himself.
One of those work areas is dedicated to the management of the collection of data about the samples collected during the project. Each data provider can edit the file on line and update it. To manage the samples and files, a coding system was defined in order to have an unique code through the project and avoid any confusion. The building of one file for each person responsible for sampling allows the management and data validation. For each file, one sampling or site responsible person has the responsibility to check the data relevance and to validate them.
The data manager can follow the data collection through the version history and through metadata regarding each file modification date and status. Once the data are validated, they are imported in the central samples database. Each work package leader has the responsibility to update the status of their deliverables. The different views give quickly an overview of the tasks, the tasks due today, the active tasks or the tasks assigned to other partners.
To help the coordination team in the management of the project, it was decided to use a project management software.
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This software was selected since some WP leaders had experience with the local standard release and for the compatibility with other MS products. The advantage of the web access release is to allow to each WP leader to manage the tasks of their work package and to each participant to follow up their work through the web. Nevertheless, the researchers seem not yet ready to use such software, which is quite new in the research world and requires some skills.
A procedure has been defined through the Intranet site for the submission of a publication by a scientific committee member and the approval of a publication by the project management board. Initially the webmaster received ten enquiries a week; this has reduced to four a month after two years of the five year work programme.
It also includes a discussion board open to each partner to debate about any question regarding the project. Even so, analysis of the data reveals that the managers of the project have a much higher usage than participants, suggesting that the primary function of the system is management and, to some degree, one way communication. It also serves to promote some activities required by the EC including the gender issues or the ethical, legal and societal issues. To ensure the security of the system, the website is installed on a dedicated server and protected by a firewall and an antivirus software.
To avoid the display, and potential spam abuse of personal e-mail addresses on the website, generic TRACE e-mails have been created. To develop a project face, both to the participants and the public, a logo and layout were produced using a professional designer. The logo represents the traceability symbolised by a green ball travelling through a blue line from right to left through the project name: TRACE.
Several releases colour, black and white, full or reduced have been created in order to be used in all the templates and documents produced during the project. The website layout was designed to be as simple as the logo, without too much embellishment in order to drive the visitor directly to the main topics and to facilitate the quick downloading of the web pages. It includes five pictures showing the commodities to be used in the demonstration activities: mineral water, cereal, honey, meat and chicken.
The main home page is divided in three frames: the main frame displaying events and news including those for the TRACE project, the left frame with general topics on traceability and authenticity and finally the top frame with links to the project homepage and to contact and sitemap web pages. The events and the news displayed in the main frame can be provided by all the partners through the Intranet with approval by the web-correspondents and notified to the webmaster before it is published, as explained in the previous section.
On another hand, by using login and password, the web-correspondents, representative of each workgroup and country, can put directly information on line by accessing to the news and events administration tool. Additionally, as more competitors introduce anatomically-shaped products that compete with ours, we may face additional pricing pressure that will impact our future results.
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The long-term safety of our products has not fully been established and our breast implants are currently under study in our PMA and post-approval studies, which could reveal unanticipated complications. We currently market our silicone gel breast implants in the United States. These products have received pre-market approval from the FDA.
Additionally, we compare our five-year data to our competitors' six-year data in some cases in this prospectus, and our longer term data may change due to an increase in such complications or consequences over time. Further, future studies or clinical experience may indicate that treatment with our products is not differentiated to treatment with competitive products.
Such results could slow the adoption of our products and significantly reduce our sales, which could prevent us from achieving our forecasted sales targets or achieving or sustaining profitability.
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Moreover, if long-term results and experience indicate that our products cause unexpected or serious complications, we could be subject to mandatory product recalls, suspension or withdrawal of FDA clearance or approval and significant legal liability. Any negative publicity concerning our products could harm our business and reputation and negatively impact our financial results. The responses of potential patients, physicians, the news media, legislative and regulatory bodies and others to information about complications or alleged complications of our products could result in negative publicity and could materially reduce market acceptance of our products.
These responses or any investigations and potential resulting negative publicity may have a material adverse effect on our business and reputation and negatively impact our financial condition, results of operations or the market price of our common stock. In addition, significant negative publicity could result in an increased number of product liability claims against us. If we are unable to train Plastic Surgeons on the safe and appropriate use of our products, we may be unable to achieve our expected growth. An important part of our sales process includes the ability to educate Plastic Surgeons about the availability of anatomically-shaped breast implants and train Plastic Surgeons on the safe and appropriate use of our products.
If we become unable to attract potential new Plastic Surgeon customers to our education and training programs, we may be unable to achieve our expected growth. There is a learning process involved for Plastic Surgeons to become proficient in the use of our anatomically-shaped products. It is critical to the success of our commercialization efforts to train a sufficient number of Plastic Surgeons and provide them with adequate instruction in the appropriate use of our products via preceptorships and additional demonstration surgeries.
This training process. Following completion of training, we rely on the trained Plastic Surgeons to advocate the benefits of our products in the marketplace. Convincing Plastic Surgeons to dedicate the time and energy necessary for adequate training is challenging, and we cannot assure you that we will be successful in these efforts.
If Plastic Surgeons are not properly trained, they may misuse or ineffectively use our products. This may also result in, among other things, unsatisfactory patient outcomes, patient injury, negative publicity or lawsuits against us, any of which could have an adverse effect on our business and reputation. We are required to maintain high levels of inventory, which could consume a significant amount of our resources and reduce our cash flows.