Mental Process Paper - Free Essay Example

MENTAL PROCESS Mental Process Paper Taumaoe A. Gaoteote OI/361 April 19, 2010 Patricia A. Lott In order for any organization to be successful and stay successful, it will need to have creative leaders and employees. Creative leaders and employees are the ones who introduce positive change and make quantum leaps forward in creating new products and processes. So it is definitely important that an organization create an environment or climate in which it promotes and encourages creative intelligence. This paper will talk about the four styles of creative intelligence and analyze their influence on organizational decision making. The day to day operations of an organization is comprised of so many different moving parts depending on what kind of product or service it provides to the consumers. For the organization to operate smoothly, and keep up with demands as well as future endeavors or projects, it is constantly under analysis and observations to determine what works and what doesn’t work, what is the competition like and how will it counter and remain successful. With all the analysis, based on past performance and productivity, the organization has to plan for the future so that it stays successful or so that it will meet or exceed expectations in upcoming years. This is just one of the scenarios that an organization goes through. The organization makes decisions constantly, but prior to making those decisions, there are a lot of things to consider. This is where creative intelligence is extremely important, because it will have a huge influence on the decision making process. An organization has to tap into the creative intelligence of its personnel because that is where the creativity, innovation as well as other factors that will insure an organizations success. There are four styles of creative intelligence; inspiration, intuition, imagination and innovation. Each of these styles influences the decision making process or any organization. Inspiration Dictionary. com defines inspiration as â€Å"an inspiring or animating action or influence†. It also says that it is, â€Å"something inspired as an idea†. Decisions are at the heart of leader success, and at times there are critical moments when they can be difficult, perplexing, and nerve-racking. When person or organization is inspired by an act or performance, it will influence the organization in making a decision because it is inspired, or through the inspiration of their Founder, Chief Executive Officer, or Manager. In any case, inspiration will influence the decision making process of any organization. Intuition Like it is mentioned in the text, this style focuses on results and relies on past experiences and performances in order to make a beneficial decision for the overall success of an organization. Intuition will have a huge influence on the decision making process of a person or an organization. Surely a person before making a decision on a purchase for example will consider his or her past experiences prior to making that decision. An organization is similar in that regard. An organization will take in to account what happened in their past concerning a process or product and the results of that prior to making any new decisions that may affect the success of the organization. Imagination This style focuses on the imagination or vision of the leader or employees. Having a certain vision of what and where the organization needs to be at a certain time, as well as what it should achieve by that time is important. When there is a vision, the vision becomes the mission or the goal for the organization, whether to be the leader in its service or the leader in the arena with regards to the product that it produces. That will have a huge influence in the decision making process of any organization. Innovation As mentioned in the text, this style â€Å"concentrates on problems and data and is very systematic†. In any organization, it is extremely important to have a leader or employees that systematically look at the entire organizational process, as well as its products to see if there are problems, or potential problems. This way, the organization can take steps to implement solutions to resolve those problems or prevent those problems from reoccurring. It is clear that innovation will truly have a huge impact and influence on an organizations decision making process. In the operation process of an organization, problems are going to occur, and mistakes are going to be made. These problems and mistakes cannot continue or it will stifle the success of an organization. Therefore, an organization will take those into consideration when comes time to make a decision. In Conclusion, creative intelligence is an important key, when it comes to the decision making process or mindset of any organization. More importantly, identifying those assets within an organization and exploiting those assets, by creating an environment where they are sought out for suggestions, recommendations will ensure long term success for any organization.

Exploration of expanded access of investigational products - Free Essay Example

Question 1 Should the public have a right to investigational treatment outside expanded access, defend your choice? Expanded access or the compassionate use refers to the outside usage of a clinical trial of an investigational medical product that is the medical product that has not been approved by the Food and Drug Administration FDA. Food and Drug Administration Expanded Access is legislation that aims at providing seriously ill patients who have exhausted the available treatments options and thus have no other comparable standard treatment option to gain access to biological agents and investigational drugs. FDA was enacted by the United States Congress to prohibit the sale of misbranded, mislabeled, or adulterated foods and drugs in interstate commerce. According to the author’s opinion, the public should have a right to investigational treatment outside expanded access. Some patients are not eligible for clinical trials and thus outside expanded access can lead to major inventions of medical products. Ordinarily, investigational drugs may be used under controlled trial. Investigational medical products to be used by a patient as part of the clinical trial is preferable since the trial can generate crucial data that may lead to the approval of medical products; a good example is the case of Josh Hardy (Kroll, 2015). Patients with no ongoing clinical trials or are not eligible for any clinical trials can receive the medical product through expanded access when appropriate. As much as the public have the right to investigational drugs, they should strive to balance between the need and patient safety. The right to investigational treatment outside expanded access can lead to the invention of medical products useful for healing rare diseases with no treatment options as the same time can be dangerous to the patients’ health (Mahady, 2015). That is why the balance between patient safety and need should be emphasized. There has been a lot of conflict between FDA and the Abigail Alliance about when is a drug safe for use. Abigail Alliance blames FDA by saying that it should make drugs accessible on the first stage of development. Each person, if she or he shows the willingness   to undertake investigational treatment outside expanded access should be allowed to do so under close check by a highly qualified physician (â€Å"Food and Drug Administration,† 2016). Question 2 What are the implications of expanded access on drug development from the pharma and FDA perspective? Abigail Alliance claims that FDA makes drugs available for terminally ill patients at early stages of testing. The FDA perception on implications of expanded access on drug development is that it can lead to more useful data that may lead approval of the medical products and their improvement. FDA has facilitated access to investigational drugs to treat patients with serious and immediately life-threatening diseases or conditions with no therapeutic alternatives. Expanded access programs are majorly restricted to patients ailing from serious or life-threatening diseases and have exhausted all standard treatment options and are not eligible to enroll in clinical trials since they don’t meet the inclusion criteria. Pharma companies supply investigational drugs at no cost. This is likely to result in financial issues that are likely to face pharmaceutical companies. Pharma has the perception that supply of unapproved drugs can lead to legal acts being taken against them. The pharma and the FDA have in mind that the drug administered for trial and research purposes can benefit some patients, others experience no effect, and some patients can be harmed by the drug. The pharma and the physicians are faced with difficulties when prescribing drugs that are to be used for the first time. Therefore, from fear of overdose they may prescribe less dosage which has no impact on the ailing patients when the same medicine if properly prescribed could offer significant healing (Ross, 2009). Some patients can refuse to take drugs which have not yet been approved as safe for use. Expanded access gives crucial data that help weigh the benefits and risks of the medical product. Question 3 Are the FDA regulations and guidance in place for expanded access sufficient in both protecting the public’s safety and also addressing the ethical concern of allowing patients with severe or life-threatening diseases the option to have access to an investigational product where the benefits and risks are still being explored? FDA has outlined set of regulations and guidance that govern on how medical products under investigation are being administered to patients with severe, life-threatening conditions. FDA has these regulations in place to ensure a balance between benefits and risk that can be associated with investigational drugs (â€Å"Food and Drug Administration,† 2016). According to the opinion of the author, the FDA regulations and guidance set in place for expanded access are sufficient in protecting the public safety and addressing the ethical concerns of patients suffering from severe, life-threatening diseases. For example, the Abigail Alliance once send a proposal to the FDA   suggesting that drugs should be made available to the patients with severe, life-threatening illness for purchase after the earliest testing stage. The FDA declined the proposal, one of the FDA regulations and guidance require three to four stages of medical product testing before it can be sold to the public ( Jacobson Parmet, 2007). The act of rejecting the proposal from Abigail Alliance shows that FDA is committed to ensuring the safety of the public. It is more dangerous to make medical products under testing and research available to the public in its initial stages; this poses more risks as compared to the benefits. Making a drug available to the public at its first stage of development poses a great risk to the public safety. The drug can have great negative impacts than positive impacts and thus harm a large group of people since it is not under controlled testing. FDA rejecting Abigail Alliance proposal proves that its regulations and guidance is sufficient to protect the public and patients with severe life threatening illness.