Regulatory compliance

Health Canada has issued its first guidelines for SEBs harmonized with the strict regulatory process used by the EMA in March 2010 but this guideline is under refinement and revision. For SEB approval a sponsor must mention the name of the reference biologic drug which already authorized and marketed in Canada. The same reference biologic…

Following the disastrous impact of a number of corporate and accounting scandals, especially those involving major corporations such as Worldcom and Enron, U.S Congress decided to pass the Sarbanes-Oxley Act of 2002 (SOX). This had come not long after investors and companies lost billions of dollars due to the result of such corruption, thus having a negative impact on financial markets and investor trust. The enactment of SOX set forth new standards and provisions which sought to improve the…

Public Compliance: A Neutralizing Attempt To establish relevance between the scope of modern prejudice and its connection to public compliance, one needs to understand the impact of conformity. As both a direct and indirect implication of social identity, conformity facilitates the sense of belonging elaborated earlier. Respectively, the basic definition of conformity specifies changes in an individual’s behaviour resulting from the real or imagined influence of others (Aronson et al., 2013, p.…

Theranos, the blood-testing startup once beloved by investors. has recently been under fire. Regulatory boards have frowned upon their lab's lack of compliance with CLIA laboratory testing standards, and as a result, the CEO of Theranos has been banned from operating labs in the United States. This resulted from a lack of efficient sharing of information, and it poses a ripe problem for the future leadership of the company to solve. What is the best way to solve this problem? Should the…

Producing the product is only a small part of the battle to having a successful company; the main challenge is getting the product in-front of customers. Since Ronnie’s Refreshments will be catering to customers seeking a healthier beverage alternative, getting our product in-front of the right people is our primary goal. Since we have already determined our target market, it is equally important to determine the distribution process of our products. Determining how we will get our juices…

Clinical risk factors like falls, infections, pressure ulcers, and dehydration can be common occurrences but are preventable. There is risk to staff and employees, especially with Alz's or dementia patients. Bites, bruises, infections and back strain can all be risk factors for employees of skilled nursing facilities. (Willis North America, 2012) More uncommon risk factors such as wrongful death lawsuits, neglect, or federal investigations are major risks factors that are avoidable with the…

Money laundering can be a complex process that involves three different stages, the first being Placement, which in loves physically placing illegally obtained money into the financial system or retail economy. Money is most exposed to detection and seizure during the placement stage. Another stage of money laundering consist of Layering which involves separating the illegally obtained money from criminal source by providing a series of transactions trail to make it difficult to trace money to…

agencies. Rather removing the program would result in model contracts and binding corporate rules with individual companies which are quite inflexible and difficult to implement on large scale. With these reforms and proper check by regulators and compliance bodies, the Safe Harbor will definitely become more effective in safeguarding citizens commercial privacy…

In this Unit 9 Assignment, I will be preparing a policy brief on offshore energy planning and management. This brief will discuss three options such as the complexity of overlapping statutes through regulatory agencies, oil spill prevention and response, and the efforts to reduce environmental impacts through research and conclusions about the predicted effects of these policy options. A final recommendation of which policy option would be best utilized to ensure success. According to the…

their code of conduct because it lists the expectations and rules that an organization wants that person to abide by. As the CEO of chipotle the key areas which I find holds a significant importance to the business are the Integrity Statement , Compliance with the codes , Anti-Discrimination, Harassment and Sexual Harassment Policy, Protection of the Company’s Confidential Information, and Employee Recourse. The Integrity…