Medical Affairs Organization- MAPS

  It is common for pharmaceutical companies to consider evidence generation as the responsibility of individual departments (e.g., clinical development, medical affairs and health economics and outcomes research). This typically means that evidence is generated in a sequential fashion; for example, waiting for regulatory approval before initiating an outcomes-based study. This is a relatively risk-averse strategy that has served the industry well in generating evidence to satisfy regulatory and reimbursement decisions, and until recently, there has been little need to improve it. End point strategy Clinical research should ultimately improve patient care. For this to be possible, trials must evaluate outcomes that reflect real-world scenarios and address the concerns of patients, physicians and payers. Pharmaceutical companies should adopt approaches to identify end points that translate into valued outcomes that can be measured in the real world. One way is to ensure that trials a...

  At a glance Healthcare compliance is the practice of adhering to federal healthcare laws and regulations. Compliance laws are intended to help protect patients, safeguard sensitive information and help mitigate and prevent fraud, abuse and waste in the healthcare industry. Noncompliance poses serious risks to patients and can result in legal action. Global healthcare is a trillion-dollar industry that focuses on the safety and care of patients. In the U.S., compliance in healthcare is of the utmost importance due to the sheer size of the industry, the risks associated with it and its dynamic nature. These factors open up the possibility of fraud and abuse, and this is where healthcare compliance comes in. Healthcare compliance is the practice of adhering to federal healthcare laws and regulations, which prohibit and prevent fraud, abuse and waste in the healthcare industry. It’s founded on ethical standards for patient treatment. Learn what healthcare compliance is, what the laws...