Kamilah Rashid
Mercer University College of Pharmacy, USA
Title: Regulatory affairs mobile application: Barriers, benefits and implications for patients
Biography
Biography: Kamilah Rashid
Abstract
Eighty-seven percent of adults use the internet and 90 percent have cell phones, with 78 percent using smartphones. Over the years, the rising trend of people with access to the internet and those who are smartphone users aided in the exponential development of mobile applications. In this digital age, there is a constant demand for convenient access to databases, particularly those that are health, drug or regulatory-related, in part due to healthcare concerns in the US. Currently, there exist a vast number of mobile applications that fall within these categories. The majority of health related applications on the Android and Apple markets focus on the diagnosis of diseases and other conditions, cures for diseases, treatment or prevention of diseases, causing them to be defined as mobile medical devices according to the FDA standards. Additionally, the FDA supports the rapid provision of regulatory information to patients. In today’s competitive and highly regulated healthcare environment, it is essential to develop creative and innovative health related applications to address regulatory issues. Currently, there are no US mobile applications that provide a comprehensive review in addition to continuous updates on all facets of regulatory affairs. The development of a regulatory affairs mobile application that offers healthcare professionals and patients with critical information regarding regulation of clinical trials, safety issues, marketing approval applications, post-marketing activities and more, would help bridge the knowledge gap between patients, healthcare providers, and pharmaceutical companies.