Regulations 4.0: Digitally Transforming the Regulatory Space

Abstract

Regulators, Patients and Industry share the space and work together, with this they share their ‘real-time’ data. Which helps in faster analysis, investigation and generate greater insights and helps in better prediction. Regulators and industry will be able to identify the risks faster and then act on it. If we follow a data driven approach the relations with regulatory becomes advantageous. With the help of advance analytics, we detect new data patterns and trends which help in effective approach and help further in compliance mapping and change assessment. The ultimate goal is for industry is to lead and ‘self-regulate’ and improve transparency. In this paper, we discuss a new paradigm, where in life-sciences companies and regulators work together in a collaborative way to build stable rules and regulations instead of applying restrictive and punitive approach to regulations.