So, what has changed? In short, business. Historically, most regulatory professionals started their professional lives in the R&D laboratories, until beginning their 'retirement' in Regulatory. These days, there are many more healthcare professionals in Regulatory who have intentionally chosen the field as a career, and frequently switch between industry and the regulatory authorities. The best advice companies can obtain is from a combination of ex-regulators combined with that of industry development experts with a business focus. The attitude now is not "We can't do that," but rather "How can we get it done? Within given time and money constraints, how do we get the product onto the market? What is the best route? Which market or markets first?" The best regulatory people work hand-in-hand with marketing and R&D to develop innovative, risk-taking development plans that take advantage of new technological and regulatory developments to accelerate time to market. With new products expected to have significant revenues from Day One, small decreases in time to market equate to material gains in revenue and profit. Employing adaptive clinical trial strategies, obtaining early buy-in from the major regulatory authorities, and avoiding pitfalls in processes can accelerate development and help to prevent costly errors. In the days before email, the regulatory function was usually combined with a quality assurance (QA) or compliance role (and this is still frequently the case in the medical device industry). This fitted in very well with the perceived role of Regulatory as the 'company police,' ensuring compliance with all relevant legislation, regulations and guidelines. Today, these two roles are separated. Regulatory affairs should be the driver of development, accelerating rather than putting a brake on projects. Compliance and QA are, of course, critical functions, but should be entirely separate.
Source: Strategic RA Consulting
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