Regulatory Affairs Quotes & Sayings

Sociologists of regulation - such people exist - talk about something called 'regulatory capture'. This is the process whereby a state regulator ends up promoting the interests of the industry it is supposed to monitor, at the expense of the public interest. It can happen for a number of reasons, and many of them are very human. For example, if you work in the technical business o f drug approval and pharmacovigilance, who can you chat to about your day's work? To your partner, it's all baffling and pedantic; but to the people in the regulatory affairs division of the companies you work with every day, they understand. You have so much in common with them. So industry bodies - not even necessarily the pharmaceutical companies themselves - might offer things as intangible as friendship, and opportunities to socialize. — Ben Goldacre

A US firm with a large "government affairs" division dedicated to lobbying politicians in Washington, a Russian company founded by an oligarch with personal friendships in the Kremlin, and an Indian company finding its way through the tangle of decades-old licensing and bureaucratic requirements face drastically different regulatory environments from one another, let alone from a start-up seeking to enter an industry for the first time. — Moises Naim

As a medical doctor who chose a career in artificial heart technology rather than clinical practice, I decided not to take an internship, which is required for licensing. Instead, I work with invention, manufacturing, regulatory affairs, and clinical application of artificial hearts. — Robert Jarvik