IS IT TIME FOR ACADEMIC PREPARATION OF FUTURE REGULATORY AFFAIRS PROFESSIONAL ?

The regulation of medical products has been expanding since early
in the 20th century. Regulatory agencies are being established in
an ever-increasing number of countries across the globe. Those
that have established regulatory agencies are revamping their
systems and attempting to harmonise with other selected
jurisdictions. Agencies are also requiring more compliance activities
and increasingly complex activities from the regulated industries
that market products within their jurisdictions. This mushrooming
regulatory framework and the associated increased regulatory burden
have placed significant strains on the existing pool of experienced
regulatory affairs professionals worldwide. In fact, there are those
in the industry that have expressed this current shortage of
regulatory affairs professionals as ‘massive’1. This conclusion is further
supported by a 1999 study2 that suggested that the demand would
continue to increase. All one needs do to personally validate these
beliefs is to talk to the many employers who are struggling to find
experienced regulatory affairs professionals and also to the regulatory
affairs professionals who are barraged with regular telephone
enquiries from placement agencies with numerous and lucrative new
positions. As the regulatory affairs profession is practised in a variety
of environments, it is logical to assume that this shortage of qualified
personnel is shared not only by the regulated industry but also by
regulatory agencies across the globe.

SOUCE: Medical Device Consultants Inc.