The false myths of Regulatory Intelligence
Regulatory Intelligence: the world of regulatory affairs has been talking of nothing else. And if, on one hand, this is certainly a key tool available to the professionals of this sector, on the other hand there is much misinformation on this regard.
Regulatory Intelligence is none other than a set of information, especially of regulatory nature, that can support the development of drugs, but also of guidelines or health policies, and whose knowledge allows companies to shape their strategies, avoiding any waste of time and resources, thus aiming at the goal directly.
An example of the application of the Regulatory Intelligence is collecting information on local regulations for marketing authorisation procedures of medicines and other products, whose critical examination allows full support to business decisions.
Many believe, for instance, that this requires extraordinary expertise and several university degrees. Actually, whoever deals with regulatory affairs has been continuously practising Regulatory Intelligence. When one wishes to obtain effective results, however, one should be capable of collecting full information, examining them in depth and determining the more effective strategy to solve the current issue.
Moreover, it is erroneously believed that Regulatory Intelligence is for big companies only. It is true, on one hand, that big companies can count on a large staff capable of analysing the regulatory landscape in details, but it is also true that today many tools for management, analysis and strategy are available to small companies. Such tools reduce the time for research, so that time and energy can be devoted to analyses and detailed study.
Another myth to dispel regards the presumed costs of Regulatory Intelligence. Actually, this is always a useful investment, in terms of both time and money, as it reduces the workload improving quality. It is not true that one must have in place a Unit specifically dedicated to Regulatory Intelligence, although this can be of great help.
Finally, many are scared by the complexity required to produce high-quality information leading to effective results. Indeed, Regulatory Intelligence requires continuous refreshers and steady innovation, and cannot be obtained with tools and working ways belonging in the past. One should be able to see the whole picture, identifying its essential elements, examining them, and linking them one with the other to catch the trend and keep pace.
No doubts, all this requires a long experience in the field, familiarity with the evolving procedures, sufficient (but not huge) resources to be able to count on progressive tools, ability to penetrate the surface to see hidden patterns, continuous but not pressing efforts in all working phases.
And where an individual small company cannot reach out, the use of specialists of this sector – such as regulatory consultants to outsource part of the company activities – can contribute to the achievement of Regulatory Intelligence goals.
Written by: Sante Di Renzo
Foto di Gerd Altmann da Pixabay
