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What is the pharmaceutical regulatory activity

Great masters teach that the more you know a subject, the more easily you will be able to explain it. Those who have the art and secrets of something are also able to make it very easy for laymen’s eyes and ears.

I have been living and working in this sector for 40 years now, the so called regulatory affairs. I say ‘living’, along with ‘working’, as I am so integrated and permeated in the shades of this fascinating job, that one can say that I breathe it, I possess it and I cultivate it as if it were, in fact, something alive.

And, as difficult as it is to believe it, the rules – any rule – are actually something alive, interpretable, usable and open. It is but rarely just a matter of written rules, as behind each of them there is a rich history of practice, uses, social and economic trends and developments, and above all, much ‘future’. Rules always trace the path for the future, never for the past.

The regulatory sector has been a special protagonist of an incredible regulating acceleration in the last 20 years, also – and particularly – due to the enlargement of markets and national and legal borders.

I remember when this work had not the dignity of either a name or an international definition. One talked of proxy, i.e. a person going to the Ministry of Health to ‘handle’ the procedures submitted by a company. Not an activity then, but rather a person.

Usually, most companies had their trusted person, entrusted with this task. The proxy had no need to know the regulations well – quite limited at the time – he/she only needed to be familiar with the Ministry practice and procedures to obtain the applied authorisations as quick as possible.

Several factors contributed to overturn this practice. Mostly the introduction of the faxing machine, then of the computer, and finally the development of many European regulations.

The ‘death’ of the proxy was a painless agony, that slowly erased the usefulness of this figure, with no special fast revolution: documents that were delivered by hand were then sent by fax, and today by certified e-mail. But the true revolution of the sector is the regulation complexity: now we need to know what we are talking about, and we need to know it well, because the submission of a procedure to the Ministry or to the Agency is just the last piece of the preparation puzzle.

Usually a particular activity does not develop through a specific planning: they are born out of the moment’s needs and the future developments of the market. Without knowing, some people are able to provide the required answers, earlier and better than others, thus contributing to slowly change the working structural setting.

The change in the surrounding environment – and therefore in one’s working environment as well – can be faced by osmosis, following the flow of the events, so that people and their way of working change imperceptibly, as needed. However, someone paying attention and being aware of the secrets of his/her job can also anticipate this change and be ready, with the right solutions at the right time.

Everything around us tells us something. You just need to listen and decode. It is not easy and most of the times it is not rational: it is just an instinct. It happens for a sort of unconscious influence, that is however very clear in its goal.

The regulatory affairs as it is structured nowadays is no more the competence of an individual: it requires the presence of more stakeholders, possibly with different technical, scientific and clerical culture, and with a good knowledge of foreign languages, because it is necessary to know the European and national regulations, as well as those of the extra-EU countries.

The borders of our work have opened, and it is not for everyone to keep pace with such novelty. One needs flexibility, preparation, continuous updating and much curiosity.

Experts for specific sectors are not born out of chance, if there is no demand. A dynamic relation is established between the business partners – the expert and the demanding part. This is what happened in the world of regulatory affairs, where more and more complex rules and practices contributed to a revolution in the demand. In few years the simple proxy gave way to the regulatory expert. The regulatory consultancy practice has soon followed, with a capacity to face more chorally any business strategy. So we moved from a little gratifying job – moving around the Ministry corridors – to sit at the table of those who shall decide the company’s future.

It is a dialogue fed by shared goals and actual competence: we noted that the cooperation and discussions between our regulatory experts and our clients can go as far as their respective culture and knowledge can get.

Recently, something even more new is happening, not everyone doing our same job has realised that.

We are ready to take on new challenges: our organisation is made of 90 people with different academic qualifications. We cooperate with hundreds of companies all over the world, with a unique and wide global vision, involving the sector of medicines, medical devices, food supplements, cosmetics and biocides. And the good thing is that we are never tired of changing.

Sante Di Renzo