Regulatory Affairs

In almost all countries of the world, governments evaluate the safety, quality & efficacy aspects of products which may present a risk to their citizens. Regulations relating to standards and products are multiple, varied and developing. Pharmaceutical and other directives are so complex that it was necessary to develop a new scientific discipline that has become known as "Regulatory Affairs".

The Regulatory Affairs Professionals

A Regulatory Affairs Professional works in the field of human and/or animal health pharmaceuticals, medical devices, cosmetics, hygiene and/or agrochemical products or foodstuffs. He/she monitors the regulations, advises on the legal and scientific constraints and requirements, collects, evaluates and presents Regulatory Affairs documentation to the government agencies and finally negotiates licenses with the authorities. The skill in analysing and presenting both written and oral evidence before a panel of experts such as those scientists, pharmacists, doctors and lawyers who run the government agencies or who make up the Evaluation Board, requires considerable understanding of both legal and scientific matters.

The very nature of Regulatory Affairs brings regulatory personnel into contact with almost every discipline within the pharmaceutical and related industries. This may include pharmacologists, toxicologists, analytical chemists, pharmacists, medical doctors, veterinarians, engineers, physical chemists and statisticians. However the work is by no means limited to science but extends to legal, manufacturing, intellectual property, marketing, advertising and economic areas, so the scope is extended to the sales and marketing organisation. An ability to liaise closely with every kind of specialist is a crucial part of the job.

The Regulatory Affairs domain originates from BRAS (Belgian Regulatory Affairs Society). This organization provided training and networking within the world of Regulatory Affairs for 30 years. We can rely on our Healixia Regulatory Affairs Education Group for the elaboration of our trainings/events/sessions on the topics with a link to Regulatory Affairs. Here are the members of the Education Group: