Regulatory Affairs

Logo domeinen_BRAS2.jpgIn 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.

Regulatory Affairs Professionals and other professions

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.

Regulatory Affairs Domain within Healixia

Within Healixia we have the Regulatory Affairs domain. This domain originates from BRAS (Belgian Regulatory Affairs Society). This organization provided training and networking within the world of Regulatory Affairs for 30 years. 

Healixia Regulatory Affairs Education Group.jpg

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. You can find the members here:

  • Annabelle Bruyndonckx - Simmons & Simmons (President)
  • Caroline Steensels - In2Pharma
  • Joelle Ameye - TEVA
  • Indiana Tanret - Boehringer-Ingelheim
  • Marian Coquel - Infarama
  • Ingrid Theeuwes - Phara
  • Elke Debie - Janssen Pharmaceutica
  • Pieter Vancaeneghem - Gilead
  • Ann Devrieze - AD Pharma Consult
  • Rembert Van de Sande - Viatris
  • Ann Osselaere - Eurogenerics

Regulatory affairs agenda

  1. beatriz-perez-moya-XN4T2PVUUgk-unsplash.jpg
    18 October '22

    Webinar: The sources of life sciences regulations - part II: Medicinal products


    This session is the second part of a two-part training course on the “Sources of life sciences regulation”. It serves to provide participants with a high-level overview of the rules and regulations applicable to medicinal products for human use in the European Union. The session will include a specific part on the Belgian legislation. It will also provide the audience with practical tips on researching applicable laws.

  2. debby-hudson-IjQdCrknYXI-unsplash.jpg
    17 November '22

    Introduction to Regulatory Affairs 2022


    The course is addressed to people new to regulatory affairs who want to acquire a comprehensive foundation; to regulatory professionals wishing to update their knowledge, and to all collaborators working in close relationship with regulatory affairs and wishing to understand the role of the department.

  3. marvin-meyer-SYTO3xs06fU-unsplash.jpg
    22 November '22

    Healixia workshop on RIP role and RIP legislation


    During this workshop, we will work in small groups, where you can discuss different cases, challenges, bumps in the road, best practices,... with peers. Each group will have a lead who is experienced in the RIP role and RIP legislation.