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.

Healixia Regulatory Affairs Education Group.jpg

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:

Marian Coquel

Marian Coquel

Managing Director Regulatory Affairs & Quality at Infarama bv

Annabelle Bruyndonckx

Annabelle Bruyndonckx

Partner Healthcare Life Sciences at Simmons & Simmons LLP

Ingrid Theeuwes

Ingrid Theeuwes

PhaRA BV

Joelle Ameye

Joelle Ameye

Teva Pharma Belgium

Ann Osselaere

Ann Osselaere

EG NV

Elke Debie

Elke Debie

Janssen Pharmaceutica NV

Katrien Coppens

Katrien Coppens

KS Pharma Services

Martine Kooken

Martine Kooken

Martine Kooken

Rembert Van de Sande

Rembert Van de Sande

Pfizer N.V. – S.A.

Wim Neckebroeck

Wim Neckebroeck

AxTalis BV

Regulatory affairs agenda

  1. sharon-mccutcheon-eMP4sYPJ9x0-unsplash.jpg
    30 May '24

    Advanced Course CTD module 3 - Quality section 2024

    Brussel

    2-day face-to-face course.

  2. marvin-meyer-SYTO3xs06fU-unsplash.jpg
    06 June '24

    Healixia workshop: Mdeon Deep Dive & Dialogue

    Grimbergen

    During this Healixia workshop, different questions and ethical healthcare practices related to an offered hospitality (by pharma industry) to HCP’s for their participation to scientific events where they have the opportunity to keep abreast of trends in their profession, will be handled. Participants will be able to discuss cases in small groups and have a direct dialogue with Mdeon representatives.

  3. lecture ACRP.jpg
    07 November '24

    Healixia online conference: Pharmacovigilance

    With speaker(s) of the FAMHP.

  4. debby-hudson-IjQdCrknYXI-unsplash.jpg
    25 November '24

    Introduction to Regulatory Affairs 2024

    Brussel

    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.