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 agenda

  1. classroom_web.jpg
    28 September '20

    Introduction to Regulatory Affairs 2020

    Brussels

    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.

    The program proposes an introduction to the legal, scientific, organisational and administrative aspects of medical products given by experienced tutors from university, FAMHP and industry.

  2. classroom_web.jpg
    29 September '20

    Session Pharmacovigilance

    Affligem

    More information will follow soon.

  3. Clinical.jpg
    22 October '20

    CTR Session

    Brussel

    More information soon

    Save the date!

  4. Annual conference.jpg
    17 November '20

    Healixia annual conference

    Brussel

    More information soon

    Save the date!

  5. classroom_web.jpg
    03 December '20

    Session Medical Devices

    Affligem

    More information will follow soon.