BRAS is a professional organisation of people involved in regulatory affairs that supports its members to achieve the highest standards through information and training, and participates on an active and constructive way to the policymaking within the pharmaceutical and related sectors.
- Aims of the Association
- How does BRAS opearate?
- Members & Membership
- Education & Training
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.
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.
The Belgian Regulatory Affairs Society was founded in January 1989, for the Regulatory Affairs Professionals in the pharmaceutical and related fields
- to establish the professional identity of its members both within the industry and with the Authorities,
- to set standards for the profession,
- to seek for and to communicate relevant information to its members,
- to provide training in order to promote the highest professional standards,
- to defend the interests of its members at national & European level,
- to create a "partnership" with other Regulatory affairs and allied societies.
The statutes were registered in Belgium, under the law regulating the not-for-profit societies (asbl/vzw).
(Belgian Official Journal identification nr 7269/89 - June 15, 1989).
BRAS is a not for profit association under Belgian law. BRAS is managed by a Management Board structured as follows :
- Presidency, Marian Coquel
- Vice-Presidency, Ingrid Theeuwes
- Treasury, Kuo-Wei Chan
- General Secretariat, Bart Van den Daele
- Education, Annabelle Bruyndonckx
- Public relations, Ingrid Theeuwes
The Management Board is elected by the members for a 4 year term.
A General Meeting is organised annually to which all BRAS members are convened. During this meeting, the Management Board presents the various BRAS activities organised during the previous year and seeks for approval of the financial results, the budget and the membership fee for the next year.
Effective BRAS Members are called Working Members. They directly contribute to the achievement of the aims of the Association by their competence or activities (refer to Aims of the Association under item nr 2).
To become a Working Member one needs :
- to complete an Application for Membership,
- to adhere to the Statutes of the Association,
- to have the application form approved by the Management Board.
- To pay the Membership fee
Each Working Member has a right to vote at the General Assembly.
The Working Member is free to resign from BRAS at any moment by addressing a personal letter to the Management Board.
The General Assembly is entitled, by secret vote requiring a majority of two third of the present or represented members, to exclude a Working Member from BRAS in case of serious events that could jeopardize the reputation of the Association.
Working Members join the Association in their individual rights, not as representatives of their employers, although the importance of receiving the support from their companies is acknowledged. As a consequence, the membership is not transferable to another person.
BRAS presently consist of over 375 Members.
The Honorary Members
Can be admitted as Honorary Member of the Association, any natural person or body corporate person bringing a moral or financial support to BRAS.
This person is not considered a Working Member and as a consequence does not have a voting right at the General Assembly.
The annual membership fee is established on a yearly basis by the General Assembly taking effect for the year thereafter.
The actual membership fee is established at 225 €
The membership fee is due annually and is payable to the BRAS bank account nr (IBAN) BE 18 3100 7494 0165, BIC: BBRUBEBB.
The objective of the education group is to organise symposia, courses, or seminars for the members:
- to gain knowledge of the registration dossier in all its aspects,
- to achieve an in-depth knowledge of the national and European legislation,
- to provide up to date information on developments,
- to improve knowledge and skills in the various areas of interest.
The lecturers are selected on the basis of their experience and/or expertise.
- President, Annabelle Bruyndonckx
- Vice-President, Marian Coquel
- Members of the group:
- Elke Debie
- Agnes Degroote
- Hugues Haesebroeck
- Noëlla Heyman
- Elhem Sbaa
- Carla Sterk
- Ingrid Theeuwes
- Rembert Van de Sande
- Josi Verschaeren
Market Access Group:
- President, Bart Van den Daele
- Members of the group:
- Anne Bruneel
- Katrien Coppens
- Agnes Degroote
- Katrien De Groote
- Lies Delmulle
- Melissa Penninck
- Sven Tops
- Katleen Vandeweyer
- Katrien Van Geyt