3 ECTS credits
90 u studietijd

Aanbieding 1 met studiegidsnummer 4019615FNR voor alle studenten in het 1e semester met een gespecialiseerd master niveau.

1e semester
Inschrijving onder examencontract
Niet mogelijk
Beoordeling (0 tot 20)
2e zittijd mogelijk
Faculteit Wetenschappen en Bio-ingenieurswetensch.
Verantwoordelijke vakgroep
Pieter Jan Van Der Meer (titularis)
Onderdelen en contacturen
26 contacturen Hoorcollege
10 contacturen Werkcolleges, practica en oefeningen

Background: The development in the early 1970s of recombinant DNA techniques in micro-organisms, followed in the 1980s by genetic modification of plants and animals, provided scientists with the tools to introduce and modify characteristics in plants, micro-organisms and animals with much greater specificity, precision and speed, and with genes from a much greater genetic reservoir than is possible through conventional breeding.

As was recognised in Agenda 21 (1992), and reaffirmed in many subsequent Earth Summits, as well as in international agreements such as the Biodiversity Convention (1992) and the Biosafety Protocol (2000), modern biotechnology has great potential for human well-being and the conservation and sustainable use of biodiversity, if developed and used with adequate safety measures for the environment and human health.

As the Introduction to the Biosafety Protocol says, biosafety systems “create an enabling environment for the environmentally sound application of biotechnology, making it possible to derive maximum benefit from the potential that biotechnology has to offer, while minimizing the possible risks to the environment and to human health”. The application of modern biotechnology and its products is subject to international agreements as well as regional and national regulations for environmental and food safety.

Governance of biotechnology takes place in a context of opposing, and sometimes strongly opposing, views. Some submit that this technology has improved and will improve human well being and the environment, referencing examples as the production bacteria that produce insuline and plants that are made resistant to pests, diseases and drought, thereby reducing the use of chemicals and water in agriculture, and submitting that the experiences with these crops over the last 20+ years have shown no verifiable reports of adverse effects. On the other hand there is much public resistance, particularly in Europe, against the deployment of genetically modified organisms (GMOs), quoting doubts about the need for this technology and safety concerns on the long term.

In this context, the course Biotechnology Regulation, which aims specifically at Biology and Law students, addresses: 

  • modern biotechnology, including new technological developments such as genome editing and synthetic biology, and offers hands-on application of some of these techniques in plants;
  • the structure and key components of biosafety regulations, including the development, implementation and review of regulatory systems;
  • national and regional (e.g. EU) regulations, international agreements (e.g the Cartagena Protocol, Arhus Convention) relevant to modern biotechnology;
  • international organisations (e.g. WHO, WTO), standard setting bodies (e.g  CODEX), and policy declarations (e.g. SDGs) relevant to modern biotechnology;
  • environmental risk assessment, food safety assessment, monitoring, enforcement, sanctions liability, public information, confidential information
  • meetings with practitioners, such as scientists involved in field trials, and - where possible - attending international and EU discussions, as well as meetings with authorities and stakeholders.

While the course Biotechnology Regulation is developed for Master students, a limited number of PhD students and Post-docs, as well as extraneous students, is welcome to participate as observer.

Digitaal cursusmateriaal (Vereist) : Learning materials include national and international regulations , These and other materials will be provided in electronic form on Canvas
Bijkomende info

Unless otherwise indicated by the course instructor via Canvas, attendance of lessons and visits is mandatory.

This course is organised by the Laboratory of Plant Genetics, Faculty of Sciences and Bioengineering Sciences, Vrije Universiteit Brussel (VUB), in collaboration with the Faculty of Law, and the Faculty of Bioscience Engineering, Ghent University, Belgium.


Algemene competenties

Learning outcomes include the ability to:

- understand the scientific and technical aspects as well as the societal context of biotechnological developments 
- analyse relevant international agreements, regional and national laws and regulations
- identify which international, regional and national requirements apply in specific cases
- be able to conduct an environmental risk assessment and a food safety assessment of GMOs
- understand and convey the key differences between monitoring and enforcement, sanctions and liability, public and confidential information


De beoordeling bestaat uit volgende opdrachtcategorieën:
Examen Andere bepaalt 100% van het eindcijfer

Binnen de categorie Examen Andere dient men volgende opdrachten af te werken:

  • Examen andere met een wegingsfactor 30 en aldus 30% van het totale eindcijfer.

    Toelichting: Participation during the course - the student will be evaluated on the basis of the level of participation, comprehension, analytic and legal thinking and verbal expression. For this part there is no alternative.
  • Assignments met een wegingsfactor 30 en aldus 30% van het totale eindcijfer.

    Toelichting: the student will be evaluated on: analysing basic characteristics and ‘open ends’ of international agreements and national legislation, which international agreements national public law apply to specific cases, which provisions apply to specific cases, and the ability to produce a report on a specific case
  • Oral Exam met een wegingsfactor 40 en aldus 40% van het totale eindcijfer.

    Toelichting: The oral exam evaluates knowledge, comprehension, legal thinking, and verbal expression.

Aanvullende info mbt evaluatie

Unless otherwise indicated via Canvas by the instructor: 
1) No show in class will result in zero points for that class

2) late submissions of an assignment will result in zero points for that assignment .

Tenzij anders aangegegven door de instructeur via Canvas:

1) Niet aanwezigheid in een klas resulteert in nul punten voor die klas

2) Niet tijdig indienen van een opdracht resulteert in nul punten 


Toegestane onvoldoende
Kijk in het aanvullend OER van je faculteit na of een toegestane onvoldoende mogelijk is voor dit opleidingsonderdeel.

Academische context

Deze aanbieding maakt deel uit van de volgende studieplannen:
Master in de bio-ingenieurswetenschappen: cel- en genbiotechnologie: medische biotechnologie
Master in de bio-ingenieurswetenschappen: cel- en genbiotechnologie: moleculaire biotechnologie
Master in de bio-ingenieurswetenschappen: cel- en genbiotechnologie: agrobiotechnologie
Master in de bio-ingenieurswetenschappen: chemie en bioprocestechnologie: voedingsbiotechnologie
Master in de bio-ingenieurswetenschappen: chemie en bioprocestechnologie: chemische biotechnologie
Master in de bio-ingenieurswetenschappen: chemie en bioprocestechnologie: biochemische biotechnologie
Master of Molecular Biology: Standaard traject (enkel aangeboden in het Engels)